Search

Introduction To evaluate efficacy and safety data of dulaglutide in Chinese patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with 1–2 oral antihyperglycemic medications (OAMs). Methods This is a subgroup analysis of a phase 3, open-label, randomized, parallel-arm, 52-week study in Chinese patients aged ≥ 18 years with T2DM who had inadequate glycemic control with OAMs (glycated hemoglobin [HbA1c] ≥ 7.0% and ≤ 11.0%). The primary endpoint was assessment of the noninferiority of dulaglutide 1.5 mg as measured by change in HbA1c, compared with insulin glargine (glargine), using a 0.4% noninferiority margin at week 26. Results A total of 607 patients from China were randomized 1:1:1 to once-weekly dulaglutide 1.5 or 0.75 mg or once-daily glargine. At week 26, the least squares mean (LSM) change from baseline in HbA1c was greater with dulaglutide 1.5 mg (− 1.67%) and dulaglutide 0.75 mg (− 1.31%) compared with glargine (− 1.11%). The LSM (95% confidence interval) for the difference of dulaglutide 1.5 mg and 0.75 mg vs glargine was − 0.56% (− 0.75 to − 0.37) and − 0.20% (− 0.39 to − 0.01), respectively. Both doses of dulaglutide were noninferior and superior to glargine at 26 weeks and 52 weeks (two-sided P value

Aims To compare the efficacy and safety of combination of vildagliptin and metformin therapy with metformin uptitration in Chinese patients with type 2 diabetes (T2DM) inadequately controlled with low-dose metformin. Methods In this 24-week prospective, randomized, multicentre, open-label study, patients with T2DM inadequately controlled with metformin ≤1000 mg daily were divided 1 : 1 : 1 : 1 into four prespecified subgroups based on age and body mass index (BMI). Patients in each subgroup were randomized 5 : 1 to receive either vildagliptin (50 mg twice daily) plus metformin [500 mg twice daily; vildagliptin and low-dose metformin (VLDM) group] or metformin uptitration [1000 mg twice daily; high-dose metformin (HDM) group]. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline at week 24. The key secondary endpoints included percentage of patients achieving target HbA1c without adverse gastrointestinal (GI) events and mean change in fasting plasma glucose (FPG) from baseline to week 24. Results A total of 3084 patients were randomized. HbA1c reduction of 0.54% at week 24 in the VLDM group was non-inferior and statistically superior compared with 0.40% in the HDM group (P < 0.0001). VLDM's non-inferiority to HDM was confirmed in the four subgroups and its superiority was shown for all subgroups (p < 0.05) except for the subgroup of patients aged

Baseline and on-treatment characteristics, including age, obesity, calcium intake, and bone turnover markers, may predict the bone mineral density (BMD) response in women with postmenopausal osteoporosis (PMO) to 1 to 2 years of antiresorptive therapy and/or vitamin D supplementation. This study aimed to explore clinical characteristics associated with 12-month BMD improvement in Chinese women with postmenopausal osteoporosis (PMO). In this post hoc analysis of a previous phase 3 multicenter, randomized controlled trial, Chinese PMO women who were treated with once weekly alendronate 70 mg/vitamin D3 5600 IU (ALN/D5600) or once daily calcitriol 0.25 mcg, and had measurements of 1-year lumbar spine BMD (LS-BMD) and on-treatment bone turnover markers (BTMs) were included in the analysis. In Chinese PMO patients on ALN/D5600, 1-year LS-BMD change was negatively correlated with age (β = −0.00084, P

Background and Aim: Nonalcoholic fatty liver disease (NAFLD) is considered to be the liver component of metabolic syndrome. However, the impact of NAFLD on metabolic syndrome is unclear. The aim of this study was to explore the influence of NAFLD on the development of metabolic disorders. Methods: Patients with NAFLD and an age, sex, and occupation-matched control group were recruited from employees of Bao-Steel Group (Shanghai, China) who had received medical check-ups biennially between 1995 and 2002. Anthropometric and laboratory data, and incidence of metabolic disorders were assessed at baseline and at follow-up of at least 4 years. SPSS 11.5 was used for statistical analysis. Results: The study consisted of 358 patients (326 men and 32 women) and 788 matched controls (711 men and 77 women) with a similar mean age of 39.0 years and median follow-up of 6 years. At the end of follow-up, incidence of obesity (47.6% vs 19.5%), hypertension (69.6% vs 16.3%), hypertriglyceridemia (39.1% vs 16.3%), hypercholesterolemia (24.5% vs 17.3%), impaired fasting glucose (IFG) (25.1% vs 11.6%), diabetes mellitus (20.3% vs 5.2%) and multiple metabolic disorders (MMD) (56.3% vs 16.3%) were significantly higher in the fatty liver group than the control group. Interestingly, the mean alanine aminotransferase (ALT) level in patients with fatty liver significantly decreased at follow-up compared with baseline (28.56 ± 18.86 vs 31.51 ± 18.34 U/L, P

