Background: The present subanalysis of the Study of Once Daily Levemir (SOLVE) study was to evaluate the safety and efficacy of once-daily insulin detemir as add-on to oral antidiabetic drugs (OADs) in Chinese type 2 diabetes patients according to body mass index in a real-life setting.
Methods: In all, 3272 eligible patients who were treated with diet, exercise, and one or more OAD were prescribed once-daily insulin detemir by their physician according to routine clinical practice and were followed-up for 24 weeks. The incidence of serious adverse reactions (SADRs), including major hypoglycemia, was the primary endpoint. Subanalyses were performed on patients in the following BMI groups: normal weight (BMI < 25 kg/m2); overweight (25 ≤ BMI < 30 kg/m2); and obese (BMI ≥ 30 kg/m2).
Results: No SADRs were reported during the study. Significant improvements in glycemic levels were observed in all subgroups. For normal weight, overweight, and obese patients, the mean change in HbA1c (%/[mmol/mol]) was -1.26/-14, -1.09/-12, and -1.06/-12, respectively. The mean change in fasting plasma glucose in normal weight, overweight, and obese patients was -2.77, -2.57, and -2.71 mmol/L, respectively. Slight weight gain (0.25 kg), slight weight loss (-0.36 kg), and weight loss (-1.32 kg) were observed in the normal weight, overweight, and obese patients, respectively (P < 0.001). Linear regression analysis revealed a negative relationship between weight change and baseline BMI (slope = -0.16; P < 0.001).
Conclusions: Once-daily insulin detemir as add-on to OADs in Chinese patients with type 2 diabetes showed effective glycemic control and a low risk of hypoglycemia. Weight-neutral effects were observed in different BMI subgroups.
Keywords: body mass index; body weight; insulin detemir; type 2 diabetes mellitus; 关键词：体重指数，体重，地特胰岛素，2型糖尿病.
© 2014 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.