OBJECTIVE: We designed a multi-center, double-blind, randomized, parallel, with metformin controlled clinical trial to evaluate the efficacy and safety of low dose rosiglitazone combined with sulphonylurea therapy in type 2 diabetic patients who were inadequately controlled with sulphonylurea alone. METHODS: Patients were treated with 4 mg rosiglitazone once daily plus sulphonylurea (test group) or 0.5 g metformin twice daily plus sulphonylurea (control group) for 12 weeks. The mean levels of HbA(1c), fasting and postprandial plasmaglucose were recorded and compared between the two groups. RESULTS: The mean levels of HbA(1c) decreased by 1.09% and 0.95% in the test group (n = 102) and control group (n = 96) respectively. Fasting and postprandial plasma glucose levels in the test group decreased by 25.0% and 35.6%, and in the control group, decreased by 17.7% and 23.8% as compared with the baseline (both P < 0.01). No liver damage was found. CONCLUSION: Combination treatment of rosiglitazone and sulphonylurea can effectively improve glycemic control in type 2 diabetic patients inadequately controlled with sulphonylurea alone.
RCT Entities:
OBJECTIVE: We designed a multi-center, double-blind, randomized, parallel, with metformin controlled clinical trial to evaluate the efficacy and safety of low dose rosiglitazone combined with sulphonylurea therapy in type 2 diabeticpatients who were inadequately controlled with sulphonylurea alone. METHODS:Patients were treated with 4 mg rosiglitazone once daily plus sulphonylurea (test group) or 0.5 g metformin twice daily plus sulphonylurea (control group) for 12 weeks. The mean levels of HbA(1c), fasting and postprandial plasma glucose were recorded and compared between the two groups. RESULTS: The mean levels of HbA(1c) decreased by 1.09% and 0.95% in the test group (n = 102) and control group (n = 96) respectively. Fasting and postprandial plasma glucose levels in the test group decreased by 25.0% and 35.6%, and in the control group, decreased by 17.7% and 23.8% as compared with the baseline (both P < 0.01). No liver damage was found. CONCLUSION: Combination treatment of rosiglitazone and sulphonylurea can effectively improve glycemic control in type 2 diabeticpatients inadequately controlled with sulphonylurea alone.