Objective: To evaluate the clinical efficacy and tolerability of pioglitazone monotherapy or in combination with sulfonylurea therapy in the treatment of chinese patients with type 2 diabetes.
Methods: This 12-week study involved 117 patients with type 2 diabetes whose blood glucose was uncontrolled on a stable regimen of diet or oral sulfonylureas for at least 3 months (fasting blood glucose (FBG) 7.8-15.0 mmol/L; postprandial blood glucose (PBG) >11.1 mmol/L)). The patients received once daily pioglitazone 30 mg plus diet (Group PIO-mono) or sulfonylurea (Group PIO-SU). The fasting and postprandial plasma glucose, serum insulin, C-peptid, lipid profile, free fatty acids (FFAs) levels were measured at baseline and every 4 weeks after treatment. Results All patients showed significant improvement in glycemic control over baseline. There were 1.64%, 2.1 mmol/L, 5.2 mmol/L decrease from baseline HbA1c, FBG and PBG levels in the Group PIO-mono and 1.06%, 2.3 mmol/L, 5.4 mmol/L decrease in the Group PIO-SU after 12 weeks treatment, respectivley. Both groups experienced slight decreases in C-peptide and insulin concentrations during 12 weeks period. Both groups showed mean percent decreases in triglyceride and FFA levels(21.8% and 20.7% for PIO-mono, 22.2% and 14.5 for PIO-SU) and increases in HDL-C (21.4% for PIO-mono and 30.8% for PIO-SU), compared with baseline. pioglitazone was well tolerated.
Conclusion: In patients with type 2 diabetes, pioglitazone monotherapy or in combination with sulfonylurea therapy significantly improves HbA1c, FBG and PBG levels and reserves the beta-cell function with beneficial effects on serum triglyceride and HDL-C levels.