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Objectives: This study aimed to evaluate the safety and efficacy of remogliflozin compared to vildagliptin as an add-on drug to metformin in type 2 diabetes mellitus (T2DM) treatment. Metformin is considered a first-line drug in T2DM. However, as the disease progresses with heightened insulin resistance and declining β-cell function, the use of metformin alone is often inadequate to achieve optimum glucose levels. Methods: This prospective, randomised study was conducted at Maulana Azad Medical College and Associated Hospital in New Delhi, India, between February 2020 to January 2021. This study recruited 60 T2DM patients aged 35–70 years with glycated haemoglobin (HbA1c) >6.5% taking metformin at a daily dosage of 1,500–3,000 mg for ≥3 months. Patients were randomly assigned in a 1:1 ratio to receive either vildagliptin (50 mg) or remogliflozin (100 mg) twice daily for 90 days. The primary endpoint was a change in HbA1c levels from baseline to the end of 90 days whereas secondary endpoints were changes in lipid profile and weight. Results: The decrement in mean HbA1c levels was significantly higher in the remogliflozin group than in the vildagliptin group (−8.1% versus −2.4%; P <0.001). In addition, more significant weight loss was found in remogliflozin-treated patients (−5.2% versus −0.6%; P <0.01). Both treatments were well tolerated throughout the study. Conclusion: Compared to vildagliptin, remoglilflozin was significantly more effective in glycaemic control and weight loss in patients with T2DM and can therefore be considered as an add-on drug in T2DM not adequately controlled by metformin monotherapy. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the perception of clinicians about the association of heart failure (HF) and type 2 diabetes mellitus (T2DM) and the utilization of dapagliflozin-based combination therapies for cardiorenal protection in Indian patients with T2DM. Materials and Methods: This cross-sectional, digital questionnaire-based study involved diabetologists and consulting clinicians from pan-India and was conducted between October 2022 and March 2023. Results: Of the 982 clinicians, 871 completed the study. According to 90.93% and 47.19% of clinicians, most patients with T2DM were in the age group of 40–60 years, and cardiovascular (CV) risk is present in 3 in 10 of T2DM patients, respectively. As the initial choice of oral antidiabetic class (other than metformin), 43.86% of clinicians preferred sodium-glucose cotransporter-2 inhibitors (SGLT2i). Dapagliflozin is the most effective SGLT2i in reducing mortality/hospitalization in T2DM patients with HF (70.38%). In T2DM patients with CV/renal risk, 66.02% of clinicians recommended dapagliflozin with sitagliptin (10 mg + 100 mg strength) as SGLT2i plus dipeptidyl peptidase-4 inhibitors (DPP4i) fixed-dose combination (FDC). The use of a triple-drug FDC of dapagliflozin plus sitagliptin plus metformin was strongly recommended by 74.40% of clinicians. Early initiation and intensification with a combination of SGLT2i and DPP4i in young T2DM patients (30–50 years) inadequately managed on metformin was highly recommended (94.58%). The majority of clinicians opined that SGLT2i should be initiated in all T2DM patients with comorbidities to prevent HF complications (97.58%), and SGLT2i is underutilized in India for the treatment of HF in T2DM patients (89.21%). Conclusion: The overall observations provide insights into the usage patterns of dapagliflozin-based combination therapies for cardiorenal protection among Indian T2DM patients. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy and safety of fixed-dose combinations (FDC) of triple-drug dapagliflozin, sitagliptin, and metformin (DSM) compared with FDC of two-drug sitagliptin and metformin (SM), in Indian adult patients with type 2 diabetes (T2D). Methods: A multicentric, randomized, double-blind, active-controlled, Phase 3 study (CTRI/2021/10/037461) was conducted on 274 Indian adult patients with T2D. Patients were randomized (1:1) to receive either an FDC of triple-drug (n = 137) dapagliflozin propanediol 10 mg, sitagliptin phosphate 100 mg, and metformin hydrochloride 1000 mg extended-release (DSM) or FDC of two-drug (n = 137) sitagliptin phosphate 100 mg and metformin hydrochloride 1000 mg sustained-release (SM), for 16 weeks. The primary endpoint was a change in HbA1c, while the secondary endpoints were changes in fasting plasma glucose (FPG), postprandial glucose (PPG), body weight, and safety. Results: Both DSM and SM FDCs reduced HbA1c significantly (-1.45% and -1.00%, respectively, both p < 0.0001), however, HbA1c lowering was superior with DSM (∆ -0.45%; p = 0.0005) compared to SM, at week 16. Similarly, both DSM and SM FDCs reduced FPG and PPG significantly, however, FPG (∆ -12.4 mg/dl; p = 0.003) and PPG reduction (∆ -18.45 mg/dl; p = 0.01) were significantly superior to DSM compared to SM, respectively. No significant reduction in body weight was observed between the two arms. Both FDCs were well tolerated. Conclusion: FDC of DSM was superior to SM in reducing HbA1c, FPG, and PPG in Indian adults with T2D. Both triple and dual FDCs had optimal safety profiles. [ABSTRACT FROM AUTHOR]

Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor is effective in reducing HbA1c levels in patients with type 2 diabetes (T2DM) when administered as monotherapy, dual or triple combination therapy. In India, Vildagliptin is commonly prescribed in T2DM patients because it reduces mean amplitude of glycemic excursion (MAGE), has lower risk of hypoglycemia and is weight neutral. Early combination therapy with vildagliptin and metformin is effective and well-tolerated in patients with T2DM, regardless of age or ethnicity. In view of already existing data on vildagliptin and the latest emerging clinical evidence, a group of endocrinologists, diabetologists and cardiologists convened for an expert group meeting to discuss the role and various combinations of vildagliptin in T2DM management. This practical document aims to guide Physicians and Specialists regarding the different available strengths and formulations of vildagliptin for the initiation and intensification of T2DM therapy. [ABSTRACT FROM AUTHOR]

Introduction: Diabetes mellitus is a pandemic disease that has struck each and every corner of the world. According to the Indian Council of Medical Research-Indian Diabetes study (ICMR), a national diabetes study, India currently has 62.4 million people with diabetes. This is set to increase to over 100 million by 2030. The prevalence of diabetes among adults has reached approximately 20% in urban and approximately 10% in rural populations in India. Materials and Methods: This prospective observational study was carried out for a period of 1 year from January 2023 to December 2023 at Department of General Medicine, Tagore Medical College Hospital, Rathinamangalam, Melakottaiyur, Chennai. A total of 1113 patients were screened, from which 138 cases of DM aged between 20 to 80 yrs. Who were under treatment and following life style modification and diet advice were included in the study. Majority of the patients belonged to low and middle socioeconomic groups. Patients not willing for informed consent, those with diabetic complications and serious medical conditions requiring subsequent hospital admissions, prediabetic status, Gestational Diabetes were excluded from the study. Results: The prevalence was about 6.19% and 68.11% of them were 40-60 years of age. Metformin was the most commonly prescribed drug and 21.74% of patients were on monotherapy. Glimepiride and Metformin (33.33%) was the mostly used oral combination followed by Glibenclamide and Metformin (8.69%). Inj. Human Mix insulin with Metformin was used in 27.53%. 15.94% of patients were on statins. The most common comorbid condition was hypertension (21.73%) followed by dyslipidaemia (8.6%). Conclusion: With increasing prevalence of the disease, this study provides an insight to create awareness about the drug usage among rural population. OADs are still the predominantly prescribed drugs, but there was a shift towards the use of insulin in the management of Type 2 diabetes mellitus. Intensification of current drug treatment as well as planning multiple drug interventions with lifestyle modification is necessary. Metformin is the most commonly used drug and among the sulfonylureas Glimepiride is the most commonly used. [ABSTRACT FROM AUTHOR]

Aim of the study: determine the pattern of prescription of Anti Diabetic Drugs in a cohort of patients at a tertiary care centre of East Nimar region of Central India. Methods: The study was a Prospective observational study and was conducted in the Outpatient department of Medicine conducted for a period of 6 Months. Demographic and clinical data of total 82 patients were collected and Prescription of these Diabetic patients were analysed. Result: Out of Total 82 Patients, the maximum percentage of Diabetic patients, including both males and females belonged to the age group of 51 to 60 years (36.58%). Majority of Patients received Two Drug Anti-diabetic Drug combination (i.e. Metformin and Glimepiride combination) which were the most prescribed drugs (65.85%, 54 Patients out of total 82 Patients) followed by Mono-therapy with Metformin (13.41%, 11 Patients out of total 82 Patients). Among the three drugs combination therapy prescribed in 15 patients (18.29%), often Metformin + Glimepiride + Pioglitazone combination were prescribed (6 patients, 7.31%), followed by Metformin + Glimepiride+ Vildagliptin/Tenegliptin/Sitagliptin (DPPIV Inhibitors) (5 patients, 6.09 %). As far as comorbid conditions are concerned 62 Patients (75.60 %) had no comorbid disease along with Diabetes, 20 patients (24.39 %) had Hypertension and 3 patients (3.65 %) had Hyperlipidaemia along with Hypertension and Diabetes and received concomitant medications for the same. Conclusions: The present study represents the current prescribing pattern of Anti-Diabetic Drugs in our Hospital. Our findings showed that Metformin and Glimepiride combination dominated thescenario followed by Monotherapy with Metformin among the elderly populations of Diabetes. The use of Anti-Diabetic drugs largely confirms the guidelines as most of the patients belonged to the category of elderly populations, but still there is a significant room of improvement in terms of rational prescribing. [ABSTRACT FROM AUTHOR]