Background and Aim: To evaluate changes in the prevalence rates of ultrasonographic fatty liver (FL) in a specific population. Methods: An analysis of the medical records of BaoSteel Group (Shanghai, China) employees was done to evaluate the prevalence of FL in this population, in which health examinations were performed biennially between 1995 and 2002. Results: The study reviewed a database of 59 131 employees, of which 27.1% received medical check-ups four times within the study period, 26.6% three times, and 24.0% twice. The prevalence rates of obesity and metabolic disorders were high at baseline and increased significantly with time. The prevalence of ultrasonographic FL increased from 3.87% to 14.04% in the overall population, while there was an increase from 4.44% to 14.64% in men and 1.56% to 11.37% in women over the 6-year study period. Increased rates of FL were also noted, from 25.88% to 51.39%, among patients with elevated serum alanine aminotransferase (ALT) levels (>40 U/L). The highest overall prevalence rates of FL were found in individuals aged 50–60 years, with all age-associated prevalence significantly higher in males than females. Conclusion: The prevalence of FL increased rapidly over the study period with increased rates of obesity and metabolic disorders; FL is becoming a major cause of abnormal ALT levels in the specific population.

To assess the design and the Mainland China subgroup baseline characteristics of the study to evaluate the efficacy and safety of alogliptin versus placebo in subjects with type 2 diabetes (T2DM) as monotherapy, add-on to metformin or add-on to pioglitazone.This was a multi-center, randomized, double-blind, placebo-controlled, 16-week study comparing alogliptin (ALO, 25 mg, 1/d) versus placebo (PLA) as monotherapy (A), add-on to metformin (B) or add-on to pioglitazone ± metformin (C). The T2DM subjects with glycosylated hemoglobin A1c(HbA1c) between 7% and 10% and aged between 18 years and 75 years were enrolled and randomized to the alogliptin group and the placebo group in 1: 1 ratio with 16 weeks treatment. All patients were followed up every 4 weeks. The safety endpoints consisted of the incidence of hypoglycemia and other adverse events.A total of 491 patients were enrolled in the Mainland China subgroup of the study (181 in group A, 186 in group B and 124 in group C). In each treatment group, the baseline characteristics including age, gender, body mass index, diabetes duration, HbA1c, fasting plasma glucose, body weight, daily dosage of metformin and daily dosage of pioglitazone were all well balanced.The demographic data, medical history, glycemic profile and treatment regimen at baseline in Mainland China subgroup are well balanced. The result of this study will provide the clinical evidence for the use of alogliptin in Chinese T2DM patients.

To investigate the integrated effects of adipocytes on rat beta-cells, differentiated 3T3L1 adipocytes and rat islet cells co-culture system was established.There were two groups: control group (SD rat islet cells) and co-culture group (islet cells and 3T3L1 adipocytes coculture system). Islet cells were obtained for determination of (1) insulin secretion and insulin content; (2) mRNA expressions of GLUT2, GCK and Kir6.2; (3) protein expressions of IR-beta, IRS-1 and their tyrosine phosphorylation level.(1) At low glucose, insulin secretion of co-culture group increased compared with that of control group (0.79 +/- 0.35) ng x h(-1) x ml(-1) islet vs. (0.38 +/- 0.09) ng x h(-1) x ml(-1) x islet, P = 0.028. At high glucose, insulin secretion of those two groups was almost at the same level (P = 0.760). Compared with control group (2.84 +/- 0.92), stimulation index (SI, insulin release at high glucose/ low glucose) of co-culture system decreased to (1.57 +/- 0.61, P = 0.04). And the insulin content of the both groups was almost at the same level (P = 0.102). (2) The mRNA of GCK, GLUT2 and Kir6.2 in co-culture group downregulated to (0.27 +/- 0.11, P = 0.01), (0.34 +/- 0.24, P = 0.009) and (0.41 +/- 0.09, P = 0.003) compared with control group (mRNA = 1). (3) The protein levels of IR-beta, IRS-1 and their tyrosine phosphorylation decreased in co-culture system.3T3L1 adipocytes are involved in beta-cell dysfunction, which may facilitate the development of type 2 diabetes. The effects may be mediated by multiple pathways, which include downregulation of GSIS related gene expressions and suppression of islet cell insulin signaling.

To compare the clinical efficacy and safety of domestic orlistat and imported orlistat in Chinese overweight and obese patients.In a randomized, double-blinded and positive-controlled study, 228 adults (BMI 24-40 kg/m(2)) evaluated at seven research centers were randomized to receive domestic orlistat or imported orlistat 120 mg 3 times a day with an energy-controlled diet for 24 weeks.After 24 weeks, domestic orlistat treated patients got significant weight-loss (5.0 +/- 3.7) kg, which was comparable with that of imported orlistat treated patients (4.5 +/- 3.5) kg (P = 0.3922). Compared with the findings before treatment, there was significant decrease of systolic blood pressure (4.4 +/- 11.5) mm Hg (1 mm Hg = 0.133 kPa) and serum levels of TC (0.54 +/- 0.79) mmol/L and LDL-C (0.32 +/- 0.64) mmol/L in the domestic orlistat treated group (compared with levels of baseline, P0.0001). There was no significant difference between the two groups in the changes of blood pressure and lipid levels. Both groups had similar adverse event profiles, most of which were mild and transient gastrointestinal events. There were no serious adverse events in both groups.Domestic orlistat combined with a light low-energy diet promoted significant weight loss, which was comparable with that of imported orlistat after 24 weeks of treatment. There was also improvement in blood pressure and serum levels of TC and LDL-C. Domestic orlistat was as effective and safe as imported orlistat in the treatment of obesity.

