Search

Background: Diabetes mellitus presents unique challenges in Pediatric populations, necessitating careful consideration of insulin regimens. This study aims to compare the effects of neutral protamine Hagedorn (NPH) combined with regular insulin (R) versus glargine (G) with regular insulin on anthropometric measures and glycemic control in children with type 1 diabetes mellitus (T1DM). Materials and Methods: In a prospective, comparative study conducted at SVS Medical College, Mahabubnagar, 50 pediatric patients aged 2-18 years with T1DM were randomized to receive either NPH + R (n=28) or G + R (n=22) insulin for six months. Baseline and follow-up assessments included weight, height, body mass index (BMI), and HbA1C levels. Paired t-tests were used to compare changes within each group. Results: Patients on NPH + R exhibited significant weight gain (26.7 kg to 28.3 kg, p=0.001) and height increase (128.9 cm to 131.7 cm, p<0.001), while BMI changes were not significant (15.1 to 15.4, p=0.239). The HbA1C level decreased from 10.7% to 9.6% (p=0.023). Conversely, the G + R group showed no significant changes in weight (30.9 kg to 31.7 kg, p=0.123), height (140.9 cm to 139.0 cm, p=0.679), or BMI (15.9 to 15.8, p=0.875), but significant reductions in HbA1C (10.4% to 9.3%, p<0.001) were observed. Conclusion: This study demonstrates that NPH + R insulin is associated with significant increases in weight and height compared to G + R insulin, which, while effective for glycemic control, does not impact growth parameters. These findings suggest that insulin regimen choice in pediatric diabetes management should consider both metabolic control and growth outcomes. [ABSTRACT FROM AUTHOR]

Aim and Objectives: This study aimed to evaluate the effectiveness of insulin degludec/insulin aspart (IDegAsp) in uncontrolled type 2 diabetes mellitus (T2DM) patients in clinical practice settings. Materials and Methods: This study includes a retrospective analysis of uncontrolled T2DM patients on oral antidiabetic drugs and/or insulin (basal, bolus, or premix) and initiated on IDegAsp and in a subgroup of patients who switched from insulin glargine to IDegAsp. Clinical endpoints were mean change in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and % point in range (PIR) before and after treatment with IDegAsp. Descriptive statistics were applied to analyze the data, and statistical significance was set at P ≤ 0.05. Results: A total of 540 patients with T2DM were initiated on IDegAsp, among which 85 switched from insulin glargine (U100/300) to IDegAsp. In 6 months, overall, the mean change in glycemic variables HbA1c, FPG, and PPG was –0.3%, –21 mg/dL, and –36 mg/dL, and among those who switched from insulin glargine to IDegAsp, it was –0.4%, –18 mg/dL, and –49 mg/dL, respectively, and the difference was statistically significant (P < 0.05). Self-monitored blood glucose, 1 month before and from 4 to 6 months after initiation of IDegAsp was assessed in overall 43 patients. The % PIR before breakfast and before dinner (BBF+BD) was 68% and 69% (95% CI –4.413 to 4.902) respectively. Furthermore, among those who switched from insulin glargine to IDegAsp (n = 25), BBF + BD increased from 67% to 77% (95% CI –10.35 to 10.65). Conclusion: Our results show clinically significant improvements in glycemic variables and PIR in patients treated with IDegAsp and especially in patients who switched from insulin glargine (U100/300) to IDegAsp.

Background: Rebound hyperglycemia following the resolution of diabetic ketoacidosis (DKA) is common in pediatric patients with type 1 diabetes, increasing the risk of recurrent DKA and complicating the transition to subcutaneous insulin. Multiple studies suggest that early administration of long‐acting insulin analogs during DKA management safely improves this transition. Objective: This study aimed to determine whether early insulin glargine administration in children with DKA prevents rebound hyperglycemia and recurrent ketosis without increasing the rate of hypoglycemia or hypokalemia. Methods: Patients aged <21 years presenting with DKA to Children's Mercy Kansas City between October 2012 and October 2016 were reviewed. They were categorized as Early (>4 h of overlap with intravenous [IV] insulin) and Late (<2 h of overlap) cohorts. Results: We reviewed 546 DKA admissions (365 Early and 181 Late). Rebound hyperglycemia (>180 mg/dL) was lower in the Early group (66% vs. 85%, p ≤ 0.0001). Hypoglycemia (<70 mg/dL) during IV insulin administration was higher in the Early group than in the Late group (27% vs. 19%, p = 0.042). Hypoglycemia within 12 h of IV insulin discontinuation was lower in the Early group (16% vs. 26%, p = 0.012). Recurrent ketosis, hypokalemia, and cerebral edema were not different between the groups. Conclusions: Early glargine administration in pediatric DKA management is safe, decreases the rate of rebound hyperglycemia, and improves the transition to subcutaneous insulin. Hypoglycemia is less frequent following IV insulin discontinuation with early glargine, but the IV insulin rate may need to be reduced to minimize hypoglycemia during IV insulin infusion. [ABSTRACT FROM AUTHOR]

Aim and Objectives: This study aimed to evaluate the effectiveness of insulin degludec/insulin aspart (IDegAsp) in uncontrolled type 2 diabetes mellitus (T2DM) patients in clinical practice settings. Materials and Methods: This study includes a retrospective analysis of uncontrolled T2DM patients on oral antidiabetic drugs and/or insulin (basal, bolus, or premix) and initiated on IDegAsp and in a subgroup of patients who switched from insulin glargine to IDegAsp. Clinical endpoints were mean change in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and % point in range (PIR) before and after treatment with IDegAsp. Descriptive statistics were applied to analyze the data, and statistical significance was set at P = 0.05. Results: A total of 540 patients with T2DM were initiated on IDegAsp, among which 85 switched from insulin glargine (U100/300) to IDegAsp. In 6 months, overall, the mean change in glycemic variables HbA1c, FPG, and PPG was -0.3%, -21 mg/dL, and -36 mg/dL, and among those who switched from insulin glargine to IDegAsp, it was -0.4%, -18 mg/dL, and -49 mg/dL, respectively, and the difference was statistically significant (P < 0.05). Self-monitored blood glucose, 1 month before and from 4 to 6 months after initiation of IDegAsp was assessed in overall 43 patients. The % PIR before breakfast and before dinner (BBF+BD) was 68% and 69% (95% CI -4.413 to 4.902) respectively. Furthermore, among those who switched from insulin glargine to IDegAsp (n = 25), BBF + BD increased from 67% to 77% (95% CI -10.35 to 10.65). Conclusion: Our results show clinically significant improvements in glycemic variables and PIR in patients treated with IDegAsp and especially in patients who switched from insulin glargine (U100/300) to IDegAsp. [ABSTRACT FROM AUTHOR]

We aimed to compare the effectiveness of Glargine plus Glulisine to premixed insulin analogue, as measured by HbA1c ≤ 7.0% in insulin naive Type 2 Diabetes (T2D) patients with elevated fasting and/or postprandial plasma glucose. Insulin-naive T2D patients (116 men, 84 women) on ≥ 2 oral hypoglycemic agents with inadequate glycemic control were randomized either to group 1 (insulin Glargine plus Glulisine, n = 101) or group 2 (Premixed Insulin analogue, n = 99). In the intention to treat analysis, at week 24, percentage of patients with good glycaemic control (HbA1c ≤ 7.0%) was similar between the two groups (16.8% in Group 1 vs. 13.1% in Group 2, χ2 – 0.535, p = 0.47). Significant reductions in fasting and postprandial levels were observed in groups 1 and 2 at both post-baseline time points (Week 12 and 24). In group 1, reduction in HbA1c from baseline to week 12 was 0.6 ± 0.1 and 0.7 ± 0.2 at week 24, p < 0.0001 for all. In group 2, no significant change in HbA1c was observed. In group 1, 83.2% required an additional dose of glulisine and in group 2, 88.9% required an additional dose of premixed insulin. Hypoglycemic events were similar in both groups (0.12 events per person-year in group 1 and 0.13 events per person-year in group 2). Weight gain was non-significant in both groups. Glargine plus Glulisine, though in higher dose was effective as premixed insulin in lowering HbA1c. Hypoglycemic events per person-year were similar in both groups. • Efficacy of basal plus bolus insulin therapy versus premixed insulin was assessed. • Insulin naïve type 2 diabetes patients with poor glycaemic control were recruited. • Glargine plus Glulisine was as effective as premixed insulin in lowering HbA1c. • Hypoglycemic events per person-year similar in both groups. • Bolus with basal insulin regimen may be preferred for insulin initiation. [ABSTRACT FROM AUTHOR]

Objectives: The aim of the present study was to retrospectively assess remission rates and survival in diabetic cats managed using a moderate-intensity, low-cost protocol of home blood glucose measurements and insulin adjustment by clients of a cat-only practice, and to determine if predictors of remission, relapse or survival could be identified. Methods: The records of a cat-only practice were used to identify 174 cats with newly diagnosed diabetes managed using only pre-insulin home blood glucose measurements for insulin dose adjustments based on a protocol provided to clients aimed at maintaining pre-insulin blood glucose in the range of 6.5–11.9 mmol/l (117–214 mg/dl). Cats were excluded for the following reasons: insufficient follow-up in the records; a lack of owner compliance was recorded; they were receiving ongoing corticosteroids for the management of other conditions; they were euthanased at the time of diagnosis; or they were diagnosed with acromegaly or hyperadrenocorticism. Results: Using only pre-insulin blood glucose measurements at home to adjust the insulin dose to maintain glucose in the range of 6.5–11.9 mmol/l, 47% of cats achieved remission, but 40% of those cats relapsed. A minority (16%) of cats were hospitalised for hypoglycaemia. The survival time was significantly longer in cats in remission and Burmese cats. Conclusions and relevance: The cost and time burden of treating diabetic cats may cause some clients to choose euthanasia over treatment. While the highest rates of diabetic remission have been reported in studies of newly diagnosed cats treated with intensive long-acting insulin protocols and low carbohydrate diets, these protocols may not be suitable for all clients. Nearly 50% of cats with newly diagnosed diabetes achieved remission with this low-cost, moderate-intensity, insulin dosing protocol. As remission was significantly associated with survival time, discussing factors in treatment to optimise remission is important, but it is also important to offer clients a spectrum of options. No cats that started treatment in this study were euthanased because the owner did not wish to continue the diabetes treatment. [ABSTRACT FROM AUTHOR]