Introduction: The prevalence of Polycystic Ovarian Syndrome (PCOS), one of the common endocrine disorders among women of reproductive age, varies from 2.2% to 26% globally. The treatment for PCOS aims to reduce Body Mass Index (BMI), improve underlying hormonal disturbances, prevent future reproductive and metabolic complications, and enhance the quality of life. Aim: To evaluate the efficacy of metformin and Myoinositol (MI) on the metabolic, hormonal, and clinical profiles in PCOS. Materials and Methods: An open-label randomised clinical trial was conducted at the Department of Obstetrics and Gynaecology, SRM Medical College Hospital and Research Centre, Kattankulathur, Chengelpet, Tamil Nadu, India, from January 2019 to May 2020. The study included 80 women with PCOS who were randomly assigned to two groups. One group received metformin 1500 mg/day (in three divided doses), while the other group received MI 1 gram/day for three months. At the end of the 12-week therapy, the participants were evaluated for changes in clinical, metabolic, and hormonal profiles. The data were analysed using Statistical Package for Social Sciences (SPSS) version 20.0. Descriptive statistics such as frequency, proportion, mean, and standard deviation were used for quantitative data. Results: Both the metformin and MI-treated groups showed a significant reduction in BMI, fasting blood glucose, and fasting insulin. Both drugs were equally effective in changing the hormonal profile. There was a significant improvement in lipid parameters in both groups, with High-density Lipoprotein (HDL) levels being more significantly raised in the metformin group. The post-treatment HDL values in the metformin group were 75.69±19.16 mg/dL compared to 41.43±6.18 mg/dL in the MI group (p<0.0001). Both groups demonstrated similar efficacy in improving menstrual regularity, with 60% of the patients in the metformin group and 65% in the MI group having regular cycles at the end of treatment. Among infertility patients, the conception rate was 40% in the metformin group and 25% in the MI group (p=0.70). Conclusion: Both drugs were equally efficient in improving the clinical, metabolic, and hormonal profiles in PCOS. Metformin was found to be superior to MI in improving fertility and increasing HDL levels. [ABSTRACT FROM AUTHOR]

Introduction: The aim of the study was to evaluate the efficacy and safety of fixed-dose combination (FDC) of dapagliflozin (10 mg) and linagliptin (5 mg) in comparison to linagliptin 5 mg (Trajenta) in patients with insufficiently controlled type 2 diabetes mellitus (T2DM) on metformin monotherapy. Methods: The double-blind, randomized, multicentric, parallel-group phase III trial screened 287 adult patients with T2DM (age 18–65 years) from 16 sites across India. The recruited subjects were undergoing metformin monotherapy ≥ 1000 mg/day for at least 28 days. Patients with HbA1c of 7.5–10.5% (58–91 mmol/l) (n = 232) after 2 weeks of run-in period with linagliptin monotherapy and placebo dapagliflozin/linagliptin on metformin monotherapy were randomized (1:1) in parallel to once daily dapagliflozin/linagliptin 10/5 mg or linagliptin 5 mg for 16 weeks. Patients were stratified on the basis of HbA1c (≤ 9.0% and > 9.0%; ≤ 75 mmol/l and > 75 mmol/l)). A total of 225 subjects completed 16 weeks of treatment, 115 patients in the test group and 110 patients in the reference group. Results: Dapagliflozin/linagliptin (p = 0.0003) exhibited a greater change in HbA1c from baseline than linagliptin (p < 0.0001) in 16 weeks (mean reduction, − 1.28% vs − 0.83%). Test group showed a significant decrease in fasting plasma glucose (FPG), postprandial plasma glucose (PPG) and body weight compared to the reference group. The FDC was well tolerated with adverse events being more frequent in the reference group. No serious adverse events (SAEs) were reported in the study. Conclusion: Dapagliflozin/linagliptin combination is a novel dipeptidyl peptidase 4 (DPP4)/sodium-glucose co-transporter 2 (SGLT2) inhibitor FDC approved in India for patients with T2DM. Potential limitations of this study are a small dose of dapagliflozin (10 mg) in the FDC, a short study duration (30 weeks) and a high minimum threshold for HbA1c (≤ 7.5%; ≤ 53 mmol/l). Results indicate the FDC to be a superior therapeutic option over linagliptin for patients with T2DM on metformin monotherapy. Trial Registration: CTRI/2022/08/044563; 01/08/2022. [ABSTRACT FROM AUTHOR]

Sulfonylureas (SU) continue to be a vital therapeutic category of oral hypoglycemic agents (OHAs) for the management of type 2 diabetes mellitus (T2DM). Physicians consider modern SU (gliclazide and glimepiride) as "safe and smart" choices for T2DM management. The presence of multiple international guidelines and scarcity of a national guideline may contribute to the challenges faced by few physicians in choosing the right therapeutic strategy. The role of SU in diabetes management is explicit, and the present consensus aims to emphasize the benefits and reposition SU in India. This pragmatic, practical approach aims to define expert recommendations for the physicians to improve caregivers' knowledge of the management of T2DM, leading to superior patient outcomes. [ABSTRACT FROM AUTHOR]

Background: Globally, medicinal plants are used to treat diseases like diabetes. The present study evaluates the possible antioxidant, acute oral toxicity, the in-vitro and in-vivo antidiabetic potential of the hydro-ethanolic leaf extract of Koenigia polystachya (HELeKP) against beta-cell damage in experimentally induced diabetes mellitus. The DPPH (2,2-diphenyl-1-picrylhydrazine), ABTS [2,2′-azino bis-(3-ethylbenzothiazoline-6-sulfonic acid)], H2O2 (Hydrogen peroxide), superoxide radical scavenging activity and NO (Nitric oxide) assay estimated the in-vitro antioxidant assay of HELeKP. The acute oral toxicity study was evaluated per the OECD (Organization for Economic Cooperation and Development) test guidelines 425. Diabetes was stimulated in rats with a single dose of Streptozotocin (STZ), and after confirmation of diabetes, HELeKP was given orally for 21 days. Blood/serum samples were gathered and examined for biochemical changes, while tissue samples were evaluated for histopathological alterations. Results: The IC50 value of the HELeKP for all the anti-oxidant assays confirms the free radical scavenging activity. The data on acute oral toxicity revealed that the HELeKP used in the study was comparatively very safe. The outcomes of the in-vivo study suggested that the extract significantly reduced (p < 0.001) the fasting glucose level in STZ-induced diabetic rats. Furthermore, the lipid profile level was significantly normalized (p < 0.01, p < 0.001) in diabetic rats. The histopathological observation of the pancreas in HELeKP-treated rats showed significant beta-cell restoration. Conclusions: Based on the outcomes of this study, the HELeKP-treated rats have significant free radical scavenging and anti-diabetic potential. Therefore, it can be recommended as a beneficial functional vegetable for consumption. [ABSTRACT FROM AUTHOR]

Objective: Polycystic ovary syndrome (PCOS) is a pathophysiological disorder affecting reproductive and metabolic indices in females. The present study was designed to compare the efficacy of metformin and D-chiroinositol in PCOS patients. Methods: In a tertiary care hospital in North India, prospective observational research was undertaken on 100 patients with PCOS, which was diagnosed based on European Society of Human Reproduction and Embryology Guidelines and ultrasound of lower abdomen. The study involves various clinical characteristics into consideration for the determination of statistical significance (P < 0.05) in PCOS patients. Student's t -test along with the association between PCOS and patients taking metformin and D-chiro-inositol, as well as their impact on various biochemical parameters, were investigated finally using Pearson Correlation Analysis. Results: This study comprises 50 patients taking metformin and 50 patients taking D-chiro-inositol in women suffering from PCOS. Body mass index (BMI) and waist-to-hip ratio (WHR) were statistically significant (P < 0.05) within the groups of both metformin and D-chiro-inositol. Biochemical parameters such as luteinizing hormone (LH), follicle stimulating hormone (FSH), anti-mullerian hormone (AMH) and glycated hemoglobin (HbA1c) were found to be statistically significant (P < 0.05) in both groups. LH, FSH and AMH (14.40 ± 0.52; 14.28 ± 0.53; 1.99 ± 0.10) were comparatively lower in patients taking D-chiro-inositol as compared to metformin group (14.17 ± 0.42; 19.88 ± 1.01; 2.61 ± 0.04). HbA1c (3.71 ± 0.08) with P < 0.05 was found to be decreased more in metformin group as compared to patients taking D-chiro-inositol (4.90 ± 0.09). A positive correlation was found between HbA1c and LH in metformin, & HbA1c and FSH in D-chiro-inositol groups, respectively. Conclusion: The results indicate that D-chiro-inositol shows better results in reducing clinical variables involved in causing PCOS as compared to metformin whereas metformin has better glycemic control in PCOS patients. [ABSTRACT FROM AUTHOR]

