Open AccessSitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes
Author(s) -
Shankar R Ravi,
Bao Yuqian,
Han Ping,
Hu Ji,
Ma Jianhua,
Peng Yongde,
Wu Fan,
Xu Lei,
Engel Samuel S,
Jia Weiping
Publication year - 2017
Publication title -
journal of diabetes investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.089
H-Index - 50
eISSN - 2040-1124
pISSN - 2040-1116
DOI - 10.1111/jdi.12585
Subject(s) - sitagliptin , medicine , metformin , placebo , tolerability , type 2 diabetes , glycated hemoglobin , dipeptidyl peptidase 4 inhibitor , type 2 diabetes mellitus , sitagliptin phosphate , endocrinology , insulin , diabetes mellitus , glycemic , gastroenterology , adverse effect , alternative medicine , pathology
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 <7.0% at week 24 compared with placebo (8%). The addition of sitagliptin significantly ( P < 0.001) reduced 2‐h post‐meal glucose by 26.5 mg/ dL (1.5 mmol/L) relative to placebo. Reductions from baseline in fasting plasma glucose were observed in both the sitagliptin (14.4 mg/ dL reduction) and placebo (10.7 mg/ dL reduction) groups; the between‐group difference was not significant. A total of 64 (27.4%) patients taking sitagliptin and 51 (21.9%) taking placebo experienced adverse events of hypoglycemia (symptomatic or asymptomatic). Neither group had a significant change from baseline in bodyweight. Conclusions After 24 weeks, sitagliptin added to stable insulin therapy (±metformin) was generally well tolerated and improved glycemic control in Chinese patients with type 2 diabetes mellitus.