Abstract Background Rebound hyperglycemia following the resolution of diabetic ketoacidosis (DKA) is common in pediatric patients with type 1 diabetes, increasing the risk of recurrent DKA and complicating the transition to subcutaneous insulin. Multiple studies suggest that early administration of long‐acting insulin analogs during DKA management safely improves this transition. Objective This study aimed to determine whether early insulin glargine administration in children with DKA prevents rebound hyperglycemia and recurrent ketosis without increasing the rate of hypoglycemia or hypokalemia. Methods Patients aged 4 h of overlap with intravenous [IV] insulin) and Late (180 mg/dL) was lower in the Early group (66% vs. 85%, p ≤ 0.0001). Hypoglycemia (

Ling Li,1 Xiaodan Zhang,1 Tong Zhang,2 Liankun Zeng,3 Mingrun Lin,4 Yanli Li,4 Wangen Li1 1Department of Endocrinology, The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, People’s Republic of China; 2Department of Endocrinology, The Third Affiliated Hospital, Southern Medical University, Guangzhou, People’s Republic of China; 3Department of Endocrinology, The Fourth Affiliated Hospital, Guangzhou Medical University, Guangzhou, People’s Republic of China; 4Department of Endocrinology, The Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, People’s Republic of ChinaCorrespondence: Wangen Li; Yanli Li, Email liwg660@126.com; liyanli0735@163.comAim: Insulin titration often faces inertia, hindering glycemic control. A patient-centered approach empowers patients to overcome this inertia. This study aims to compare the effectiveness of patient-preferred and guideline-recommended self-titration algorithms in achieving glycemic targets and improving adherence.Methods: Outpatients with type 2 diabetes (T2D) who did not respond to oral antihyperglycemic drugs (OAD) were assessed. They were randomly assigned to patient-preferred and guideline-recommended groups. In the patient-preferred group, individuals selected an algorithm to self-adjust their insulin glargine dosage by 2 units every 3 days if the mean fasting blood glucose (FBG) over the past 3 consecutive days was ≥ 7.0 mmol/L, or by 1 unit daily if the FBG on the same day was ≥ 7.0 mmol/L. In the guideline-recommended group, insulin glargine was titrated by 2 units every 3 days if the mean FBG over the past 3 consecutive days was ≥ 7.0 mmol/L. The FBG target was set below < 7.0 mmol/L.Results: Thirty-nine participants in the patient-preferred group and 42 in the guideline-recommended group completed the study. The cumulative rates of achieving the FBG target in the patient-preferred group compared to the guideline-recommended group were 69.2% vs 54.8% (χ²=1.792, p=0.181) in week 1, 89.7% vs 73.8% (χ²=3.403, p = 0.065) in week 2, 94.9% vs 76.2% (χ²=17.638, p=0.000) in week 3, and 100.0% vs 88.1% (χ²=4.405, p=0.036) in week 4. Adherence rates were significantly higher in the patient-preferred group (97.4%, 37/38) compared to the guideline-recommended group (66.7%, 28/42) (χ²=12.688, p=0.000). Insulin glargine dosage at FBG target achievement was 21.2± 4.3 U in the patient-preferred group and 18.8± 6.7 U in the guideline-recommended group (t=1.888, p=0.063). Hypoglycemia was reported in 1 patient in the guideline-recommended group, with no instances in the patient-preferred group.Conclusion: The patient-preferred self-titration algorithm demonstrates a higher rate of reaching glucose targets and improved adherence.Trial Registration Number: ChiCTR2100050805.Keywords: type 2 diabetes, glargine, self-titration, adherence, preference

Patients with diabetes mellitus increase significantly every year. The increasing number of people with diabetes mellitus results in increased insulin requirements. There are two types of insulin used for diabetes mellitus treatment: human insulin and insulin analogues. Escherichia coli, Pichia pastoris, Saccharomyces cerevisiae, or Hansenula polymorpaha has been used to produce human insulin and insulin analogues. Pichia pastoris can produce glargine in large quantities, and the insulin protein produced will be secreted outside the cell to facilitate the purification process. The advantage of glargine has a long working time of up to 24 hours. Hence, glargine is more effective because patients with diabetes receive glargine injections only once daily. The research started with cloning the glargine gene, transforming pPICZαA-G plasmid into Pichia pastoris, and testing glargine production. 20 recombinant Pichia pastoris colonies were selected and regenerated. Eight recombinant Pichia pastoris colonies were tested for glargine production, and six colonies were detected producing glargine by electrophoresis SDS-PAGE gel stained with Coomassie blue. This study aims to produce glargine using Pichia pastoris as an expression system capable of producing glargine extracellularly, thus simplifying the purification process. [ABSTRACT FROM AUTHOR]

Background: Ultra-long-acting insulin analogs [insulin degludec (IDeg) and insulin glargine 300 units/mL (IGla-300)] offer a longer duration of action with less risk of hypoglycemia compared to other long-acting insulins. However, data about the comparative efficacy and safety are inconsistent. Methods: We searched CENTRAL, PubMed, Embase, ICTRP Search Portal, and ClinicalTrials.gov on 7 October 2022. Randomized controlled trials (RCTs) comparing the safety and efficacy of IDeg (100 or 200 units/mL) and IGla-300 in patients with type 1 or type 2 diabetes were included. Three review authors independently selected trials, assessed the risk of bias, extracted data, and evaluated the overall certainty of the evidence using GRADE. The primary outcomes were the change in glycated hemoglobin (HbA1c) and any hypoglycemia; the secondary outcomes were the change in fasting plasma glucose (FPG) and severe and nocturnal hypoglycemia. Results: Four open-label RCTs were included (2727 participants), 3 parallel and 1 cross-over. Overall, the risk of bias assessment yielded some concern or high risk. There was a comparable change in HbA1c from baseline to the end of treatment, a mean difference of 0.07% (95% confidence interval (CI) 0.06 - 0.19; p = 0.29; 3 trials; 2652 patients; very low-certainty evidence), and a comparable rate of any hypoglycemia, rate ratio 1.02 (95% CI 0.8 - 1.3; p = 0.87; 3 trials; 2881 patients; very low-certainty evidence). IDeg resulted in more reduction in FPG compared to IGla-300, mean difference of 10.27 mg/dL (95% CI 7.25 - 13.29; p < 0.001; 3 trials; 2668 patients; low-certainty evidence). Similar rates of nocturnal and severe hypoglycemia were observed, rate ratio of 1.13 (95% CI 0.72 - 1.78; p = 0.54; 3 trials; 2668 patients; very low-certainty evidence) and 1.4 (95% CI 0.41 - 4.73; p = 0.59; 2 trials; 1952 patients; very low-certainty evidence), respectively. Conclusion: There is no evidence of a difference between IDeg and IGla-300 in the mean change in HbA1c and the risk of anytime, nocturnal, and severe hypoglycemia. IDeg appeared to cause a higher reduction in FPG compared to IGla-300. However, this finding should be interpreted with caution due to the small number of trials included and their high risk of bias. [ABSTRACT FROM AUTHOR]

Insulin edema is a poorly understood complication of insulin therapy. It has been reported in patients with both type 1 and 2 diabetes mellitus and typically occurs in patients with newly diagnosed or poorly controlled diabetes mellitus either after initiation or intensification of insulin therapy. A 20-year-old man presented with anorexia, polydipsia, and weight loss. Serum glucose on admission was 824 mg/dL (45.8 mmol/L) and hemoglobin A1c was >14.0. Additional workup was notable for positive anti-IA2 antibodies and low C-peptide of 0.5 ng/mL (1.1-4.4 ng/mL). He was diagnosed with type 1 diabetes mellitus and was started on insulin therapy with glargine and lispro. Within 4 days after insulin initiation, he developed bilateral leg swelling and reported a 25-pound (11.3-kg) weight gain over the next 10 days. After excluding other systemic causes of edema such as heart failure, renal failure, and liver failure, a diagnosis of insulin edema was made. Insulin glargine was switched to insulin degludec. Complete resolution of edema occurred within 3 days of switching the insulins. Insulin edema is a diagnosis of exclusion. Insulin's role in renal sodium handling, vasodilation, and increased vascular permeability have been postulated as possible mechanisms. Clinicians should be aware of this rare complication. [ABSTRACT FROM AUTHOR]