To set up the reference value of serum glycated albumin (GA) in Chinese for using in clinical practice through a multi-center clinical trial.Three hundred and eighty individuals with normal weight and normal glucose regulation, including 183 males and 197 females ranging from 20 to 69 years, were recruited from 10 hospitals in China Serum GA levels were measured with liquid enzymatic method.(1) The GA level of the 380 subjects was (14.5 +/- 1.9)%. When dividing these subjects by age into 3 subgroups, there was no difference in the GA levels among the 3 subgroups (P0.05). Compared with the women, the men had higher GA level in the first subgroup aging from 20 to 39 (P = 0.028). However, no significant difference was detected after adjusting with BMI as confounder. (2) When dividing those subjects by BMI into 3 subgroups, with BMI ranging from 18.5-20.9 kg/m2 21.0-22.9 kg/m2 and 23.0-24.9 kg/m2 respectively, we came to the following results: for men, there was no difference in the GA levels among the 3 subgroups (P0.05), but for women, the GA level of the first subgroup was higher than that of the second subgroup (P = 0.024). (3) The level of GA in the 2.5th to 97.5th percentile was 10.8%-17.1%. (4) Sixty normal subjects were chosen to repeat evaluation of GA levels after 2-3 weeks and the GA levels were of no difference (P0.05).The normal range of serum GA for the Chinese population could be suggested at 11%-17%.

Non-alcoholic fatty liver disease (NAFLD), as conventionally recognized, is a metabolic disorder largely confined to residents of affluent industrialized Western countries. However, obesity and insulin resistance are not restricted to the West, as witnessed by their increasingly universal distribution. In particular, there has been an upsurge in metabolic syndrome in the Asia-Pacific region, although there are critical differences in the extent of adiposity between Eastern and Western populations.An English-language literature search using PubMed (1999-2007) on obesity, metabolic syndrome and NAFLD, focusing on Asian definitions and Asian studies.NAFLD appears to be of long-standing insulin resistance and likely represents the hepatic manifestation of the metabolic syndrome. With insulin resistance as a common factor, the disease is associated with atherosclerosis and cardiovascular risk. All features of the metabolic syndrome and related events are assessed for practical management of NAFLD, although the criteria for the diagnosis of obesity and central obesity differ across racial groups.The increasing prevalence of obesity, coupled with diabetes, dyslipidemia, hypertension and ultimately metabolic syndrome, puts a very large population at risk of developing NAFLD in the coming decades. The simultaneous identification and appropriate treatment of the components of metabolic syndrome are crucial to reduce hepatic as well as cardiovascular morbidity and mortality.

To evaluate changes in the prevalence rates of ultrasonographic fatty liver (FL) in a specific population.An analysis of the medical records of BaoSteel Group (Shanghai, China) employees was done to evaluate the prevalence of FL in this population, in which health examinations were performed biennially between 1995 and 2002.The study reviewed a database of 59 131 employees, of which 27.1% received medical check-ups four times within the study period, 26.6% three times, and 24.0% twice. The prevalence rates of obesity and metabolic disorders were high at baseline and increased significantly with time. The prevalence of ultrasonographic FL increased from 3.87% to 14.04% in the overall population, while there was an increase from 4.44% to 14.64% in men and 1.56% to 11.37% in women over the 6-year study period. Increased rates of FL were also noted, from 25.88% to 51.39%, among patients with elevated serum alanine aminotransferase (ALT) levels (40 U/L). The highest overall prevalence rates of FL were found in individuals aged 50-60 years, with all age-associated prevalence significantly higher in males than females.The prevalence of FL increased rapidly over the study period with increased rates of obesity and metabolic disorders; FL is becoming a major cause of abnormal ALT levels in the specific population.

Background and aim Limitations of the currently recommended stepwise treatment pathway for type 2 diabetes mellitus (T2DM), especially the failure of monotherapies to maintain good glycemic control, have prompted use of early, more aggressive combination therapies. The VISION study is designed to explore the efficacy and safety of vildagliptin as an add-on to metformin therapy compared with up-titration of metformin monotherapy in Chinese patients with T2DM. Methods VISION, a 24-week, phase 4, prospective, randomized, multicenter, open-label, parallel-group study, will include 3312 Chinese T2DM patients aged ≥18 years who are inadequately controlled (6.5% >HbA1c ≤9%) by metformin (750–1000 mg/day). Eligible patients will be randomized to receive either vildagliptin plus metformin or up-titration of metformin monotherapy (5:1). Patients will also be subgrouped (1:1:1:1) based on their age and body mass index (BMI)