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

R Ravi Shankar, Yuqian Bao, Ping Han, Ji Hu, Jianhua Ma, Yongde Peng, Fan Wu, Lei Xu, Samuel S Engel, Weiping Jia, R Ravi Shankar, Yuqian Bao, Ping Han, Ji Hu, Jianhua Ma, Yongde Peng, Fan Wu, Lei Xu, Samuel S Engel, Weiping Jia

Abstract

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 <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.

Keywords: Insulin; Sitagliptin; Type 2 diabetes mellitus.

© 2016 Merck Sharp & Dohme Corp. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Figures

Figure 1
Figure 1
Patient disposition.
Figure 2
Figure 2
Change from baseline in HbA1c (%) over time. LS, least squares; SE, standard error of the mean.

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