Background: Diabetes mellitus (DM) refers to a group of common metabolic disorders that share the phenotype of hyperglycemia. Depending upon the etiology of DM, factors contributing to hyperglycemia include reduced insulin secretion, decreased glucose utilization and increased glucose production. Objective: To study the hematological parameters and vitamin B12 level in type 2 diabetics on long term metformin therap. Material and Methods: The present prospective observational case control study was carried out at tertiary care centre of central India from Jan 2021 to December 2022. Approval from the Institutional Ethics Committee was sought. Informed consent in subject's vernacular language was taken. Sample size was 204 (102 in each group - case and control). Results: 67.44 % (29/43) vitamin B12 deficient cases had macrocytes in their peripheral smear which was statistically significant. The mean vitamin B 12 level was lower in cases than in controls which was statistically significant.( p value <0.05). 42.1% (43/102) cases and 10.7% (11/102) controls had vitamin B12 deficiency. As compared to the control group, more subjects in Diabetic group had vitamin B12 deficiency which was statistically significant. Age was seen to be positively associated with the incidence of Vitamin B12 deficiency. 51.9% (53/102) of cases had diabetes for less than 10 years and 48.1% (49/102) of cases had diabetes for more than 10 years. 52.9% (54/102) diabetic cases were on metformin therapy for less than 10 years and 47.1% (48/102) cases were on metformin therapy for more than 10 years. Prolonged duration of Metformin therapy significantly associated with serum vitamin B12 deficiency. (p value <0.01). Conclusion: In the present study, prolong duration of diabetes and prolong use of metformin were associated with vitamin B12 deficiency. Macrocytosis was correlated with vitamin b12 dficiency. [ABSTRACT FROM AUTHOR]

Background- Additionally, the prevalence of prediabetes in India ranged from 10% to 14%, which is higher than the global prevalence of 8%. Dyslipidemia, characterized by elevated levels of low-density lipoprotein cholesterol (LDLc), elevated tri-acylglycerol (TG), and decreased levels of high-density lipoprotein cholesterol (HDLc), is linked to an augmented risk of cardiovascular disease (CVD). Consequently, the timely identification and management of dyslipidemia can significantly contribute to the prevention of cardiovascular morbidity and mortality. Methods- This is a Prospective observational cohort study, A total of 240 patients from Outpatient department (OPD) and Indoor patient (IPD) department of Medicine, Dr. Baba Saheb Ambedkar Medical college and Hospital, New Delhi, were taken for study considering the inclusion and exclusion criteria. The data was collected in a pre test proforma which includes various socio-economic parameters like age, sex, occupation, religion, etc Results - The mean age of participants was 53.020+-16.5 years, and mean BMI of 24.555±12.8 kg/m2. All patients, exhibited total cholesterol levels that fell within the range considered to be normal following the administration of the prescribed therapy. The mean total cholesterol level recorded was 141.2mg/dl. In the study, it was observed that 75% of the participants experienced a reduction in their cholesterol levels. On the other hand, a small percentage of 1.25% showed an increase in their cholesterol levels. Additionally, 23% of the participants demonstrated no significant change in their cholesterol levels, with a margin of error of plus or minus 10mg/dl, when compared to their baseline measurements. Conclusion- There was a notable enhancement in the average values (moving closer to the normal distribution) of each lipid profile parameter over time. The findings of the study indicate that the utilization of metformin resulted in improvements in lipid parameters. [ABSTRACT FROM AUTHOR]

The objective of the present study was to evaluate the Drug utilisation pattern in patients of diabetic nephropathy (stage 1–4) in a tertiary care hospital in South-Asia. A cross-sectional observational study was conducted in the nephrology out-patient-department of a tertiary care hospital in South-Asia. WHO core prescribing, dispensing, and patient care indicators were evaluated, and adverse drug reactions (ADRs) encountered by the patients were analysed for causality, severity, preventability, and outcome. The most commonly prescribed antidiabetics in diabetic nephropathy patients were insulin (17.42%), followed by metformin (4.66%). Current drugs of choice SGLT-2 inhibitors were prescribed in a lesser frequency than expected. Loop diuretics and calcium channel blockers (CCBs) were the preferred antihypertensives. The use of ACE inhibitors (1.26%) and ARBs (3.45%) for hypertension was restricted to Stage 1 and 2 nephropathy. The patients were on 6.47 drugs on average. 30.70% of drugs were prescribed by generic names, 59.07% of the drugs were prescribed from the national essential drugs list and 34.03% of the prescribed drugs were supplied by the hospital. CTCAE grade 1 (68.60%) and grade 2 (22.09%) ADR severity was the highest. Prescribing patterns in patients of diabetic nephropathy were adapted from relevant medical evidence, affordability and availability of the drugs. Generic prescribing, availability of drugs and ADR preventability in the hospital have a broad scope for improvement. [ABSTRACT FROM AUTHOR]

(1) Background: There is a high burden of poor glycemic control in the Indian population with type 2 diabetes mellitus (T2DM). Currently, the use of metformin sustained-release (SR)–vildagliptin fixed-dose combination (FDC) is very low as compared to metformin immediate-release (IR)–vildagliptin FDC which is associated with higher adverse events (AEs). Here, we present real-world effectiveness of metformin SR–vildagliptin FDC treatment in patients with T2DM; (2) Methods: This retrospective analysis was carried out from the medical records of adult T2DM patients visiting a single study center in India (December 2020–February 2021). A total of 10 patients (aged ≥20 years) were treated with vildagliptin 50 mg and metformin SR 500 mg FDC for 15 days. The treatment response was assessed by the percentage of time spent in the target glucose range (TIR at baseline and 15 days after treatment); (3) Results: The glycated hemoglobin (HbA1c) levels at baseline varied between 6.5% to 12%. The glycemic control improved in 70% of patients (mean increase in TIR: 18.9%). Treatment adherence was 100%. No gastrointestinal symptoms or AEs were reported; (4) Conclusions: Early intervention with metformin SR–vildagliptin FDC in patients with T2DM can ensure therapy compliance in terms of superior efficacy along with safety and tolerability. Key summary points: Early initiation of combination therapy helps in early achievement of glycemic goals; Early initiation of metformin and vildagliptin FDC results in significant glycemic control with good tolerability and compliance; Metformin SR–vildagliptin FDC has lower adverse events, compared to metformin IR–vildagliptin FDC; A case series of ten patients with T2DM treated with metformin SR–vildagliptin FDC is presented to assess the real-world effectiveness of this combination. [ABSTRACT FROM AUTHOR]

Objectives: Diabetes is more prevalent in middle- and higher-income groups and is spreading at an alarming rate. Drug therapy is compulsory because of the chronic and progressive nature of the disease. With such multifactorial background of high prevalence, progressive nature of the disease leading to various complications, increased healthcare cost, and availability of multiple therapeutic regimens prescribed, this study has been done to evaluate the cost-effective analysis of oral hypoglycemic agents. Materials and Methods: This is a prospective, parallel group, and comparative observational study conducted by the Department of Pharmacology in collaboration with the Department of Endocrinology at Kalinga Institute of Medical Sciences, Bhubaneswar. The duration of the study was of 2 years. A total number of 220 patients were selected and based on body mass index, patients were categorized into preobese (new and old diabetic patients) and obese (new and old diabetic patients) categories. In this study, cost-effectiveness analysis (CEA) was done to evaluate the cost differences between two or more medication groups, with a similar clinical effect. Results of CEA are expressed as an average cost-effectiveness ratio or as an incremental cost-effectiveness ratio. Results: From this study, it is observed that in terms of benefit, dual therapy of Metformin and Dapagliflozin was most efficacious followed by Metformin and Sitagliptin as well as Metformin and Glimepiride combinations. If cost is considered, Metformin montherapy and metformin and Glimepiride dual therapy was most cost-effective. In triple regimen, MET+VOG+GLIM combination was seen to be more cost effective than gliptin combination, both in terms of control of FBS as well as PPBS. The cost of treatment goes parallel with duration of disease, being higher in the old cases of long-standing duration. Conclusion: The present study shows that SGLT2 inhibitors are better class of oral hypoglycemics in terms of longterm benefits and this group is prescribed as dual therapy more frequently but cost of therapy is the greatest barrier. Metformin and Sulfonylureas remain the most beneficial combination, both in terms of efficacy and cost. The cost of treatment was varying, depending on the duration of disease, being higher in old cases and lower in new cases. [ABSTRACT FROM AUTHOR]

The article presents recommendations for the management of Type 2 Diabetes Mellitus based on clinical practice done by the Research Society for the Study of Diabetes in India (RSSDI). It analysis the study to assess the diagnostic accuracy, criteria, and optimal glycosylated hemoglobin (HbA1c) for diabetes and prediabetes.