Background: Insulin icodec is a novel, long-acting, once-weekly basal insulin analog. Its comparative efficacy and safety with basal once-daily insulins in type 2 diabetes mellittus is uncertain. Objective: Evaluate potential efficacy, benefits and risks associated with icodec compared to once-daily basal insulin analogs (degludec or glargine). Methods: We systematically searched PubMed, Cochrane, and Embase for randomized controlled trials (RCTs) published until June 2023 comparing icodec versus long-acting insulin analogs (degludec and glargine) in type 2 diabetes mellitus (T2DM) with at least 12 weeks of follow-up. Binary endpoints were assessed with risk ratios (RRs) and continuous endpoints were compared using mean differences (MDs), with 95% confidence intervals (CIs). The protocol was registered in PROSPERO (CRD42023452468). Results: A total of seven RCTs and 3286 patients with T2DM were included, of whom 1509 (60.6%) received icodec treatment. The follow-up period ranged from 16 to 78 weeks. Compared with once-daily basal insulin analogs, icodec led to a greater improvement in HbA1c (MD -0.15%; 95% CI -0.21, −0.10; p

Introduction: The prevalence of type 2 diabetes mellitus (T2DM) has increased in Saudi Arabia over recent decades, with current estimates showing that 19% of adults have T2DM. There is a need to confirm the clinical outcomes and safety of iGlarLixi in the routine clinical practice setting. Methods: A multicenter retrospective non-comparative study was conducted on 224 people with T2DM on Oral anti-diabetics (OADs) or in combination with basal insulin who initiated treatment with iGlarLixi in Saudi Arabia. Data of at least 180 days (± 30 days) before and after initiating iGlarLixi were retrieved. Results: Mean HbA1c significantly decreased after iGlarLixi start, with a mean reduction of 1.6% at six months. The mean reduction in the FPG was −38.8 (95% CI -46.5 to −31.1, p

BackgroundUltra-long-acting insulin analogs [insulin degludec (IDeg) and insulin glargine 300 units/mL (IGla-300)] offer a longer duration of action with less risk of hypoglycemia compared to other long-acting insulins. However, data about the comparative efficacy and safety are inconsistent.MethodsWe searched CENTRAL, PubMed, Embase, ICTRP Search Portal, and ClinicalTrials.gov on 7 October 2022. Randomized controlled trials (RCTs) comparing the safety and efficacy of IDeg (100 or 200 units/mL) and IGla-300 in patients with type 1 or type 2 diabetes were included. Three review authors independently selected trials, assessed the risk of bias, extracted data, and evaluated the overall certainty of the evidence using GRADE. The primary outcomes were the change in glycated hemoglobin (HbA1c) and any hypoglycemia; the secondary outcomes were the change in fasting plasma glucose (FPG) and severe and nocturnal hypoglycemia.ResultsFour open-label RCTs were included (2727 participants), 3 parallel and 1 cross-over. Overall, the risk of bias assessment yielded some concern or high risk. There was a comparable change in HbA1c from baseline to the end of treatment, a mean difference of 0.07% (95% confidence interval (CI) 0.06 – 0.19; p = 0.29; 3 trials; 2652 patients; very low-certainty evidence), and a comparable rate of any hypoglycemia, rate ratio 1.02 (95% CI 0.8 – 1.3; p = 0.87; 3 trials; 2881 patients; very low-certainty evidence). IDeg resulted in more reduction in FPG compared to IGla-300, mean difference of 10.27 mg/dL (95% CI 7.25 – 13.29; p < 0.001; 3 trials; 2668 patients; low-certainty evidence). Similar rates of nocturnal and severe hypoglycemia were observed, rate ratio of 1.13 (95% CI 0.72 – 1.78; p = 0.54; 3 trials; 2668 patients; very low-certainty evidence) and 1.4 (95% CI 0.41 – 4.73; p = 0.59; 2 trials; 1952 patients; very low-certainty evidence), respectively.ConclusionThere is no evidence of a difference between IDeg and IGla-300 in the mean change in HbA1c and the risk of anytime, nocturnal, and severe hypoglycemia. IDeg appeared to cause a higher reduction in FPG compared to IGla-300. However, this finding should be interpreted with caution due to the small number of trials included and their high risk of bias.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022364891, identifier CRD42022364891.

Introduction: Real-world evidence on insulin glargine 100 U/ml (Gla-100) initiation in Indian type 2 diabetes mellitus (T2DM) individuals is limited. The present study aimed to evaluate the effectiveness of Gla-100 in insulin-naïve T2DM participants from India. Methods: This post hoc analysis includes real-world data of insulin-naïve Indian participants with T2DM who started Gla-100 treatment in two Asian registries: FINE ASIA and GOAL. Changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), body weight, insulin dose, and incidence of hypoglycemia from baseline to 6 months were assessed. Results: A total of 955 participants with T2DM were identified and analyzed. The mean [standard deviation (SD)] age and duration of diabetes were 54.7 (9.8) years and 9.8 (6.3) years, respectively. Mean HbA1c and FPG were significantly reduced after 6 months of Gla-100 treatment [− 2.07 (1.4) %; − 94.4 (65.2) mg/dl, respectively]. HbA1c targets of < 7.0% and < 7.5% were achieved by 292 (30.6%) and 589 (61.7%) study participants, respectively. The overall incidence of hypoglycemia was low (n = 52; 5.4%); only two participants (0.2%) reported severe hypoglycemia. Insulin was titrated with a mean (SD) increment of 2.5 (5.6) U/day after 6 months, leading to a mean Gla-100 dose of 18.2 (8.9) U/day. Mean body weight remained unchanged from baseline to 6 months (− 0.1 kg). Conclusion: In routine clinical practice, Gla-100 significantly improved glycemic parameters after 6 months of treatment with a low risk of hypoglycemia and no weight change in participants with T2DM. [ABSTRACT FROM AUTHOR]

Context. There are evidences that excessive production of reactive oxygen species is one of important abnormalities that contribute to development of chronic diabetic complications. Objective. To test the effect of intensive insulin therapy with analogues through the examining the level of oxidative stress parameters. Subjects and Methods. Comparison of data obtained by prospective analysis in 49 patients with T1DM was used, before and after six months of intensive insulin analog therapy. Results. The values of all three investigated parameters of oxidative stress malondialdehyde (MDA); xanthine oxidase (XO) and nitrates and nitrites (NOx) in our population with T1DM compared to the control (group of 42 voluntary blood donors) are statistically higher. The levels of antioxidant protection parameters compared to the control group also differ; the activities of catalase and glutathione peroxidase (GPx) are statistically higher in our population of T1DM patients compared to the control and superoxide dismutase (SOD) activities are statistically lower. The values of all three examined parameters of oxidative stress decrease after six months of intensive insulin analog therapy and were statistically lower after the therapy: for MDA p<0.001, for XO p<0.01 and for NOx p<0.05. The activities of catalase (p<0.001) and GPx (p<0.01) both decrease with therapy, while the activity of SOD is highest after the sixth month of therapy (p<0.001). Conclusion. In our patients with T1DM compared to the control the level of oxidative stress is significantly higher. Intensive insulin analog therapy with aspart and glargine promotes predominantly the improvement of oxidative stress, and in a less degree antioxidant protection. [ABSTRACT FROM AUTHOR]

Background: In youth with type 1 diabetes (T1D), high haemoglobin A1c (HbA1c) levels are associated with an increased risk for diabetic ketoacidosis (DKA). Aims: This study examined whether daily school‐supervised basal insulin injections were feasible and if they reduced the risk of morning ketosis in children and adolescents with high HbA1c levels. We hypothesized that supervised glargine and degludec would reduce the risk of ketosis and that the prolonged action of degludec would protect from ketosis after consecutive days of unsupervised injections. Materials & Methods: After a 2–4‐week run‐in, youth (10–18 years, HbA1c ≥ 8.5%) managing T1D with injections were randomized to school‐supervised administration of degludec or glargine for 4 months. School nurses observed daily blood β‐hydroxybutyrate (BHB) and glucose checks. During COVID closures, the research team supervised procedures remotely. Results: Data from 28 youth (age 14.3 ± 2.3 years, HbA1c 11.4 ± 1.9%, 64% F) were analysed. School‐supervised injections of both basal insulins for 1–4 days progressively lowered the percent of participants with elevated BHB. The percent of participants with elevated BHB (≥0.6 mmol/L) after 2 days of unsupervised basal insulin doses at home was greater in the glargine than degludec group but had a high p‐value (17.2% vs. 9.0%, p = 0.3). HbA1c was unchanged in both groups. Discussion: In youth with T1D at high risk for DKA, daily supervised long‐acting insulin administration decreased the probability of elevated ketone levels on subsequent school days, regardless of basal insulin type. A larger sample size may have demonstrated that the longer action profile of degludec would offer additional protection from ketosis during days of not attending school. Conclusion: Engaging school‐based caregivers in management of youth with T1D on injected insulin may decrease clinically significant ketosis and minimize acute complications of diabetes. [ABSTRACT FROM AUTHOR]

Copyright of Nouveau Praticien Vétérinaire Canine & Féline is the property of EDP Sciences and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Basal insulin is the first and main component of insulin therapy in patients with type 2 diabetes mellitus (T2DM). Based on the shortcomings of human NPH insulin and the advantages provi­ded by long-acting basal insulin analogues, they are recommended for priority use in patients with T2DM. The leading factor in the success of insulin therapy is titration of its dose with the achievement of the target range of glycemia. Data from clinical trials and real clinical practice indicate that simpler dose titration algorithms ensure better achievement of glycemic goals with a lower risk of hypoglycemia. In addition, simple dose titration algorithms are better accepted by patients and increase satisfaction with treatment. The leading societies of diabetologists ADA/EASD and AACE/ACE re­commend the use of simple dose titration algorithms. Recent clinical trials on the effectiveness of the insulin glargine dose titration based on the INSIGHT algorithm, which, unlike the traditional options for changing the dose 1–2 times a week, involves a daily correction of the insulin glargine dose by 1 Unit, have proven its effectiveness and safety. Most patients prefer this type of insulin dose titration. The same titration algorithm can be used for a fixed combination of glargine with li­xisenatide, which was also confirmed by the results of clinical trials. In general, simplified options for correcting the basal insulin dose have demonstrated their effectiveness and allow increa­sing the percentage of patients who manage to achieve the glycemic goal without increasing the risk of hypoglycemia. When prescribing basal insulin, physician must determine the target range of glycemia, demonstrate the titration algorithm that is acceptable for each insulin and which a patient will use to achieve the glycemic goal.

