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糖尿病研究新进展讲稿
* OP6 Background and aims: Type 2 diabetes is a heterogeneous disorder due to interaction of impaired early insulin secretion and peripheral insulin resistance. Starting from this point of view, the combination between two drugs able to restore respectively early insulin secretion and insulin sensitivity, such as Repaglinide and Metformin, could be a good therapeutical option, fitting with the pathophysiological aspects of Type 2 diabetes. The aim of present study was to compare the efficacy and safety of Repaglinide in combination with Metformin in type 2 subjects not well controlled with sulphanylureas or metformin in monotherapy. In order to set the best combination between Repaglinide and Metformin, we compared three different regimens: Repaglinide 1 mg/meal + Metformin 1500 mg dinnertime (Group 1); Repaglinide 1 mg/meal + Metformin 1000 mg dinnertime (Group 2); Repaglinide 1 mg/meal + Metformin 500 mg/meal (Group 3). Metformin dose was unmodified through the study instead of Repaglinide whose dose could be increased at 2 mg/meal in case of FPG140 mg/dl after first two weeks from randomization. Materials and methods: A total of 102 Type 2 diabetic subjects not well controlled in OHA monotherapy were randomized. Three groups were well balanced at baseline for sample size (34, 33 and 35 respectively in Group 1, 2 and 3), age (56,2, 54,3 and 57.3 years respectively in Group 1,2 and 3), duration of disease (6,2, 6,8 and 6,7 years respectively in Group 1,2 and 3), BMI (29.5, 29.4, 28.9 Kg/m?respectively in Group 1,2 and 3) and HbA1c (8.5, 8.2 and 8.4% respectively in Group 1,2 and 3). 90 subjects ended the 16 weeks study treatment period; 29 in Group 1, 27 in Group 2 and 34 in Group 3. Parameters assessed were HbA1c, FPG, blood glucose profile, Repaglinide requirements, lipid profile, change in body weight and hypoglycaemic episodes. Results: HbA1c values during the study decreased in each Group (- 0.95?.33%; p0.001 in Group 1; -0.78?.40%; p=0.0056 in Group 2; - 1.01
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