Context: Metformin is known to increase in the risk of developing vitamin B12 deficiency. This study aimed to compare the effectiveness of nasal spray of methylcobalamin (NASO B12) and methylcobalamin tablets for treating vitamin B12 deficiency in diabetic patients receiving metformin. Materials and Methods: In this parallel-group, comparative, open-label clinical study, patients (n = 100) were assigned to two groups: nasal spray of methylcobalamin (NASO B12) (methylcobalamin 250 µg/spray), sprayed in each nostril every alternate day for a total of seven doses (Group 1: a total of 3500 µg methylcobalamin per patient) and oral methylcobalamin tablets, a single daily dose of 1500 µg for a total of seven doses (Group 2: a total of 10,500 µg methylcobalamin per patient). The assessment of efficacy was carried out by measuring serum vitamin B12 levels at baseline, day 7, and day 14. Statistical Analysis Used: The analysis used is Student’s unpaired t-test. Results: NASO B12 treatment resulted in vitamin B12 levels of ≥400 pg/mL (recently updated normal levels as per American Academy of Family Physicians) in 86% and 92% of patients, on day 7 and day 14, respectively, whereas no patient attained ≥400 pg/mL with oral therapy. NASO B12 therapy resulted in higher mean vitamin B12 levels of 485.88 and 570.16 pg/mL when compared with 172.26 and 185.44 pg/mL with oral tablets on day 7 and day 14, respectively. Conclusion: NASO B12 provided much superior absorption of vitamin B12 when compared with oral vitamin B12 tablets and can be used as an effective alternative. [ABSTRACT FROM AUTHOR]

The skeletal effects of metformin monotherapy and in combination with teneligliptin are not well illustrated in patients with T2DM. To address this, we conducted an observational study to evaluate the effect of these oral hypoglycemic agents on bone turnover markers. We recruited patients with T2DM and first-ever prescribed metformin monotherapy or metformin combined with teneligliptin from a tertiary care teaching hospital in New Delhi, North India. Both bone formation and resorption markers, IL-6 and PTD, were estimated along with glycated hemoglobin at baseline and 12 weeks. In both groups, hbA1c levels decreased significantly from baseline to 12 weeks. In the metformin-treated group, β-CTX, sRANKL, IL-6, and PTD decreased significantly, and no significant changes were observed in P1NP, OC, BAP, or OPG at 12 weeks from baseline. In the metformin + teneligliptin group, BAP, β-CTX, sRANKL, IL-6, and PTD decreased significantly, and no significant changes were observed in P1NP, OC, or OPG after 12 weeks from baseline. The positive bone outcome of metformin or teneligliptin was linked to bone resorption rather than bone formation and was independent of changes in HbA1c or PTD. However, these results must be confirmed with well-designed RCTs with more extended follow-up periods. [ABSTRACT FROM AUTHOR]

Here, through this review, we aim to serve this purpose by first discussing the statistics and aging demographics, including the life expectancy of the world and India, along with the gender life expectancy gap observed throughout the world, followed by explaining the hallmarks and integral causes of aging, along with the role played by senescent cells in controlling inflammation and the effect of senescence associated secretory phenotype on longevity. A few of the molecular pathways which are crucial in modulating the process of aging, such as the nutrient‐sensing mTOR pathway, insulin signaling, Nrf2, FOXO, PI3‐Akt, Sirtuins, and AMPK, and their effects are also covered in paramount detail. A diverse number of ingenious research methodologies are used in the modern era of longevity exploration. We have attempted to cover these methods under the umbrella of three broad categories: in vitro, in vivo, and in silico techniques. The drugs developed to attenuate the aging process, such as rapamycin, metformin, resveratrol, etc. and their interactions with the above‐mentioned molecular pathways along with their toxicity have also been reviewed in detail. [ABSTRACT FROM AUTHOR]

Molineria recurvata (MR) has been traditionally used to manage diabetes mellitus in India. However, the molecular mechanism of MR on the diabetic-induced nephropathy has not been clearly investigated. Thus, this study investigates the protective effects of the MR extract on nephropathy in streptozotocin (STZ)-induced diabetic rats. Diabetes was instigated by a single intraperitoneal injection of STZ (45 mg/kg) in male Sprague-Dawley rats. Once the diabetes was successfully induced, the MR extract (200 mg/kg/day) or metformin (200 mg/kg/day) was orally administered for 14 days. Renal function, morphology changes and levels of inflammatory cytokines were measured. Blood glucose concentrations were considerably reduced in STZ-induced diabetic rats following treatment with the MR extract. The administration of the MR extract substantially restored the abnormal quantity of the oxidative DNA damage marker 8-hydroxy-2′-deoxy-guanosine (8-OHdG), malondialdehyde, glutathione, oxidized glutathione, superoxide dismutase, catalase, interleukin (IL)-1β, IL-6, IL-10, and transforming growth factor-β (TGF-β). The urinary excretion of kidney injury molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), selenium binding protein 1 (SBP1), and pyruvate kinase M2 (PKM2) was significantly reduced in diabetes rats after administration of the MR extracts. In the kidneys of STZ-induced diabetic rats, the MR extracts markedly downregulated the expression of fibronectin, collagen-1, and α-smooth muscle actin (α-SMA). In particular, the MR extracts markedly increased the level of SIRT1 and SIRT3 and reduced claudin-1 in the kidney. These results suggest that the MR extracts exhibits therapeutic activity in contrast to renal injury in STZ-induced diabetic rats through repressing inflammation and oxidative stress. [ABSTRACT FROM AUTHOR]

Background Metformin, by reducing intracellular Mycobacterium tuberculosis growth, can be considered an adjunctive therapy to anti-tuberculosis treatment (ATT). We determined whether metformin with standard ATT reduces time to sputum culture conversion and tissue inflammation in adults with pulmonary tuberculosis (PTB). Methods In a randomized, 8-week, clinical trial, newly diagnosed, culture-positive PTB patients were randomized to standard ATT (HREZ = control arm) or standard ATT plus daily 1000 mg metformin (MET-HREZ = Metformin with Rifampicin [METRIF] arm) for 8 weeks during 2018–2020 at 5 sites in India. The primary end point was time to sputum culture conversion by liquid culture during 8 weeks of ATT. Plasma inflammatory markers were estimated in a subset. A Cox proportional hazard model was used to estimate time and predictors of culture conversion. Results Of the 322 patients randomized, 239 (74%) were male, and 212 (66%) had bilateral disease on chest radiograph with 54 (18%) showing cavitation. The median time to sputum culture conversion by liquid culture was 42 days in the METRIF arm and 41 days in the control arm (hazard ratio, 0.8; 95% confidence interval [CI],.624–1.019). After 8 weeks of ATT, cavitary lesions on X-ray (7, 5.3% vs 18, 12.9%; relative risk, 0.42; 95% CI,.18–.96; P  = .041) and inflammatory markers were significantly lower in the METRIF arm. Higher body mass index and lower sputum smear grading were associated with faster sputum culture conversion. Conclusions The addition of metformin to standard ATT did not hasten sputum culture conversion but diminished excess inflammation, thus reducing lung tissue damage as seen by faster clearance on X-ray and reduced inflammatory markers. Clinical Trials Registration Clinical Trial Registry of India (CTRI/2018/01/011176) [ABSTRACT FROM AUTHOR]

Introduction: Type 2 diabetes (T2DM), which is more prevalent (more than 90% of all diabetes cases) and the main driver of the diabetes epidemic, now affects 5.9% of the world's adult population, with almost 80% of the total in developing countries. At present, 537 million adults (20–79 years) are living with diabetes—1 in 10. This number is predicted to rise to 643 million by 2030 and 783 million by 2045. In India, reports show that 69.2 million people are living with diabetes (8.7%) as per 2015 data. Long-term metformin treatment is a known pharmacological cause of vitamin B12 (Vit B12) deficiency, as was evident within the first 10–12 years after it started to be used. Methods: This was a cross-sectional study conducted in the Postgraduate Department of Medicine in one of the tertiary hospitals in Kashmir. A total of 1600 consecutive patients with T2DM were taken for the study. Out of which 700 patients met the inclusion criteria. These 700 patients were divided into two groups: those taking metformin, and those who were not on metformin. Cumulative metformin doses were recorded in patients taking metformin, using history of dose and duration of treatment. Serum Vit B12 levels were taken for all patients. Based on the results of Vit B12 levels, patients were classified into normal levels (20 pmol/L), possible B12 deficiency (150–220 pmol/l), and definite deficiency (<150 pmol/L). Results: Our results depicted that patients on prolonged metformin therapy showed an increase in Vit B12 deficiency by 11.16%. The prevalence of clinical neuropathy in the metformin-exposed group was 45%, whereas, a prevalence of 31.8% was found in the non-metformin group. The mean age of patients with neuropathy was higher than those without neuropathy (59.01 ± 7.14 vs. 49.95 ± 7.47) (p-value < 0.514, statistically insignificant). Conclusions: In our study, we found that metformin use is associated with Vit B12 deficiency, which is dependent upon the cumulative dose of metformin. Importantly, prolonged metformin use is also associated with an increase in the prevalence of clinical neuropathy. [ABSTRACT FROM AUTHOR]

Background: Over the last few years, an unexpected increase in the prevalence of diabetes in India have been witnessed. The present study was planned to analyse prescribing patterns of anti-hyperglycaemic drugs and assess the influence of Chief Minister's Free Drug Scheme in Rajasthan, India. It aimed to evaluate, monitor and if possible, suggest modifications in prescribing practices to make medical care rational and also to assist minimising adverse drug reactions (ADRs). Methods: This was a cross-sectional, observational study carried out for a 12-month period. A total 400 known patients of type 2 diabetes mellitus (T2DM) from endocrinology outdoor of SMS Medical College Hospital (a tertiary care hospital in Jaipur, Rajasthan, India) were recruited and their prescriptions were analysed using the World Health Organization (WHO) prescribing indicators. Results: Most commonly observed age group was of 40-50 years (mean age 53.76 ± 8.84), with a male preponderance (57.5 %). Among them, 67.5 % of patients were found to be obese (mean BMI 29.79 ± 3.26). All anti-hyperglycaemic were prescribed in their generic names only. Metformin was the most frequently prescribed anti-hyperglycaemic agent. Among the fixed dose combinations, the most common was that of glimepiride and metformin (40.75 %), while most prescribed add on anti-hyperglycaemic was teneligliptin (51.5 %), followed by pioglitazone (30.5 %). A total of 53.25 % of these patients received insulin along with oral anti-hyperglycaemic agents. Conclusion: The anti-hyperglycaemic agent prescribing among endocrinology outpatients at tertiary care hospital in Jaipur was found to be satisfactory. [ABSTRACT FROM AUTHOR]

