Randomized trial assessing the safety and efficacy of sitagliptin in Chinese patients with type 2 diabetes mellitus inadequately controlled on sulfonylurea alone or combined with metformin: 在磺脲类药物单用或与二甲双胍联用血糖控制不佳的中国2型糖尿病患者中西格列汀的安全性和有效性评估:一项随机对照研究. (13th September 2016)

• Record Type: Journal Article
• Authors: Ba, Jianming; Han, Ping; Yuan, Guoyue; Mo, Zhaohui; Pan, Changyu; Wu, Fan; Xu, Lei; Hanson, Mary E.; Engel, Samuel S.; Shankar, R. Ravi
• Is Part Of: Journal of diabetes. Volume 9:Number 7(2017)
• Page Start: 667
• Page End: 676
• Publication Date: 2016-09-13
• Subjects: China -- HbA1c -- hypoglycemia -- sitagliptin -- sulfonylurea; 中国 -- HbA1c -- 低血糖 -- 西格列汀 -- 磺脲类; Diabetes -- Periodicals; 618.3646005
• DOI: 10.1111/1753-0407.12456
• Languages: English
• ISSNs: 1753-0393

Abstract

Abstract: Background: Type 2 diabetes mellitus (T2DM) is a significant burden in China, where approximately 114 million patients have been diagnosed with diabetes. Chinese patients present with prominent β‐cell failure, with resulting deficiency in insulin secretion, particularly early phase insulin secretion leading to postprandial hyperglycemia. Sitagliptin, a selective once‐daily oral dipeptidyl peptidase‐4 inhibitor, has been shown to improve glycemic control as monotherapy and in combination with other antihyperglycemic agents, including sulfonylureas and metformin. Methods: This was a multicenter randomized double‐blind placebo‐controlled study conducted in China. The study assessed the safety and efficacy of the addition of sitagliptin 100 mg once daily versus placebo on changes from baseline at Week 24 in HbA1c, fasting plasma glucose (FPG) and 2‐h post‐meal glucose (PMG). Patients were aged 18–79 years, had T2DM with inadequate glycemic control, and were taking a sulfonylurea, with or without metformin. Results: After 24 weeks, sitagliptin reduced HbA1c, FPG, and 2‐h PMG significantly more than placebo (between‐treatment differences: −0.61 %, −16.8 mg/dL, and −32.9 mg/dL, respectively; P < 0.001 for all). The addition of sitagliptin was generally well tolerated, with a comparable incidence of adverse events and drug‐related adverse events in both treatment groups. The sitagliptin group had a higher incidence of symptomatic hypoglycemia than the placebo group (25/248 [10.1 %] vs 13/249 [5.2 %], respectively; P = 0.042). Conclusions: Sitagliptin 100 mg once daily significantly improved glycemic control in Chinese patients with T2DM who had inadequate glycemic control with sulfonylurea, with or without metformin therapy. The addition of sitagliptin was generally well tolerated. (clinicaltrials.gov : NCT01590771). Abstract : Mean HbA1c over time for sitagliptin 100 mg ( n = 231–248) and placebo ( n = 213–249) in the entire study cohort. Data are the mean ± SE. Highlights The addition of sitagliptin resulted in significantly greater glycemic control versus placebo among Chinese patients with type 2 diabetes mellitus who were inadequately controlled on a sulfonylurea, with or without metformin. The safety profile was generally consistent with that observed in similarly designed global trials. The present study was conducted in a Chinese population and yielded results generally consistent with a similarly designed multinational study. Together, these results demonstrate the consistency of effect of sitagliptin across multiple populations.