Initiation of insulin therapy with basal insulin analogues has become the standard of care for type 2 diabetes mellitus (T2DM). Timely administration of insulin allows not only to slow down the progression of type 2 diabetes, but also to reduce the frequency and severity of complications associated with it. This paper reviews the efficacy and safety of the use of the latest basal insulin analogues in type 2 diabetes from the perspective of current clinical guidelines, and also reviews updated data on the efficacy and safety of therapy by various members of the class. In this paper a review of the efficacy and safety of latest basal insulin analogues use in T2DM from the standpoint of current clinical guidelines has been carried out, and updated data on the efficacy and safety of therapy by various members of the class have been reviewed, taking into account their impact on the risk of hypoglycemia and glycemic variability. The available data indicate that insulin degludec 200 U/mL may be the drug of choice for those at high risk of developing severe forms of hypoglycemia. Since severe hypoglycemia and high glycemic variability are important risk factors for cardiovascular events and mortality, it has been shown that a differentiated approach to insulin therapy in the treatment of T2DM is currently advisable, taking into account the effect on the risk of hypoglycemia and glycemic variability.

Abstract Background To assess the impact of long-acting insulin analogues, compared to intermediate acting neutral protamine Hagedron (NPH), on maternal, perinatal and neonatal outcomes. Methods Studies for inclusion in the review were identified using a structured search strategy in PubMed, Scopus and Cochrane Central Register of Controlled Trials (CENTRAL) database. Studies that were randomized controlled trials or observational in design were considered for inclusion. Eligible studies should have compared the maternal, perinatal and neonatal outcomes between pregnant women with gestational diabetes mellitus (GDM) managed by intermediate acting (NPH) and by long-acting insulin analogues. Statistical analysis was performed using STATA software. Results We found 17 studies to be eligible for inclusion. The mean gestational weight gain and risk of maternal hypoglycaemia, hypertensive disorder, caesarean delivery, spontaneous abortion, endometritis and wound infection or dehiscence were similar among pregnant women with GDM managed using long-acting insulin analogues and NPH. Those receiving long-acting insulin analogues had significantly lower HbA1c values in the second (WMD − .09, 95% CI 0.12, − 0.06; N = 4) and third trimester (WMD − 0.08, 95% CI − 0.14, − 0.02; N = 12). The mean gestational age and birth weight and risk of perinatal mortality, prematurity, large for gestational age, small for gestational age, shoulder dystocia and congenital abnormalities was similar among babies in both groups. No statistically significant differences in risk of admission to neonatal intensive care unit, respiratory distress, neonatal hypoglycaemia, 5 min APGAR score of

Basal insulin is the first and main component of insulin therapy in patients with type 2 diabetes mellitus (T2DM). Based on the shortcomings of human NPH insulin and the advantages provided by long-acting basal insulin analogues, they are recommended for priority use in patients with T2DM. The leading factor in the success of insulin therapy is titration of its dose with the achievement of the target range of glycemia. Data from clinical trials and real clinical practice indicate that simpler dose titration algorithms ensure better achievement of glycemic goals with a lower risk of hypoglycemia. In addition, simple dose titration algorithms are better accepted by patients and increase satisfaction with treatment. The leading societies of diabetologists ADA/EASD and AACE/ACE recommend the use of simple dose titration algorithms. Recent clinical trials on the effectiveness of the insulin glargine dose titration based on the INSIGHT algorithm, which, unlike the traditional options for changing the dose 1–2 times a week, involves a daily correction of the insulin glargine dose by 1 Unit, have proven its effectiveness and safety. Most patients prefer this type of insulin dose titration. The same titration algorithm can be used for a fixed combination of glargine with lixisenatide, which was also confirmed by the results of clinical trials. In general, simplified options for correcting the basal insulin dose have demonstrated their effectiveness and allow increasing the percentage of patients who manage to achieve the glycemic goal without increasing the risk of hypoglycemia. When prescribing basal insulin, physician must determine the target range of glycemia, demonstrate the titration algorithm that is acceptable for each insulin and which a patient will use to achieve the glycemic goal. [ABSTRACT FROM AUTHOR]

Background: The effectiveness and safety of a fixed combination of insulin glargine 100 ME/ml and lixisenatide for treatment of patients with type 2 diabetes (T2DM) has been demonstrated in randomized clinical trials, but there are still not enough data of it`s usage of it real clinical practice.Aim: To describe the baseline characteristics of patients with T2DM who started treatment with a fixed ratio combination of insulin glargine 100 ME/ml and lixisenatide in the period from November 2018 to July 2020, and to evaluate the effectiveness of using fixed combination of insulin glargine 100 ME/ml and lixisenatide in for 6–12 months of therapy in a real outpatient practice.Materials and methods: SOLO was a retrospective cohort multicentre study conducted in Russia, Moscow. Adults (≥18 years) with T2DM and HbA1c≥7% in case of availability of medical records during ≥180 days before and ≥1 HbA1c level during 150–210 days after start of treatment with Soliqua SoloStar® were eligible.Results: A total of 383 people with T2DM were included. Baseline characteristics were the following (mean±SD): age 59.9±8.3 years; BMI 36.4±6.3 kg/m2; proportion of patients with BMI≥35 kg/m2 — 52.2%; HbA1c 9.14±1.08%. 65% of patients received oral antidiabetic drugs (OAD) before start of treatment with fixed combination of insulin glargine 100 ME/ml and lixisenatide ; 31.3% of patients were switched from combination of OAD with basal insulin, 1.04% of patients received other therapy (GLP-1 RA, basal-bolus insulin treatment, basal insulin monotherapy), and 2.61% of patients did not receive any hypoglycemic therapy. HbA1c level was 7.78±0.8% after 6 months of treatment and 7.4±0.61% after 12 months. There was a significant decrease of body weight from the baseline value 101.62±20.64 kg by 1.96±4.03 kg at month 6 and by 3.13±4.71 kg at month 12 (p

Rationale: Tuberculosis (TB) and diabetes mellitus (DM) are converging epidemics, each worsening the morbidity of the other. Chronic hyperglycemia is associated with dysfunctional immunity to Mycobacterium in patients with DM and, therefore, is likely to decrease the efficiency of anti-mycobacterial treatment. Early aggressive management of TB and timely initiation of insulin therapy helps in controlling the glycemic excursions that are otherwise not controlled by multiple oral antidiabetic agents. Patient Concerns: A 42-year-old female with type 2 diabetes for six years presented with complaints of persistent cough, pain in the chest, weight loss, and loss of appetite for two months in November 2018. Diagnosis: The patient was diagnosed with multidrug-resistant TB (MDR-TB), which further progressed to extensively drug-resistant TB (XDR-TB) in February 2019. Her hemoglobin A1c (HbA1c), which was 8.3% prior to TB diagnosis, increased to 13.8%. Interventions: The patient was initiated on anti-TB medications as per the Revised National TB Control Programme (RNTCP) guidelines. The antidiabetic regimen consisted of glimepiride 2 mg b.i.d, metformin 500 mg b.i.d, and voglibose 0.2 mg b.i.d. On confirmation of XDR-TB and persistently high HbA1c, insulin glargine was initiated in July 2019. Due to continued uncontrolled blood glucose levels, insulin IDegAsp (30% Aspart and 70% Degludec) was initiated in February 2020. Results: After the initiation of IdegAsp, HbA1c levels reduced significantly and there was improvement in the measures of daily blood glucose level indices such as time in target range (TIR), time below target range (TBR), and time above target range (TAR). Optimal blood glucose was achieved in a significant amount of time in a day. Sputum was negative for XDR-TB in February 2021, and the patient recovered from TB. Her HbA1c was reported to be 7.5% in February 2021. Conclusion: In patients with type 2 diabetes and TB, maintaining optimal blood glucose level for a longer duration of time can have a positive impact on host immunity and also enhance the effect of ATT and better outcomes of TB infection. This case study highlights the importance of good glycemic control in patients with type 2 diabetes who acquire TB infection.