Aim: Maturity-onset Diabetes of Young (MODY) is a monogenic form of diabetes affecting 1-5% of young (often ≤25 years) diabetic patients exhibiting an autosomal dominant mode of inheritance. Considering the significance of genetic polymorphisms in a variety of diseases, this study aimed to determine the association between HNF4α and GCK gene polymorphisms and the risk of MODY in the Kashmir community, as well as their clinical differences.Method: The study was conducted on clinically confirmed MODY patients (n = 50), and age and gender-matched controls (25 T1DM and 25 non-diabetic) recruited from the endocrinology department of the hospital, for evaluating the HNF4α and GCK mutation. Under standard conditions, PCR-mediated amplification was done to evaluate the respective exons. Preliminary mutations were detected using restriction enzymes (BfaI and HhaI), which were then followed by sequencing of representative samples. The diabetic history, clinical and biochemical data were obtained after proper consent.Results: Our data revealed no association of HNF4α (exon7) and GCK (exon8) gene mutation with MODY disease susceptibility in the Kashmiri population. On diagnosis, no MODY patient was given immediate insulin; instead, metformin (68%) or sulphonyl-urea (28%) and dietary changes (4%) were recommended. Later in life, 54% of MODY patients develop insulin dependency. The MODY probability was calculated to be 73.88% (±4.56). HbA1c levels were lower [7.48% (±1.64)] than in T1DM [9.17(±2.29%)].Conclusions: Young early-onset diabetic patients were able to keep their HbA1c and blood glucose levels stable with a modified diet and metformin/sulphonyl-urea, but they may become insulin-dependent in the future, as seen in our study. As a result, prompt diagnosis and management are essential for avoiding complications. Furthermore, no HNF4α (exon7) or GCK (exon 8) mutations were found in MODY patients or T1DM/healthy non-diabetic controls. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes mellitus (T2DM) is a progressive disease affecting a huge chunk of the population globally. Aim: This study aimed to address the existing gaps in knowledge about the triple-drug combination and to provide guidance to the clinicians on the triple-drug combination in Indian settings. Materials and Methods: Doctors’ opinions (n = 2262) were recorded based on surveys and round table meetings. The National Expert Group approved a standard questionnaire that included 13 questions pertaining to T2DM management using a triple combination of glimepiride, metformin, and voglibose, which were prepared, discussed, and evaluated by the experts. After due discussions, the expert group analyzed the result and further recommendations were made and a consensus statement was derived. Results: Out of 2262, 1498 were consulting physicians, 358 were diabetologists, 93 were endocrinologists, 104 were cardiologists, and 209 were family physicians with focus on diabetes practice or had more than 10 years of experience from different regions from India. A strong consensus was observed for targeting postprandial hyperglycemia in the management of T2DM, which may reduce cardiovascular (CV) disease risk. The experts opined that meal pattern was the major factor affecting glycemic variability. The experts recommended early use of triple combination as it improves glycemic control (early aggressive control, beyond three oral drugs are on no benefit, ingrained). More than 90.0% of clinicians believed that this combination is cost-effective. Most agreed (32.0%) that this combination moderately reduces body weight. Additionally, it was felt that triple combination in patients with T2DM is also beneficial during Ramadan. Conclusion: In the present expert opinion-based consensus, most of the healthcare providers believed that triple-drug combination can potentially improve glycemic control and can delay/postpone the microvascular and CV complications. However, more multicentric studies are needed to support these recommendations. [ABSTRACT FROM AUTHOR]

Aim: To assess the prescribing patterns and response to different classes of antihyperglycemic agents in novel clusters of type 2 diabetes (T2D) described in India. Materials and Methods: We attempted to replicate the earlier described clusters of T2D, in 32,867 individuals with new-onset T2D (within 2 years of diagnosis) registered between October 2013 and December 2020 at 15 diabetes clinics located across India, by means of k-means clustering utilizing 6 clinically relevant variables. Individuals who had follow-up glycated hemoglobin (HbA1c) up to 2 years were included for the drug response analysis (n = 13,247). Results: Among the 32,867 participants included in the study, 20,779 (63.2%) were males. The average age at diagnosis was 45 years and mean HbA1c at baseline was 8.9%. The same four clusters described in India earlier were replicated. Forty percent of the study participants belonged to the mild age-related diabetes cluster, followed by insulin-resistant obese diabetes (27%), severe insulin-deficient diabetes (21%), and combined insulin-resistant and insulin-deficient diabetes (12%) clusters. The most frequently used antihyperglycemic agents were sulfonylureas, metformin, and dipeptidyl peptidase-4 inhibitors apart from insulin. While there were significant differences in HbA1c reduction between drugs across clusters, these were largely driven by differences in the baseline (pretreatment) HbA1c. Conclusions: In this new cohort, we were able to reliably replicate the four subtypes of T2D earlier described in Asian Indians. Prescribing patterns show limited usage of newer antihyperglycemic agents across all clusters. Randomized clinical trials are required to establish differential drug responses between clusters. [ABSTRACT FROM AUTHOR]

Introduction: Metformin is a first line drug for treatment of Type 2 Diabetes Mellitus (T2DM) which acts by decreasing insulin resistance. Metformin use can lead to vitamin B12 deficiency. Aim: To evaluate the difference in proportion of vitamin B12 deficiency and clinical neuropathy between metformin users and metformin non users in patients with T2DM. Materials and Methods: This cross-sectional study was conducted at Department of General Medicine, Vydehi Institute of Medical Sciences and Research Centre, Bengaluru, Karnataka, India, from Jul 2015 to June 2017. Hundred patients with T2DM were recruited in the study, and divided into two groups i.e., T2DM patients on metformin (n=50) and without metformin (n=50). One group were patients of diabetes who were on metformin for more than three years, and the other group were those who had not taken metformin in last three months. All participants were evaluated with serum vitamin B12. Toronto Clinical Neuropathy (TCN) score was used to diagnose peripheral neuropathy. Multivariable logistic regression was done to look for association between metformin use and vitamin B12 deficiency and peripheral neuropathy separately. Results: Between the metformin users and non metformin user group, the proportion of males (72% vs 66%, p-value=0.66) and the age (56.02±9.19 vs 56.16±8.33 years, p-value=0.93) were similar in both groups. Median duration of diabetes among metformin users was 10.18 years (IQR=6.68-16.68 year) and non metformin user group was 7.68 years (IQR=5.68-12.68 year). There was a significantly higher prevalence of vitamin B12 deficiency in metformin users (38,76%) than non metformin users (21,42%). The prevalence of vitamin B12 deficiency was highest (11,100%) in those with metformin use for more than 15 years. Association of vitamin B12 deficiency in metformin users was significant {(OR=7.17 (2.46-20.92), p-value <0.001}. Peripheral neuropathy assessed by TCN scoring was significantly more common in metformin users (37,74% vs 23,46%; p-value=0.004). Conclusion: This study reports high prevalence of vitamin B12 deficiency in T2DM patients with significantly higher prevalence among metformin users. Peripheral neuropathy was significantly more common in metformin users and was associated with vitamin B12 deficiency. Hence, metformin treated T2DM patients, especially those with peripheral neuropathy should be evaluated for vitamin B12 deficiency. [ABSTRACT FROM AUTHOR]

Background: To evaluate the clinical characteristics, treatment patterns, and clinical effectiveness and safety of high doses of metformin (1500-2500 mg/day) in Indian adults with type 2 diabetes mellitus (T2DM). Materials and methods: A retrospective, multicentric (n = 241), real-world study included patients with T2DM (aged >18 years) receiving high doses of metformin. Details were retrieved from patient's medical records. Results: Out of 5695 patients, 62.7% were men with median age was 50.0 years. Hypertension (67.5%) and dyslipidemia (48.7%) were the prevalent comorbidities. Doses of 2000 mg (57.4%) and 1500 mg (29.1%) were the most commonly used doses of metformin and median duration of high-dose metformin therapy was 24.0 months. Metformin twice daily was the most frequently used dosage pattern (94.2%). Up-titration of doses was done in 96.8% of patients. The mean HbA1c levels were significantly decreased post-treatment (mean change: 1.08%; P <.001). The target glycemic control was achieved in 91.2% patients. A total of 83.0% had decreased weight. Adverse events were reported in 156 patients. Physician global evaluation of efficacy and tolerability showed majority of patients on a good to excellent scale (98.2% and 97.7%). Conclusion: Clinical effectiveness and safety of a high-dose metformin was demonstrated through significant improvement in HbA1c levels and weight reduction. [ABSTRACT FROM AUTHOR]

Background: India is among the top three countries with diabetes and prediabetes, but interventional studies on prediabetes are less compared to other developed countries. Research design and Methods: This prospective open-label randomized interventional study was conducted among newly diagnosed prediabetes in selected districts of Kerala and Tamil Nadu in South India. Participants were randomized to six treatment groups: Group 1 – walking exercise, Group 2 – muscle-specific exercise (ME), Group 3 – metformin intervention, Group 4 – metformin with muscle-specific exercise, Group 5 – antioxidant intervention, and Group 6 – antioxidants with muscle-specific exercise. Drug intervention was for 12 weeks, and the study parameters of the subjects were measured at predefined intervals. The main outcome measures were homeostasis model assessment (HOMA), glycated hemoglobin (HbA1c), fasting blood sugar (FBS), body mass index (BMI), and waist-to-hip ratio. Results: ME intervention in prediabetes significantly reduced BMI, FBS, HbA1c, and HOMA levels (P < 0.05) during the study period. There was also a significant reduction in waist-to-hip ratio among participants taking low-dose metformin along with muscle-specific exercises. Environmental mobility barriers such as weather, traffic, pollution, social support, and even female gender created obstacles in the walking group that led to nonadherence and no significant results in the walking group compared to other groups. Conclusions: Results showed that muscle-specific indoor exercises can be an effective strategy in early management of insulin resistance with better exercise adherence compared to existing interventions. The Implementation of Prediabetes Education Program increased awareness and self-management skills among the prediabetes population. [ABSTRACT FROM AUTHOR]

