Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes

• Published in: Journal of diabetes investigation 2017-05, Vol.8 (3), p.321-329
• Main Authors: Shankar, R Ravi, Bao, Yuqian, Han, Ping, Hu, Ji, Ma, Jianhua, Peng, Yongde, Wu, Fan, Xu, Lei, Engel, Samuel S, Jia, Weiping
• Format: Article
• Language: English
• Subjects: Antidiabetics; Asian Continental Ancestry Group; China; Clinical Trial; Diabetes; Diabetes mellitus; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Fasting; Female; Glucose; Glycated Hemoglobin A - analysis; Hemoglobin; Humans; Hypoglycemia; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Insulin; Insulin - therapeutic use; Male; Metformin; Metformin - therapeutic use; Middle Aged; Sitagliptin; Sitagliptin Phosphate - adverse effects; Sitagliptin Phosphate - therapeutic use; Treatment Outcome; Type 2 diabetes mellitus
• ISSN: 2040-1116; 2040-1124
• DOI: 10.1111/jdi.12585

Introduction We evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin. Materials and Methods A total of 467 patients with inadequate glycemic control on insulin (glycated hemoglobin [HbA1c] ≥7.5% and ≤11%) were randomized 1:1 to receive sitagliptin 100 mg once daily or a matching placebo for 24 weeks. Randomization was stratified based on metformin use (on or not on metformin) and type of insulin (pre‐mixed vs intermediate‐/long‐acting) at screening. The primary end‐point was the change from baseline at week 24 in HbA1c. Results The addition of sitagliptin led to a significantly (P < 0.001) greater week 24 HbA1c reduction (0.7%) compared with the reduction (0.3%) with placebo. A significantly (P = 0.013) greater proportion of patients taking sitagliptin (16%) had an HbA1c of