Background: To assess the impact of long-acting insulin analogues, compared to intermediate acting neutral protamine Hagedron (NPH), on maternal, perinatal and neonatal outcomes. Methods: Studies for inclusion in the review were identified using a structured search strategy in PubMed, Scopus and Cochrane Central Register of Controlled Trials (CENTRAL) database. Studies that were randomized controlled trials or observational in design were considered for inclusion. Eligible studies should have compared the maternal, perinatal and neonatal outcomes between pregnant women with gestational diabetes mellitus (GDM) managed by intermediate acting (NPH) and by long-acting insulin analogues. Statistical analysis was performed using STATA software. Results: We found 17 studies to be eligible for inclusion. The mean gestational weight gain and risk of maternal hypoglycaemia, hypertensive disorder, caesarean delivery, spontaneous abortion, endometritis and wound infection or dehiscence were similar among pregnant women with GDM managed using long-acting insulin analogues and NPH. Those receiving long-acting insulin analogues had significantly lower HbA1c values in the second (WMD −.09, 95% CI 0.12, − 0.06; N = 4) and third trimester (WMD − 0.08, 95% CI − 0.14, − 0.02; N = 12). The mean gestational age and birth weight and risk of perinatal mortality, prematurity, large for gestational age, small for gestational age, shoulder dystocia and congenital abnormalities was similar among babies in both groups. No statistically significant differences in risk of admission to neonatal intensive care unit, respiratory distress, neonatal hypoglycaemia, 5 min APGAR score of < 7, neonatal hyperbilirubinemia and sepsis was observed. The quality of pooled evidence, as per GRADE criteria, was judged to be "very low" for all the maternal and neonatal outcomes considered. Conclusions: Findings suggest no significant differences in the maternal, perinatal and neonatal outcomes between intermediate and long-acting insulin analogues. The results provide support for use of long-acting insulin analogues in women with GDM. However, evidence is still needed from high quality randomized controlled trials to arrive at a recommendation for inclusion in routine clinical care. [ABSTRACT FROM AUTHOR]

Background: Diabetic retinopathy (DR) is the major cause of preventable blindness worldwide. DR is a microvascular complication of diabetes mellitus that is more prevalent in patients with type 1 diabetes. Type 1 diabetes mellitus is an autoimmune disease that leads to insulin deficiency so patients require long term therapy with basal insulin for optimum glycemic control. Insulin-like growth factor 1 (IGF-1) is an important growth factor that is involved in cell proliferation and angiogenesis. There is a lot of evidence that IGF-1 is tightly related to DR development. Insulin Glargine is a long-acting insulin analogue which is peak-free and less hypoglycemic as compared to the intermediate-acting NPH insulin. Glargine has an increased affinity to IGF-1 receptor and this raised concern about its role in development of DR. The relationship between diabetic retinopathy, basal insulin therapy and IGF-1 serum level is still in debate. Aim: we aimed to compare the incidence and severity of diabetic retinopathy in type 1 diabetic patients on basal insulin therapy (Glargine or NPH) and its relation to serum IGF-1 level. Methods: The current study included 88 subjects with type 1 diabetes divided into 44 on basal insulin therapy with Glargine and actrapid (Group A) and 44 on NPH and actrapid (Group B). Hemoglobin A1c, Total cholesterol, Triglycerides, High density lipoproteins, Low density lipoproteins and serum IGF-1 levels were assessed. Full clinical examination including (weight, height, BMI), vital signs (pulse, blood pressure) was done and Fundus examination by Optomed Aurora'® IQ handheld fundus camera. Results On comparing the 2 studied groups, There was no statistical significant difference as regarding fundus examination findings between studied groups (P value = 0.429). There was no statistically significant relation between diabetic retinopathy and serum IGF-1 (P value = .080 with Mean ± SD of serum IGF-1 level in patients with Normal fundus 14.8 ± 11 vs. Patients with Diabetic retinopathy 21.3 ± 16.9). There was statistically significant association between diabetic retinopathy and duration of diabetes (P value< 0.05 with Mean ± SD of diabetes duration in patients with Diabetic retinopathy 17.7 ± 6.9 vs. Patients with Normal fundus 14.6 ± 5.6). There was a statistical significant difference as regarding age (P value< 0.05 with Mean ± SD of age in Group B regimen 28.4 ± 6.7 vs. Group A 25.5 ± 4.9). Conclusion: Serum IGF-1 levels showed no statistically significant difference in patients either on Glargine or NPH and also in patients either with normal fundus or with diabetic retinopathy. The incidence and severity of diabetic retinopathy in patients with type 1 diabetes mellitus is directly proportionate to duration of disease. No noted difference concerning diabetic retinopathy changes between patients on basal insulin therapy either Glargine or NPH. [ABSTRACT FROM AUTHOR]

Abstract Background Cystic Fibrosis Related Diabetes (CFRD) is a frequent comorbidity of patients with Cystic Fibrosis (CF). A worsening of clinical conditions appears before CFRD. It has been demonstrated a decline in pulmonary function and nutritional status also in patients with prediabetes. Few trials show that insulin may be beneficial in prediabetic CF patients, to date guidelines do not recommend for this condition. Case presentation We report a case of a patient treated with insulin glargine at 13 years, due to glycemic intolerance, and with Lumacaftor/Ivacaftor at 15 years. A reduction of pulmonary exacerbations was observed after glargine therapy, also confirmed after the starting of Lumacaftor/ Ivacaftor in this patient. Pulmonary function improved only after the first year of glargine therapy, then a deterioration appeared due to the natural history of CF lung damage. During the COVID-19 lockdown, poor adherence to care contributed to diabetes mellitus onset needing high insulin requirements. After two weeks the patient returned to prediabetic condition and his previous dose of glargine. Conclusions our case highlights firstly that insulin glargine has contributed to preserve him from further clinical worsening due to prediabetes in the years before pandemic, secondly the negative impact of COVID-19 lockdown on the clinical course of a chronic disease as CF.

Stephan Kress,1 Anja Borck,2 Ariel Zisman,3 Peter Bramlage,4,5 Thorsten Siegmund6 1Diabeteszentrum, Vinzentius-Krankenhaus, Landau, Germany; 2Medical Department, Sanofi, Berlin, Germany; 3The Endocrine Center of Aventura, Aventura, FL, USA; 4Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany; 5Department for Angiology, Brandenburg Medical School, Campus Brandenburg/Havel, Brandenburg, Germany; 6Diabetes- Hormon- Und Stoffwechselzentrum Am Isar Klinikum München, München, GermanyCorrespondence: Stephan KressDiabeteszentrum, Vinzentius Krankenhaus, Cornichonstr. 4, Landau, 76829, GermanyTel +49 6341 172208Email kress.innere@vinzentius.deAim: In the present analysis, we characterised the efficacy and safety of adding a single daily injection of insulin glulisine to optimised basal-supported oral therapy (BOT) in patients with a high BeAM value, defined as a more than 50 mg/dl difference between bedtime and pre-breakfast blood glucose.Methods: The BeAM value was retrospectively calculated for patients pooled from two clinical trials that supplemented BOT with glulisine. Data regarding changes in HbA1c, fasting plasma glucose (FPG), and postprandial glucose (PPG) levels from observation periods of 3 to 6 months were assessed.Results: Out of 358 patients that received BOT/glulisine, 182 had a high BeAM value. Patients with a high BeAM value were older and had a longer diabetes duration than patients with a medium BeAM value. Significant reductions in HbA1c (7.5% to 7.2% [59 to 55 mmol/mol], p< 0.0001) and PPG (202 to 143 mg/dl, p< 0.0001) levels were documented. The proportion of patients with a high BeAM value achieving an HbA1c < 7% [53 mmol/mol], alone or in combination with no hypoglycaemia, was lower than that of patients with a medium BeAM value.Conclusion: The analysis indicates that the supplementation of BOT with a single daily injection of prandial insulin is safe and effective for reducing HbA1c and PPG levels in patients with a high BeAM value (more than 50 mg/dl). However, patients with a medium BeAM value also responded well, which suggests that they should also be considered candidates for this change in therapy.Keywords: basal-plus, prandial insulin, type-2 diabetes, glulisine, glargine

The evolution of basal insulin therapy over the past 100 years since the discovery of insulin is a testimony to the biomedical bench‐to‐bedside process, wherein incremental advances in the basic sciences are progressively translated over time into a series of enhancements in clinical care, each building upon the success of its predecessors. The emergence of recombinant DNA technology and the resultant biosynthesis of human insulin in the 1980s provided the critical capacity to bioengineer designer insulin analogues with pharmacokinetic and pharmacodynamic properties that can better mimic, although not fully replicate, the effects of endogenous insulin secretion. Through these efforts, basal insulin therapy has progressed over this time from first‐generation analogues (glargine U‐100, detemir) to second‐generation analogues (glargine U‐300, degludec) to ultra‐long‐acting formulations that are suitable for administration once weekly (icodec). Each iteration in this progression has represented a step closer towards the goal of replicating the continuous secretion of insulin that normally comprises the basal output of the pancreatic beta‐cells between meals, during episodes of fasting and overnight. However, it may be that we may have reached the achievable limit in the context of an "open‐loop" approach, such that only with the addition of closed loop control will we be able to achieve physiologic basal insulin replacement. In this review, we will examine the evolution of basal insulin therapy over the past 100 years and its implications for patient care and outcomes in current practice and the future. [ABSTRACT FROM AUTHOR]

Aims: Limited data exist about the use of insulin degludec in the hospital. This multicentre, non‐inferiority, open‐label, prospective randomized trial compared the safety and efficacy of insulin degludec‐U100 and glargine‐U100 for the management of hospitalized patients with type 2 diabetes. Methods: In total, 180 general medical and surgical patients with an admission blood glucose (BG) between 7.8 and 22.2 mmol/L, treated with oral agents or insulin before hospitalization were randomly allocated (1:1) to a basal‐bolus regimen using degludec (n = 92) or glargine (n = 88), as basal and aspart before meals. Insulin dose was adjusted daily to a target BG between 3.9 and 10.0 mmol/L. The primary endpoint was the difference in mean hospital daily BG between groups. Results: Overall, the randomization BG was 12.2 ± 2.9 mmol/L and glycated haemoglobin 84 mmol/mol (9.8% ± 2.0%). There were no differences in mean daily BG (10.0 ± 2.1 vs. 10.0 ± 2.5 mmol/L, p =.9), proportion of BG in target range (54·5% ± 29% vs. 55·3% ± 28%, p =.85), basal insulin (29.6 ± 13 vs. 30.4 ± 18 units/day, p =.85), length of stay [median (IQR): 6.7 (4.7‐10.5) vs. 7.5 (4.7‐11.6) days, p =.61], hospital complications (23% vs. 23%, p =.95) between treatment groups. There were no differences in the proportion of patients with BG <3.9 mmol/L (17% vs. 19%, p =.75) or <3.0 mmol/L (3.7% vs. 1.3%, p =.62) between degludec and glargine. Conclusion: Hospital treatment with degludec‐U100 or glargine‐U100 is equally safe and effective for the management of hyperglycaemia in general medical and surgical patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]

