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Abstract
Objective: The aim of this research is to determine efficacy and safety of repaglinide alone and in combination with metformin in Chinese subjects with type 2 diabetes naive to oral antidiabetes therapy.
Methods: A 16-week, open-label, randomized, active-controlled, parallel-group trial was carried out. Subjects were randomized (1:1) to repaglinide 1 mg t.i.d. (maximum dose, 4 mg t.i.d.) or repaglinide plus metformin 1 mg/500 mg t.i.d. (maximum dose, 4 mg/500 mg t.i.d.). Eligible subjects (18 – 75 years old) had type 2 diabetes, A1C > 8.5%, BMI ≤ 35 kg/m2, and were naive to oral antidiabetes agents.
Results: The primary outcome was A1C reduction. Secondary end points included fasting plasma glucose (FPG), 2-h postprandial glucose (PPG), and 7-point plasma glucose. Baseline characteristics (repaglinide/metformin, n = 218; repaglinide-only, n = 214) were similar between groups. Mean A1C reduction (± SD) was 4.51 ± 1.64% (combination) and 4.05 ± 1.59% (monotherapy). Estimated mean treatment difference for repaglinide/metformin versus repaglinide-only was -0.30% (95% CI -0.49 to -0.11; p < 0.01). Combination treatment demonstrated significant improvements versus monotherapy in FPG, 7-point plasma glucose, and lunchtime and dinnertime 2-h PPG (all p < 0.05). Hypoglycemia rates were 2.04 (combination) versus 1.35 (monotherapy) events/subject-year (p = 0.058). Adverse events were comparable between groups.
Conclusions: Repaglinide plus metformin and repaglinide alone provided significant improvements in glycemic control and were well tolerated in Chinese patients naive to treatment with oral antidiabetes agents. Combination therapy with repaglinide plus metformin showed superiority to repaglinide monotherapy in this population. Limitations of this study are that subjects were newly diagnosed and had high mean baseline A1C, which may affect generalizability of results.
Acknowledgements
The authors are indebted to the following principal investigators and their staff who participated in this clinical trial: Ruifang Bu, Shiwei Cui, Jixiang Dong, Bo Feng, Hui Jin, Chengjiang Li, Hong Li, Jianying Liu, Libin Liu, Wei Liu, Jianhua Ma, Guang Ning, Feixia Shen, Qing Su, Jiao Sun, Weiqing Wang, Guoting Wu, and Tao Yang. The authors also thank Nicole Cooper of MedVal Scientific Information Services, LLC for providing medical writing and editorial assistance. Data from this paper were presented, in part, at the 46th Annual Meeting of the European Association for the Study of Diabetes, 20 – 24 September 2010, Stockholm, Sweden.