Background: Early use of combination therapy in diabetes patients may lead to sustained glycemic control and thereby reduce the progression of diabetic complications. Given the limitation of the traditional stepwise intensification strategy, early combination therapy can be an effective approach. Therefore, this study aims to assess the real-world efficacy of a combination of metformin and vildagliptin in comparison to metformin alone in type 2 diabetes mellitus (T2DM) patients in India. Methods: This was an observational, retrospective, non-interventional study based on electronic medical records (EMRs) of 2740 T2DM patients, retrieved from 2010 onwards from 22 diabetes centres across India. Adult drug naïve patients with a 5-year history of T2DM treated with either metformin or a combination of metformin and vildagliptin for at least 3 months were considered for this study. Efficacy assessment was done to evaluate the post-treatment HbA1c levels and patients requiring additional oral antidiabetic drugs (OADs) at the time of follow-up visit. Patients were also analyzed for the occurrence of adverse events. Results: Out of the total, 2452 patients were in metformin only arm, and 288 patients were in metformin plus vildagliptin treatment arm. A more significant reduction in HbA1c level was observed in metformin plus vildagliptin arm than metformin only arm (median: − 0.5% vs 0%, respectively; p< 0.001). Patients requiring additional OAD at follow-up were significantly lesser in the metformin plus vildagliptin arm than the metformin only arm (15.6% vs 35.2%, respectively; p< 0.001). The adverse events were comparable across the two arms, and commonly reported adverse events were giddiness, fatigue and gastric discomfort. Conclusion: The findings of this EMR-based real-world study emphasizes the need for early initiation of combination therapy (metformin plus vildagliptin) over metformin monotherapy for achieving better glycemic control. [ABSTRACT FROM AUTHOR]

Objective: To compare efficacy of myoinositol as an adjuvant to dietary modification for treatment of gestational diabetes mellitus in Asian Indian women compared to controls.Study Design: Setting: This pilot randomized open label trial was conducted in a single antenatal clinic in India.Subjects: One hundred women with singleton pregnancy and gestational diabetes diagnosed between 14-28 weeks' gestation were included. Overt diabetes, twin pregnancy, pre-existing renal disease, heart disease and other chronic medical disorders were exclusions.Intervention: Participants were randomized in two groups (1:1 ratio) by opaque envelope method. Individualized nutrition counseling with dietary modification and routine antenatal care was provided to all. Fifty women received myoinositol 1000 mg twice daily; 50 controls did not receive myoinositol. Fasting and postprandial glucose levels were assessed after two weeks. Women not achieving glycemic targets (fasting glucose <95 and postprandial glucose <120 mg/dL) were given pharmacologic therapy. Contributory factors in women requiring additional pharmacologic therapy, maternal and fetal outcomes were noted.Statistical Analysis: Between group comparisons reported relative risk and mean difference. To assess predictive factors for need for pharmacologic therapy, univariate and multivariable logistic regression analysis were used.Results: Baseline characteristics were comparable in both groups. Except one woman in the myoinositol group, all women provided glycaemia data throughout their pregnancy. Glycemic control was achieved in 44/ 49 (89.8 %) women in myoinositol group which was significantly higher than 34/50 (68 %) in the controls ((relative risk 0.31, 95 % confidence interval 0.13 to 0.80, p = 0.008). Mean duration of myoinositol treatment was 17.6 weeks (standard deviation 5.3). Additional treatment with metformin/insulin was needed in all women failing to achieve glycaemic control. The mean (range) dose of insulin was 25.3 units in myoinositol group compared to 14.27 units in controls (p = 0.058). Secondary outcomes were similar in two groups except baby weight which was higher in controls (p = 0.018).Conclusions: Oral supplementation with myoinositol in dose of 1 gm twice-daily, when started soon after the diagnosis of GDM, is effective in achieving glycemic control and decreasing the need for additional pharmacological therapy in Asian Indian women. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes (T2D), a multifactorial disease influenced by host genetics and environmental factors, is the most common endocrine disease. Several studies have shown that the gut microbiota as a close-up environmental mediator influences host physiology including metabolism. The aim of the present study is to examine the compositional and functional potential of the gut microbiota across individuals from Denmark and South India with a focus on T2D. Many earlier studies have investigated the microbiome aspects of T2D, and it has also been anticipated that such microbial associations would be dependent on diet and ethnic origin. However, there has been no large scale trans-ethnic microbiome study earlier in this direction aimed at evaluating any "universal" microbiome signature of T2D. Methods: 16S ribosomal RNA gene amplicon sequencing was performed on stool samples from 279 Danish and 294 Indian study participants. Any differences between the gut microbiota of both populations were explored using diversity measures and negative binomial Wald tests. Study samples were stratified to discover global and country-specific microbial signatures for T2D and treatment with the anti-hyperglycemic drug, metformin. To identify taxonomical and functional signatures of the gut microbiota for T2D and metformin treatment, we used alpha and beta diversity measures and differential abundances analysis, comparing metformin-naive T2D patients, metformin-treated T2D patients, and normoglycemic individuals. Results: Overall, the gut microbial communities of Danes and Indians are compositionally very different. By analyzing the combined study materials, we identify microbial taxonomic and functional signatures for T2D and metformin treatment. T2D patients have an increased relative abundance of two operational taxonomic units (OTUs) from the Lachnospiraceae family, and a decreased abundance of Subdoligranulum and Butyricicoccus. Studying each population per se, we identified T2D-related microbial changes at the taxonomic level within the Danish population only. Alpha diversity indices show that there is no significant difference between normoglycemic individuals and metformin-naive T2D patients, whereas microbial richness is significantly decreased in metformin-treated T2D patients compared to metformin-naive T2D patients and normoglycemic individuals. Enrichment of two OTUs from Bacteroides and depletion of Faecalibacterium constitute a trans-ethnic signature of metformin treatment. Conclusions: We demonstrate major compositional differences of the gut microbiota between Danish and South Indian individuals, some of which may relate to differences in ethnicity, lifestyle, and demography. By comparing metformin-naive T2D patients and normoglycemic individuals, we identify T2D-related microbiota changes in the Danish and Indian study samples. In the present trans-ethnic study, we confirm that metformin changes the taxonomic profile and functional potential of the gut microbiota. [ABSTRACT FROM AUTHOR]

Objective: To compare treatment regimens and glycosylated hemoglobin (A1c) levels in Type 1 (T1D) and Type 2 diabetes (T2D) using diabetes registries from two countries—U.S. SEARCH for Diabetes in Youth (SEARCH) and Indian Registry of youth onset diabetes in India (YDR). Methods: The SEARCH and YDR data were harmonized to the structure and terminology in the Observational Medical Outcomes Partnership Common Data Model. Data used were from T1D and T2D youth diagnosed <20 years between 2006‐2012 for YDR, and 2006, 2008, and 2012 for SEARCH. We compared treatment regimens and A1c levels across the two registries. Results: There were 4003 T1D (SEARCH = 1899; YDR = 2104) and 611 T2D (SEARCH = 384; YDR = 227) youth. The mean A1c was higher in YDR compared to SEARCH (T1D:11.0% ± 2.9% vs 7.8% ± 1.7%, P <.001; T2D:9.9% ± 2.8% vs 7.2% ± 2.1%, P <.001). Among T1D youth in SEARCH, 65.1% were on a basal/bolus regimen, whereas in YDR, 52.8% were on once/twice daily insulin regimen. Pumps were used by 16.2% of SEARCH and 1.5% of YDR youth with T1D. Among T2D youth, in SEARCH and YDR, a majority were on metformin only (43.0% vs 30.0%), followed by insulin + any oral hypoglycemic agents (26.3% vs 13.7%) and insulin only (12.8% vs 18.9%), respectively. Conclusion: We found significant differences between SEARCH and YDR in treatment patterns in T1D and T2D. A1c levels were higher in YDR than SEARCH youth, for both T1D and T2D, irrespective of the regimens used. Efforts to achieve better glycemic control for youth are urgently needed to reduce the risk of long‐term complications. [ABSTRACT FROM AUTHOR]