To explore the efficacies of liraglutide and glargine in type 2 diabetes patients with malignant tumors treated with glucocorticoids. Overall, 120 patients were recruited, 60 patients were divided into the glargine group (chemotherapy with glucocorticoids and hypoglycemic therapy including glargine) and 60 patients were divided into the liraglutide group (chemotherapy with glucocorticoids and hypoglycemic therapy including liraglutide). Fasting plasma glucose, 2 h postprandial plasma glucose, glycosylated hemoglobin, body mass index, systolic blood pressure, diastolic blood pressure, C peptide, insulin resistance index, insulin secretion index, total cholesterol, triglyceride, high-density lipoprotein, low-density lipoprotein, Karnofsky performance status score, rehospitalization rate, average hospitalization days and adverse reactions before and after intervention were compared between the two groups. After treatment, total cholesterol, highdensity lipoprotein, C peptide, systolic blood pressure, diastolic blood pressure and homeostatic model assessment of insulin resistance were not significantly different between the groups. The body mass index, fasting plasma glucose, 2 h postprandial plasma glucose, glycosylated hemoglobin test (A1c) and homeostasis model assessment of beta cell function were significantly lower in the glargine group than the liraglutide group (p<0.05). The hypoglycemia rate was lower in the liraglutide group than the glargine group (p<0.05). The Karnofsky performance status score was increased (p<0.05) and the rehospitalization rate and average hospitalization days (p<0.05) were decreased in the liraglutide group. Pearson and linear regression analyses indicated that liraglutide treatment was associated with better glucose control, a better homeostasis model assessment of beta cell function, hypoglycemia rate and Karnofsky performance status score and reduced rehospitalization rate and average hospitalization days. Liraglutide treatment significantly improved glucose control, homeostasis model assessment of beta cell function and the hypoglycemia rate and Karnofsky performance status score and reduced the rehospitalization rate and average hospitalization days of type 2 diabetes patients with malignant tumors treated with glucocorticoids. [ABSTRACT FROM AUTHOR]

Rationale: Tuberculosis (TB) and diabetes mellitus (DM) are converging epidemics, each worsening the morbidity of the other. Chronic hyperglycemia is associated with dysfunctional immunity to Mycobacterium in patients with DM and, therefore, is likely to decrease the efficiency of anti-mycobacterial treatment. Early aggressive management of TB and timely initiation of insulin therapy helps in controlling the glycemic excursions that are otherwise not controlled by multiple oral antidiabetic agents. Patient Concerns: A 42-yearold female with type 2 diabetes for six years presented with complaints of persistent cough, pain in the chest, weight loss, and loss of appetite for two months in November 2018. Diagnosis: The patient was diagnosed with multidrug-resistant TB (MDR-TB), which further progressed to extensively drug-resistant TB (XDR-TB) in February 2019. Her hemoglobin A1c (HbA1c), which was 8.3% prior to TB diagnosis, increased to 13.8%. Interventions: The patient was initiated on anti-TB medications as per the Revised National TB Control Programme (RNTCP) guidelines. The antidiabetic regimen consisted of glimepiride 2 mg b.i.d, metformin 500 mg b.i.d, and voglibose 0.2 mg b.i.d. On confirmation of XDR-TB and persistently high HbA1c, insulin glargine was initiated in July 2019. Due to continued uncontrolled blood glucose levels, insulin IDegAsp (30% Aspart and 70% Degludec) was initiated in February 2020. Results: After the initiation of IdegAsp, HbA1c levels reduced significantly and there was improvement in the measures of daily blood glucose level indices such as time in target range (TIR), time below target range (TBR), and time above target range (TAR). Optimal blood glucose was achieved in a significant amount of time in a day. Sputum was negative for XDR-TB in February 2021, and the patient recovered from TB. Her HbA1c was reported to be 7.5% in February 2021. Conclusion: In patients with type 2 diabetes and TB, maintaining optimal blood glucose level for a longer duration of time can have a positive impact on host immunity and also enhance the effect of ATT and better outcomes of TB infection. This case study highlights the importance of good glycemic control in patients with type 2 diabetes who acquire TB infection. [ABSTRACT FROM AUTHOR]

Background: Insulin antibodies (IAs) affect blood glucose control in patients receiving insulin therapy., Aim: To investigate the relationship between different hypoglycemic treatments and IAs in patients with type 2 diabetes mellitus (T2DM)., Methods: This cross-sectional, retrospective study included 1863 patients with T2DM who were receiving exogenous insulin therapy. All patients received stable antidiabetic therapy in the last 3 months and IA levels were measured using an iodine-125 array., Results: A total of 1863 patients were enrolled. There were 902 (48.4%) patients who had positive IAs (IA level > 5%), with a mean IA level of 11.06% (10.39%-11.72%). IA levels were positively correlated with high fasting blood glucose (odds ratio = 1.069, P < 0.001). The proportion of positive IAs was lowest in patients using glargine only (31.9%) and highest in patients using human insulin only (70.3%), P < 0.001. The IA levels in patients using sulfonylureas/glinides (8.3%), metformin (9.6%), and dipeptidyl peptidase-4 inhibitors (8.2%) were all lower than in patients without these drugs (all P < 0.05)., Conclusion: Nearly half of patients on insulin therapy have positive IA antibodies, and IA antibody levels are associated with blood glucose control. Insulin glargine and a combination of oral glucose-lowering drugs were correlated with lower IA levels., Competing Interests: Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)

PICO question In cats with diabetes mellitus, do protamine zinc insulin (PZI) and glargine show a similar effect in reducing clinical signs and hypoglycaemia episodes? Clinical bottom line Category of research question Treatment The number and type of study designs reviewed The number and type of study designs that were critically appraised was one. This study was a non-randomised retrospective trial. A systematic review was also found, which analyses the influence of insulin in diabetic remission Strength of evidence Weak Outcomes reported Compared to PZI, using glargine in recently diagnosed diabetic cats fed exclusively an ultra-low carbohydrate-high protein canned diet, may result in lower fructosamine and mean 12 hour blood glucose concentrations as well as less episodes of hypoglycaemia Conclusion In view of the strength of evidence and the outcomes from the study the following conclusion is made: in cats with diabetes mellitus where currently licensed insulin fails to result in a good glycaemic control, glargine may be considered How to apply this evidence in practice The application of evidence into practice should take into account multiple factors, not limited to: individual clinical expertise, patient’s circumstances and owners’ values, country, location or clinic where you work, the individual case in front of you, the availability of therapies and resources. Knowledge Summaries are a resource to help reinforce or inform decision making. They do not override the responsibility or judgement of the practitioner to do what is best for the animal in their care.

Background: Cystic Fibrosis Related Diabetes (CFRD) is a frequent comorbidity of patients with Cystic Fibrosis (CF). A worsening of clinical conditions appears before CFRD. It has been demonstrated a decline in pulmonary function and nutritional status also in patients with prediabetes. Few trials show that insulin may be beneficial in prediabetic CF patients, to date guidelines do not recommend for this condition. Case presentation: We report a case of a patient treated with insulin glargine at 13 years, due to glycemic intolerance, and with Lumacaftor/Ivacaftor at 15 years. A reduction of pulmonary exacerbations was observed after glargine therapy, also confirmed after the starting of Lumacaftor/ Ivacaftor in this patient. Pulmonary function improved only after the first year of glargine therapy, then a deterioration appeared due to the natural history of CF lung damage. During the COVID-19 lockdown, poor adherence to care contributed to diabetes mellitus onset needing high insulin requirements. After two weeks the patient returned to prediabetic condition and his previous dose of glargine. Conclusions: our case highlights firstly that insulin glargine has contributed to preserve him from further clinical worsening due to prediabetes in the years before pandemic, secondly the negative impact of COVID-19 lockdown on the clinical course of a chronic disease as CF. [ABSTRACT FROM AUTHOR]

