OBJECTIVEWe 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.

METHODSPatients 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.

RESULTSThe 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.

CONCLUSIONCombination treatment of rosiglitazone and sulphonylurea can effectively improve glycemic control in type 2 diabetic patients inadequately controlled with sulphonylurea alone.

Adult ; Aged ; Blood Glucose ; analysis ; Diabetes Mellitus, Type 2 ; drug therapy ; Double-Blind Method ; Drug Therapy, Combination ; Humans ; Hypoglycemic Agents ; administration & dosage ; Metformin ; administration & dosage ; Middle Aged ; Sulfonylurea Compounds ; administration & dosage ; Thiazoles ; administration & dosage ; Thiazolidinediones