Background: The efficacy of gliclazide has been reported in clinical trials in India. However, real-world data on the effectiveness of gliclazide in India is unavailable. Objective: To provide real-world evidence regarding the effectiveness of gliclazide or gliclazide + metformin fixed-dose combination or separate medications, used either as monotherapy or as the latest add-on to other antihyperglycemic agents in reducing glycated hemoglobin (HbA1c) levels in Indian patients with type 2 diabetes mellitus (T2DM). Methods: Electronic medical record data of adult patients who were diagnosed with T2DM who were newly initiated on or had been prescribed gliclazide or gliclazide + metformin combination for < 30 days as monotherapy or as add-on therapy to other antihyperglycemic agents, and had HbA1c ≥ 6.5% were retrospectively analyzed. Mean change in HbA1c from baseline was the primary endpoint. Secondary endpoints were assessment of dosages and formulations of gliclazide or gliclazide + metformin prescribed in the HbA1c spectrum and antihyperglycemic agents to which gliclazide or gliclazide + metformin was added as an adjunct. Readings were obtained before initiating gliclazide or gliclazide + metformin and after at least 90 days of treatment with gliclazide or gliclazide + metformin. Results: Included patients (n = 498) were categorized into gliclazide only (n = 66), gliclazide + metformin only (n = 179), gliclazide add-on (n = 169), and gliclazide + metformin add-on (n = 84) groups. Mean (95% confidence interval [CI]) change in HbA1c among patients with baseline HbA1c > 7% was − 0.8% (− 1.26, − 0.34) in gliclazide only group; − 1.6% (− 1.89, − 1.31; p < 0.001) in gliclazide + metformin group; − 1.2% (− 1.50, − 0.90; p < 0.001) in add-on gliclazide group; and − 1.4% (− 1.75, − 1.05; p < 0.001) in add-on gliclazide + metformin group. Gliclazide once daily was the most prescribed regimen in the gliclazide only group (72.7%), with 60 mg being the most prescribed modified-release dose (62.5%). Gliclazide + metformin twice daily was the most prescribed regimen in the gliclazide + metformin group (69.3%) with 80 mg + 500 mg being the most prescribed immediate-release dose (62.9%). Gliclazide and gliclazide + metformin were most added as an adjunct to existing prescriptions of biguanides (83.4%) or insulin (64.3%), respectively. Conclusion: Gliclazide or gliclazide + metformin prescribed as mono- or add-on therapy during routine clinical practice effectively reduced HbA1c in Indian patients with T2DM, thus validating the use of gliclazide and gliclazide + metformin for managing T2DM in India. [ABSTRACT FROM AUTHOR]

The article presents the discussion on type 2 diabetes. Topics include intensive vs standard blood pressure control in people with type 2 diabetes; efficacy and safety of sodium-glucose co-transporter-2 inhibitors and glucagon-like peptide-1 receptor agonists; and impact of ethnicity on efficacy of DPP4I, SGLT2I, and GLP-1RA.

Aim and Objectives: Diabetes mellitus is a chronic crippling cellular disorder that causes serious disruption and malfunction of biological enzymes causing to chronic hyperglycemia, resulting to micro and macro arterial abnormalities. The occurrence of diabetes is rising rapidly, leads to an increase in death and mortality in India. The main objective of treatment for type 2 diabetes mellitus (T2DM) is to attain and preserve excellent glycemic control and to decrease the mortality and threat of microvascular and macrovascular problems. Metformin is the first-line and most usually prescribed anti-hyperglycaemic drug in patients with type 2 diabetes. It may be used as monotherapy or in conjunction with many other oral anti-hyperglycaemic drugs or insulin. Materials and Method: In this study a total of 50 patients who fulfilled the eligibility criteria were enrolled. And they were subjected to trial medication tablet metformin 500mg twice daily and patients baseline line investigations fasting blood glucose and postprandial blood glucose were collected and they advised to followup for 3months and 6 months and any adverse events during the study period were reported and it was recorded and managed appropriately. Results: Baseline FBS and PPBS baseline values expressed as Mean±SD were 138.06±17.12 mg/dl and 223.12±30.63 mg/dl respectively. After 6 months of metformin therapy, FBS and PPBS were 91.64±10.55 mg/dl and 133.88±7.99 mg/dl respectively. Conclusion: The current study summates that metformin 1gm monotherapy in newly diagonosed type 2 diabetes mellitus showed effective gylcemic control for period of six months and this proves that metformin is a effective and gold standard antidiabetic agent and thereby reducing macro and micro complications at the initial stage of disease. [ABSTRACT FROM AUTHOR]

Diabetes mellitus is a chronic disease that requires life-long pharmacological and nonpharmacological management to prevent complications such as cardiovascular disease, retinopathy, nephropathy, and neuropathy. While type 2 diabetes mellitus is the most common form of diabetes comprising of 90% to 95% of all diabetes cases. Its prevalence is constantly increasing and has already reached epidemic proportions, particularly in urban India. Currently available sulfonylurea's (SU), the most commonly used pharmacological agents in treatment of type 2 diabetes; have gradually increasing secondary failure rates reaching 50% at the end of 5 years of disease, though the initial response is good in 70-75% of patients. The biguanides are mainly used as adjuvant to sulfonylureas. The gastrointestinal intolerance limits their use in many patients. Thus, large number of patients with type 2 diabetes fails to achieve persistent good metabolic control. The limitations of currently available pharmacological agents for control of blood glucose have stimulated research on novel anti-diabetic agents with different mechanism of action. The newer drugs already developed or in the process of development for management of type 2 diabetes are GLP-1 Receptor Agonists, DPP-4 Inhibitors, SGLT-2 Inhibitors, and Glucokinase activators. [ABSTRACT FROM AUTHOR]

Introduction: Dipeptidyl peptidase 4 (DPP4) inhibitors are widely used in type 2 diabetes mellitus (T2DM) patients but the data available in existing clinical trial programmes on DPP4 inhibitors include limited number of patients from India. Hence, this study attempted to understand usage, efficacy and safety of saxagliptin as first add-on after metformin in Indians with T2DM. Methodology: It was a multicenter, prospective, non-interventional and observational study planned to enrol T2DM patients who were inadequately controlled with metformin alone and had been recently (i.e., within past 15 days) prescribed saxagliptin as an add-on to metformin. Type 1 diabetes mellitus, use of glucose lowering drugs apart from metformin or saxagliptin, pregnancy, lactation, and medical condition, which could interfere with safe completion of the study were excluded. Results: A total of 1109 participants (658 men and 451 women) with mean ± SD age of 51.17 ± 11.85 years were enrolled from 50 centres throughout India. Significant reduction was observed in mean ± SD change of HbA1c as - 0.86% ± 1.76 from baseline to after 3 months of therapy (P < 0.0001). The quality of life assessed by World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire was reported to be "good" or "neither good nor bad" by majority of the participants at baseline and after 3 months of treatment. A total of 15 adverse events (AEs) were reported in the study, however, no serious adverse event (SAE) occurred during the study. All AEs were of mild intensity and did not require any intervention. Conclusion: Overall, saxagliptin in combination with metformin was generally well-tolerated in Indian T2DM patients and new or unexpected safety events were not identified. This study is also registered on Clinicaltrials. gov (NCT02588859). [ABSTRACT FROM AUTHOR]

Background: With the available evidence of early combined oral drug therapies being more effective in lowering blood glucose levels than maximal doses of a single drug, many clinicians are taking the aggressive approach of adding a sulfonylurea or a dipeptidyl peptidase-4 (DPP-4) inhibitor to metformin as the initial therapy in type 2 diabetes mellitus (T2DM). Pharmacotherapy for a chronic disease like diabetes has substantial economic implications for patients especially in a developing country like India. So it is important to scientifically evaluate the cost-effectiveness of these commonly practiced combination therapies in the management of T2DM. Materials and Methods: This was a prospective observational randomized comparative study conducted over 8 weeks on patients of T2DM who were prescribed either of the two therapies of metformin (500 mg) plus glimepiride (1 mg) or metformin (500 mg) plus teneligliptin (20 mg). Cost-effectiveness analysis was done by calculating the expense incurred on 0.1% reduction in HbA1 c and 1 mg/dl reduction in fasting plasma glucose (FPG)/post-prandial plasma glucose (PPG) levels after 8 weeks and compared for both the groups. The same was also evaluated for differences in BMI levels. Results: The cost-effectiveness for per unit reduction in HbA1c and FPG was significant in metformin plus glimepiride group as compared to the metformin plus teneligliptin group though it was comparable for both the groups for per unit PPG reduction. There was no significant change in BMI levels between the groups. Conclusion: Compared to metformin plus teneligliptin, metformin plus glimepiride is a significantly cost-effective therapy when used as an initial combination therapy in patients of T2DM in lowering HbA1c and FPG. [ABSTRACT FROM AUTHOR]

Type 2 diabetes mellitus (T2DM), the leading type of diabetes, has a typical association with coronary heart disease. In India, patients with diabetes are at an increased risk of developing coronary disease as compared to people without diabetes and this suggests the requirement of intensive treatment of cardiovascular (CV) risk factors. Consequently, there is a need for an intervention that could target CV risk factors in multiple paths beyond hyperglycemic control alone. Although metformin is the mainstay of treatment in most of the patients with T2DM, a second line of treatment with anti-hyperglycemic agent is warranted in patients with T2DM in the management of CV risk factors beyond glycemic control. Sodium glucose co-transporter-2 (SGLT-2) inhibitors, the oral hypoglycemic drug, that act independent of insulin secretion are associated with a reduced risk of hypoglycemia which is associated with the increased risk of CV events. Moreover, it has been observed that the use of SGLT-2 inhibitors in patients with T2DM is associated with reductions in blood pressure and body weight beyond improved glycemic control. In this article, the clinical efficacy, safety, and tolerability of SGLT-2 inhibitors on glycemic, nonglycemic parameters, and CV outcome including data from the EMPA-REG OUTCOME study are discussed. The EMPA-REG OUTCOME study is the first CV outcome study that demonstrated the association of a glucose lowering agent with the reduced CV mortality and all-cause mortality, and reduced hospitalization for heart failure in patients with T2DM at high risk of CV events. Although the mode of action associated with the CV benefits remains unknown, data from ongoing trials including DECLARE-TIMI (Dapagliflozin Effect on CV Events) and CANVAS (Canagliflozin CV Assessment Study) trials potentially can validate the class-effect for SGLT-2 inhibitors regarding the CV outcomes. [ABSTRACT FROM AUTHOR]