Aim: To compare a glucagon‐like peptide‐1 receptor agonist with basal insulin at hospital discharge in patients with uncontrolled type 2 diabetes in a randomized clinical trial. Methods: A total of 273 patients with glycated haemoglobin (HbA1c) 7%–10% (53–86 mol/mol) were randomized to liraglutide (n = 136) or insulin glargine (n = 137) at hospital discharge. The primary endpoint was difference in HbA1c at 12 and 26 weeks. Secondary endpoints included hypoglycaemia, changes in body weight, and achievement of HbA1c <7% (53 mmol/mol) without hypoglycaemia or weight gain. Results: The between‐group difference in HbA1c at 12 weeks and 26 weeks was −0.28% (95% CI −0.64, 0.09), and at 26 weeks it was −0.55%, (95% CI −1.01, −0.09) in favour of liraglutide. Liraglutide treatment resulted in a lower frequency of hypoglycaemia <3.9 mmol/L (13% vs 23%; P = 0.04), but there was no difference in the rate of clinically significant hypoglycaemia <3.0 mmol/L. Compared to insulin glargine, liraglutide treatment was associated with greater weight loss at 26 weeks (−4.7 ± 7.7 kg vs −0.6 ± 11.5 kg; P < 0.001), and the proportion of patients with HbA1c <7% (53 mmol/mol) without hypoglycaemia was 48% versus 33% (P = 0.05) at 12 weeks and 45% versus 33% (P = 0.14) at 26 weeks in liraglutide versus insulin glargine. The proportion of patients with HbA1c <7% (53 mmol/mol) without hypoglycaemia and no weight gain was higher with liraglutide at 12 (41% vs 24%, P = 0.005) and 26 weeks (39% vs 22%; P = 0.014). The incidence of gastrointestinal adverse events was higher with liraglutide than with insulin glargine (P < 0.001). Conclusion: Compared to insulin glargine, treatment with liraglutide at hospital discharge resulted in better glycaemic control and greater weight loss, but increased gastrointestinal adverse events. [ABSTRACT FROM AUTHOR]

introduction. insulin glargine 100 U/ml (gla-100) is a long-lasting basal insulin analog injected once daily. This real-life study aimed to evaluate the efficacy and safety of gla-100 in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM), who were recently switched from isophane (nPh) insulin. Methods. This multicenter, prospective, 52-week observational study included 321 patients with T1DM and 766 with T2DM. The primary endpoint was the percentage of participants with a hbA1c reduction of ≥ 0.5% at 52 weeks. The secondary endpoints included fasting plasma glucose (FPg) and hbA1c reduction over time, and hypoglycemic events. Results. Of the 1,087 patients included, 69.9% achieved the primary endpoint, while the mean hbA1c decreased by 1.03% and the mean FPg by 31.8 mg/dl at 52 weeks. The average annual rate of severe hypoglycemia was 0.017 events per patient-year and 0.82 events per patient-year for nocturnal hypoglycemia. The proportion of participants experiencing severe diurnal or nocturnal hypoglycemia was significantly lower in the four weeks prior to the study end than the four weeks before the switch from NPH insulin (p < 0.0001 for diurnal hypoglycemia in T1DM and < 0.002 for diurnal hypoglycemia in T2DM; p < 0.0001 for nocturnal hypoglycemia in both T1DM and T2DM). Body weight did not change substantially throughout the study (mean increase of 0.3 kg for T1DM and 0.1 kg for T2DM). Conclusions. Patients with T1DM or T2DM in whom diabetes was not well controlled with nPh insulin treatment achieved better glycemic control at a lower risk of hypoglycemia after switching to gla-100 in routine clinical practice. [ABSTRACT FROM AUTHOR]

Background: Insulin icodec is a novel, long-acting, once-weekly basal insulin analog. Its comparative efficacy and safety with basal once-daily insulins in type 2 diabetes mellittus is uncertain., Objective: Evaluate potential efficacy, benefits and risks associated with icodec compared to once-daily basal insulin analogs (degludec or glargine)., Methods: We systematically searched PubMed, Cochrane, and Embase for randomized controlled trials (RCTs) published until June 2023 comparing icodec versus long-acting insulin analogs (degludec and glargine) in type 2 diabetes mellitus (T2DM) with at least 12 weeks of follow-up. Binary endpoints were assessed with risk ratios (RRs) and continuous endpoints were compared using mean differences (MDs), with 95% confidence intervals (CIs). The protocol was registered in PROSPERO (CRD42023452468)., Results: A total of seven RCTs and 3286 patients with T2DM were included, of whom 1509 (60.6%) received icodec treatment. The follow-up period ranged from 16 to 78 weeks. Compared with once-daily basal insulin analogs, icodec led to a greater improvement in HbA1c (MD -0.15%; 95% CI -0.21, -0.10; p < 0.0001; I 2  = 0%) and time in range (TIR) (MD 2.83%; 95%CI 0.94; 4.71; p = 0.003; I 2  = 22%). Body weight was increased with icodec treatment (MD 0.78 Kg; 95%CI 0.42, 1.15; p < 0.01; I 2  = 86%). There was also a higher rate of injection site reactions (RR 1.89; 95%CI 1.12, 3.18; p = 0.016; I 2  = 0%) and nasopharyngitis (RR 1.94; 95%CI 1.11, 3.38; p = 0.020; I 2  = 0%) in the icodec group, compared with once-daily regimens. There was no significant difference between groups in fasting plasma glucose., Conclusions: In this meta-analysis of RCTs, insulin icodec led to better control of HbA1c and TIR as compared with once-daily insulin regimens, albeit with increased weight gain and a higher rate of injection site reaction in the Icodec group., Competing Interests: All authors report no relationships that could be construed as a conflict of interest. All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation. There were no external funding sources for this study., (© 2024 The Authors.)

Outcomes of insulin analogues in pediatric diabetes camps are poorly investigated; no data is available about insulin degludec (IDeg).Our aim was to assess impact of insulin therapy adopted by the participants to a 4-day diabetes camp held in 2017, hypothesizing a possible excess risk of hypoglycemia in patients treated with IDeg. Overall, 40 children with type 1 diabetes (mean age 13.4±3.0 years; 62.5% males) attended the camp (20.0% on continuous subcutaneous insulin infusion and 80.0% on multiple daily injections - MDI). Among children in MDI regimen, 71.9% were treated with IDeg as basal insulin and 28.1% with glargine U100 (IGlar). All patients used Lispro or Aspart as short-acting insulin. Daily plan of the camp included educational sessions, physical exercise, 3 main meals and 2 snacks. At the arrival, IGlar and short-acting insulin doses were revised according to existing guidelines, while IDeg dose was revised based on an empirical individualized approach. At the arrival, insulin doses were reduced in 22 participants (-19.4±10.5%), while doses were increased in 17 children (+17.8±12.7%), based on individual needs. No statistically significant between-group difference emerged in mean blood glucose and glucose variability. No excess risk of hypoglycemia was found in the IDeg group. The study suggests similar effectiveness and safety of different insulin schemes when associated with appropriate diabetes education and management, and flexible dose adjustments. Despite its longer halflife and the lack of a validated algorithm, IDeg was not associated with an excess risk of hypoglycemia.

Abstract Background No data exist about the changes induced by the transition from first‐generation long‐acting insulins to second‐generation long‐acting analogues in the paediatric population. Objective To assess changes in insulin/carbohydrate ratio (I:CHO) after the first 6 months of degludec therapy in a paediatric population with type 1 diabetes previously treated with glargine U100. Subjects All patients treated with degludec under routine clinical practice conditions were retrospectively analysed. Methods Nonprofit observational retrospective study. Changes during the follow‐up in mean CHO/I ratio were assessed using longitudinal linear models for repeated measures. Rate of hypoglycaemia, ketoacidosis and adverse events was evaluated. Results Overall, 51 children (mean age 13.8 ± 4.6 years; mean diabetes duration 5.8 ± 3.9 years) started therapy with degludec in the period between April 2017 and April 2018. I:CHO ratio before starting degludec therapy significantly differed among the three meals, being the lowest at breakfast and the highest at dinner. After introducing degludec, I:CHO ratio at lunch (−1.29 95% CI −2.02;−0.57) and at dinner (−3.08 95% CI −4.35;−1.8) significantly decreased, while it slightly increased at breakfast (+1.37 95% CI 0.47;2.28). No episodes of severe hypoglycaemia, ketoacidosis and adverse event were recorded during 6 months. Conclusions Our data show that the use of degludec is associated with a significant change in the I:CHO ratio at the different meals compared to the previous glargine therapy. This could derive from the flat and prolonged pharmacokinetic profile of degludec. This has important clinical implications for daily insulin dose adjustments.

Abstract Background This study aimed to examine the switch from glargine+once daily insulin aspart (1 + 1 regimen) to glargine+insulin aspart 30 before breakfast combined with exercise and in patients with type 2 diabetes mellitus (T2DM) with poorly controlled blood glucose levels. Methods Consecutive patients with poorly controlled T2DM (n = 182) were switched from the 1 + 1 regimen to glargine+insulin aspart 30 before breakfast in combination with exercise after dinner and dividing meals in two (same final calories intake). The insulin doses were adjusted according to blood glucose levels within 4 weeks after the switch and maintained for 12 weeks. Fasting blood glucose (FBG), 2-hpostprandial glucose (2hPG), glycosylated hemoglobin (HbA1c), body mass index (BMI), daily insulin dose, and hypoglycemia events were assessed. Results Sixteen weeks after the switch, 2 h PG levels and HbA1c levels (from 8.5 to 7.4%, P = 0.001) were improved. The proportions of patients reaching the HbA1c targets of 7.5% were improved (from 22.5 to 58.7%, P = 0.001). Among the 182 patients, 24 (13.2%) divided one meal into two meals, and 23 (12.6%) divided two meals into four meals. Among all patients, 8.5% had to reuse insulin aspart before dinner after the study. One patient with diarrhea and poor appetite experienced severe hypoglycemia. The rate of hypoglycemia was 3.76 events/patient-year. The daily insulin Aspart 30 dose was higher than the original insulin aspart dose (P = 0.001). Conclusions For patients with poorly controlled T2DM under the 1 + 1 regimen, switching to glargine+insulin aspart 30 before breakfast combined with exercise after dinner and dividing meals showed promising benefits.

It is not fully clarified whether insulin glargine, an analogue with a high affinity for insulin-like growth factor-1 receptor (IGF-1R), increases the risk for cancers that abundantly express IGF-1R such as breast cancer or some types of breast cancer. To gain insight into this issue, female Sprague–Dawley rats fed a high-fat diet were given the carcinogen N-methyl-N-nitrosourea and randomly assigned to vehicle (control), NPH (unmodified human insulin), glargine or detemir (n = 30 per treatment). Insulins were given subcutaneously (15 U/kg/day) 5 days a week. Mammary tumours were counted twice weekly, and after 6 weeks of treatment, extracted for analysis. None of the insulin-treated groups had increased mammary tumour incidence at any time compared with control. At 6 weeks, tumour multiplicity was increased with NPH or glargine (P < 0.05) and tended to be increased with detemir (P = 0.2); however, there was no difference among insulins (number of tumours per rat: control = 0.8 ± 0.1, NPH = 1.8 ± 0.3, glargine = 1.5 ± 0.4, detemir = 1.4 ± 0.4; number of tumours per tumour-bearing rat: control = 1.3 ± 0.1, NPH = 2.2 ± 0.4, glargine = 2.7 ± 0.5, detemir = 2.3 ± 0.5). IGF-1R expression in tumours was lower than that in Michigan Cancer Foundation-7 (MCF-7) cells, a cell line that shows greater proliferation with glargine than unmodified insulin. In rats, glargine was rapidly metabolised to M1 that does not have greater affinity for IGF-1R. In conclusion, in this model of oestrogen-dependent breast cancer in insulin-resistant rats, insulin and insulin analogues increased tumour multiplicity with no difference between insulin types.

Background: No data exist about the changes induced by the transition from first‐generation long‐acting insulins to second‐generation long‐acting analogues in the paediatric population. Objective: To assess changes in insulin/carbohydrate ratio (I:CHO) after the first 6 months of degludec therapy in a paediatric population with type 1 diabetes previously treated with glargine U100. Subjects: All patients treated with degludec under routine clinical practice conditions were retrospectively analysed. Methods: Nonprofit observational retrospective study. Changes during the follow‐up in mean CHO/I ratio were assessed using longitudinal linear models for repeated measures. Rate of hypoglycaemia, ketoacidosis and adverse events was evaluated. Results: Overall, 51 children (mean age 13.8 ± 4.6 years; mean diabetes duration 5.8 ± 3.9 years) started therapy with degludec in the period between April 2017 and April 2018. I:CHO ratio before starting degludec therapy significantly differed among the three meals, being the lowest at breakfast and the highest at dinner. After introducing degludec, I:CHO ratio at lunch (−1.29 95% CI −2.02;−0.57) and at dinner (−3.08 95% CI −4.35;−1.8) significantly decreased, while it slightly increased at breakfast (+1.37 95% CI 0.47;2.28). No episodes of severe hypoglycaemia, ketoacidosis and adverse event were recorded during 6 months. Conclusions: Our data show that the use of degludec is associated with a significant change in the I:CHO ratio at the different meals compared to the previous glargine therapy. This could derive from the flat and prolonged pharmacokinetic profile of degludec. This has important clinical implications for daily insulin dose adjustments. [ABSTRACT FROM AUTHOR]

Outcomes of insulin analogues in pediatric diabetes camps are poorly investigated; no data is available about insulin degludec (IDeg). Our aim was to assess impact of insulin therapy adopted by the participants to a 4-day diabetes camp held in 2017, hypothesizing a possible excess risk of hypoglycemia in patients treated with IDeg. Overall, 40 children with type 1 diabetes (mean age 13.4±3.0 years; 62.5% males) attended the camp (20.0% on continuous subcutaneous insulin infusion and 80.0% on multiple daily injections - MDI). Among children in MDI regimen, 71.9% were treated with IDeg as basal insulin and 28.1% with glargine U100 (IGlar). All patients used Lispro or Aspart as short-acting insulin. Daily plan of the camp included educational sessions, physical exercise, 3 main meals and 2 snacks. At the arrival, IGlar and short-acting insulin doses were revised according to existing guidelines, while IDeg dose was revised based on an empirical individualized approach. At the arrival, insulin doses were reduced in 22 participants (-19.4±10.5%), while doses were increased in 17 children (+17.8±12.7%), based on individual needs. No statistically significant between-group difference emerged in mean blood glucose and glucose variability. No excess risk of hypoglycemia was found in the IDeg group. The study suggests similar effectiveness and safety of different insulin schemes when associated with appropriate diabetes education and management, and flexible dose adjustments. Despite its longer halflife and the lack of a validated algorithm, IDeg was not associated with an excess risk of hypoglycemia. [ABSTRACT FROM AUTHOR]

Introduction: This study aimed to determine, in close to real-life conditions, the efficacy and safety of switching from any basal insulin to insulin glargine 300 U/mL (Gla-300) in patients with uncontrolled type 2 diabetes (T2D). Methods: This was an interventional, multicenter, single-arm, prospective study with a 24-week treatment phase. Adult patients with T2D treated with basal insulin with or without other antidiabetics, HbA1c > 7.5%, and fasting self-monitored blood glucose (F-SMBG) > 130 mg/dL (mean of three measures) at baseline were included. Insulin dose was titrated to reach F-SMBG 90–130 mg/dL. Efficacy and safety were assessed at 12 weeks (W12) and 24 weeks (W24). The main outcome parameter was HbA1c change between baseline and W24. Safety parameters included self-reported hypoglycemia (any type). Patients' satisfaction with the treatment was assessed by the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Results: A total of 140 patients were included and 137 were treated. Mean HbA1c decreased from 8.64% at baseline to 8.14% at W12 (mean difference [95% CI] − 0.51% [− 0.64; − 0.38]) and 8.01% at W24 (− 0.64% [− 0.81; − 0.46]). Target F-SMBG was reached in 35.0% of the patients at W12 and 38.4% at W24. The percentages of patients reaching HbA1c levels < 7.0%, < 7.5%, and < 8.0% at W24 were 11.4%, 29.5%, and 50.8%, respectively, while only 31.6% had an HbA1c value < 8.0% at baseline. HbA1c reduction was greater in patients with higher baseline levels. During the treatment phase, 46.0% of the participants had at least one hypoglycemia event; 31.4% documented symptomatic hypoglycemia, 2.2% severe hypoglycemia, and 12.2% nocturnal hypoglycemia. Treatment satisfaction increased by 20% between baseline and W24. Conclusion: These data, derived from close to real-life practice in France, confirm the reassuring results of randomized trials on the efficacy and safety of Gla-300. Trial Registration: EudraCT number 2015-002416-33. [ABSTRACT FROM AUTHOR]

Our aim was to investigate whether human insulin (HI) or insulin glargine treatment could promote the proliferation of thyroid cells and determine the association between type 2 diabetes and thyroid disease. Rats were treated with different doses of HI and insulin glargine. Plasma glucose and the phosphorylation levels of the insulin receptor (IR), insulin-like growth factor 1 receptor (IGF-1R), protein kinase B (Akt), and extracellular signal-regulated kinase 1/2 (ERK1/2) were measured. A total of 105 rats were randomly assigned to three groups as follows: control group, HI group, and glargine group. Both drugs promoted the phosphorylation of IR, Akt, and ERK1/2 in a dose-dependent manner (p < 0.05), and the effect of glargine persisted for longer period. Treatment with ultra-therapeutic doses of HI or glargine (p < 0.05) increased the expression of Ki-67 in thyroid cells. The results demonstrated that therapeutic doses of glargine have a longer-lasting hypoglycemic control than HI. Based on the results, HI or glargine did not stimulate thyroid cell proliferation at therapeutic doses, but high doses did.

Aim: This non-interventional observational study aimed to describe the clinical outcomes of patients with T2DM treated with Gla-300 during the period of Ramadan., Background: Type 2 diabetes mellitus (T2DM) patients who decide to fast during the holy month of Ramadan face several challenges in achieving glycemic control without increasing the risk of hypoglycemia. Insulin glargine-300 (Gla-300) has well-established safety and efficacy in improving glycemic control in multiple randomized clinical trials (RCTs). However, limited evidence is available regarding its safety and effectiveness during fasting., Objective: The objective of this study was to assess the safety and clinical outcomes of insulin glargine-300 (Gla-300) in T2DM patients before, during, and after Ramadan., Methods: We conducted a prospective, observational, non-comparative, multicenter study on patients with T2DM currently treated with Gla-300 who planned to fast and continue on Gla-300 during Ramadan in four countries (Egypt, Jordan, Lebanon, and Turkey). The study outcomes included the change in glycemic parameters and incidence of hypoglycemia before, during, and after Ramadan., Results: One hundred and forty T2DM patients were included. Nearly 61% of the included patients had a duration of diabetes of <10 years. The mean Gla-300 daily doses during the pre-Ramadan, Ramadan, and post-Ramadan periods were 22.2 ±7.4, 20.4 ±7.5, and 22.5 ±4.7 IU, respectively. The mean change values from pre-Ramadan to Ramadan and post-Ramadan were -1.7 ±6.9 IU and 0.5 ±4.7 IU, respectively, among the included patients. The mean HbA1c decreased during the study period initiating from 7.9% ±1.4% pre-Ramadan to 6.9% ±0.4% post-Ramadan. The overall HBA1c target value was 6.9% ±0.4%, while the HbA1c target was achieved by 29 patients (21.9%). The mean fasting blood glucose (FPG) showed a reduction from baseline value in the post-Ramadan period by -0.9 ±2.3 mmol/L. Five patients (3.57%) had symptomatic documented hypoglycemia during Ramadan, and none was considered to have severe hypoglycemia., Conclusion: Our study showed that insulin Gla-300 maintained the glycemic control of T2DM patients who decided to fast during the holy month of Ramadan without increasing the risk of hypoglycemia. Regular self-monitoring of blood glucose levels during Ramadan is highly recommended to avoid possible complications., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)