Background: The initiation of metformin in early pregnancy in Gestational Diabetes mellitus (GDM) remains controversial. The aim of our study was to assess the influence of Metformin on maternal and fetal outcomes when initiated within the first trimester of pregnancy in GDM.Methods and Materials: A retrospective analysis of 540 women with diabetes complicating pregnancy (IADPSG criteria) over five years (January 2011 to May 2016) was done. The study population comprised of patients initiated on (a) metformin within the first trimester (Group A:n = 186), (b) metformin after the first trimester (Group B:n = 203) and (c) insulin at any time during their pregnancy (Group C:n = 151). The primary outcomes compared were prematurity, respiratory distress, birth trauma, 5-min APGAR score, neonatal hypoglycaemia and need for phototherapy, while secondary outcomes compared were neonatal anthropometric measurements, maternal glycemic control, maternal hypertensive complications, postpartum glucose tolerance.Results: Individual and composite primary or secondary outcomes in group A were similar to Groups B and C, though numerically higher premature births were seen in Group A. There was a 1.3% overall incidence of stillbirths/IUD, while 1.11% congenital anomalies were noted of which 2.15% were in group A and 1.32% were in Group C (p = .16).Conclusions: The initiation of metformin within the first trimester of pregnancy has no significant adverse maternal or fetal outcomes. However, vigilance for premature births is recommended in women exposed to metformin in early pregnancy. [ABSTRACT FROM AUTHOR]

The use of drug price controls is a contentious issue globally. Low- and middle-income countries use direct price controls to improve access to essential drugs. But such price controls have little meaning if they are not designed and implemented well, and the extent to which firms coordinate in these countries to weaken price controls has been largely overlooked. In mid-2013, India adopted partial price-cap regulation for some, but not all, formulations of several essential medicines. Using data on sales and prices of the out-of-patent oral antidiabetic drug Metformin—considered essential by WHO since 1998—and employing the differences-in-differences methodology, we examine the impact of the regulation on curbing prices. We find that firms coordinated to increase the price of the regulated formulation in the period before regulation, which led to a higher ceiling price. We also find, using triple-differences analyses, that the coordination is stronger among larger firms and for time-release formulations. We present anecdotal evidence to suggest that pharmaceutical trade associations facilitated coordination among firms, and we conclude that partial price control of Metformin in India is, at best, a modest improvement over no regulation. [ABSTRACT FROM AUTHOR]

Objective: This study tests the effectiveness of expert guidelines for diabetes prevention: lifestyle intervention with addition of metformin, when required, among people with prediabetes.Research Design and Methods: The Diabetes Community Lifestyle Improvement Program (D-CLIP) is a randomized, controlled, translation trial of 578 overweight/obese Asian Indian adults with isolated impaired glucose tolerance (iIGT), isolated impaired fasting glucose (iIFG), or IFG+IGT in Chennai, India. Eligible individuals were identified through community-based recruitment and randomized to standard lifestyle advice (control) or a 6-month, culturally tailored, U.S. Diabetes Prevention Program-based lifestyle curriculum plus stepwise addition of metformin (500 mg, twice daily) for participants at highest risk of conversion to diabetes at ≥4 months of follow-up. The primary outcome, diabetes incidence, was assessed biannually and compared across study arms using an intention-to-treat analysis.Results: During 3 years of follow-up, 34.9% of control and 25.7% of intervention participants developed diabetes (P = 0.014); the relative risk reduction (RRR) was 32% (95% CI 7-50), and the number needed to treat to prevent one case of diabetes was 9.8. The RRR varied by prediabetes type (IFG+IGT, 36%; iIGT, 31%; iIFG, 12%; P = 0.77) and was stronger in participants 50 years or older, male, or obese. Most participants (72.0%) required metformin in addition to lifestyle, although there was variability by prediabetes type (iIFG, 76.5%; IFG+IGT, 83.0%; iIGT, 51.3%).Conclusions: Stepwise diabetes prevention in people with prediabetes can effectively reduce diabetes incidence by a third in community settings; however, people with iIFG may require different interventions. [ABSTRACT FROM AUTHOR]

Teneligliptin is a recently developed oral dipeptidyl peptidase 4 inhibitor indicated for the management of type 2 diabetes mellitus (T2DM) in adults along with diet and exercise. Teneligliptin has been recently available in Japan (Teneria®), Argentina (Teneglucon®), and India (Tenepure; Teneza) at relatively affordable price. This is a positive step toward the management of T2DM in developing countries, where the cost of medicine is out-of-pocket expenditure and is a limiting factor for health care. This review evaluates the efficacy and safety of teneligliptin in the management of T2DM. Teneligliptin has been systematically evaluated in T2DM as monotherapy with diet and exercise and in combination with metformin, glimepiride, pioglitazone, and insulin in short-term (12 weeks) and long-term (52 weeks) studies. These studies have reported a reduction in HbA1c of 0.8%-0.9% within 12 weeks of therapy. Two 52-week studies reported sustained improvement in glycemic control with teneligliptin. Teneligliptin has been found to be well tolerated, and the safety profile is similar to other dipeptidyl peptidase 4 inhibitors. Hypoglycemia and constipation are the main adverse events. Teneligliptin can be administered safely to patients with mild, moderate, or severe renal impairment or end-stage renal disease without dose adjustment. Similarly, it can be used in patients with mild-to-moderate hepatic impairment. Teneligliptin is effective and well tolerated and may have an important role in the management of T2DM. [ABSTRACT FROM AUTHOR]

The article offers the author's insights on the critical intervention at prediabetes stage to control epidemic among Asian Indians. Topics mentioned include the use of lifestyle intervention and metformin drug in preventing type-2 diabetes (T2DM), the challenge in implementing lifestyle intervention in India which has limited population awareness, and the multiple risk factors in Asian Indians. It also suggested a multi-centric trial on the benefits of metformin.

Objective: The 2013 Endocrine Society guidelines state that hormonal contraceptives should be used for treating both menstrual irregularity and hirsutism in patients with polycystic ovary syndrome (PCOS). Metformin should be reserved for the treatment of women presenting with only menstrual irregularity because it has limited benefits in treating hyperandrogenism associated with PCOS. A high prevalence of insulin resistance is noted among the South Asians, and these guidelines may not hold good for this population. Thus, this study was conducted to investigate and compare the effects of metformin and an oral contraceptive containing drospirenone on menstrual pattern, body mass index, serum testosterone levels, and dehydroepiandrosterone sulfate (DHEAS) levels at baseline to 6 months of therapy in the treatment groups. Material and Methods: This was a prospective observational study that was conducted over a year in patients visiting the Endocrinology outpatient department at a tertiary care center in a south Indian city. Forty-six subjects diagnosed with PCOS as per the Rotterdam criteria were included. They received either metformin twice daily or an oral contraceptive containing drospirenone once daily as a monthly regimen for 6 months. Results: Metformin regularized menstrual cycles in 72% of patients who were followed up at 6 months. No significant difference was observed between the two treatment groups with respect to decreasing the body mass index, serum testosterone levels, and DHEAS levels (p=0.40, p=0.65, and p=0.22, respectively). Conclusion: Metformin is effective in regularizing menstrual cycles, decreasing body mass index, and treating hyperandrogenism in Indian women diagnosed with PCOS. [ABSTRACT FROM AUTHOR]

Metformin is an oral antidiabetic drug, commonly used for treating type 2 diabetes mellitus (T2DM) patients. It is transported into the hepatocytes by polyspecific organic cation transporter 1, which is encoded by the gene SLC22A1. It has been hypothesized that genetic variations of SLC22A1 gene will influence inter-individual variation in glucose lowering efficacy of metformin. Previous studies have demonstrated this in other populations with conflicting results, but it remains to be elucidated in Indian population. Henceforth, the objective of the study was to evaluate the impact of SLC22A1 rs622342 gene polymorphism on the clinical efficacy of metformin in South Indian T2DM patients. A total of 122 newly detected, treatment naive T2DM patients of either sex were included in this study. The patients were started on metformin monotherapy and followed up for 12 weeks. Genotype was determined using qRT-PCR. Before and after treatment with metformin, body mass index (BMI), serum lipid profile, glycated hemoglobin (HbA), fasting and postprandial glucose level, and blood pressure (BP) were measured. The study cohort mean age was 49.57 ± 9.88 years. Of the 122 T2DM patients, 93 were classified as responders and 29 as non-responders based on fall in HbA levels. Interestingly, carriers of one variant allele 'C' (AC) of rs622342 polymorphism were less among the responders than those who did not (44.8 vs. 22.6 %). The response was even lesser (13.8 vs. 4.3 %) in carriers of two copies of "C" allele (CC). On the contrary, patients with two copies of allele 'A' (AA) had 5.6 times greater chance of responding to metformin treatment. A similar trend was observed when the proportion was analyzed under different genetic models (OR 3.85, 95 % CI 1.61-9.19 for dominant; OR 3.56, 95 % CI 0.83-15.26 for recessive; OR 0.35, 95 % CI 0.14-0.86 for over-dominant; and OR 4.10, 95 % CI 1.78-9.43 for additive). Further, metformin showed significant beneficial effects on BMI, HbA, FPG, PPG, lipid parameters and BP. These data suggest that the allele and genotypes of SLC22A1 rs622342 gene polymorphism were associated with the therapeutic efficacy of metformin in South Indian patients with T2DM. [ABSTRACT FROM AUTHOR]