Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes

Abstract

Background Type 2 diabetes is a growing problem in Mexico. The present study was undertaken to evaluate the efficacy and safety of rosiglitazone 2 mg or 4 mg twice daily (bd) in combination with metformin 2.5 g/day in Mexican patients whose type 2 diabetes was inadequately controlled with metformin alone. Methods This randomized, double‐blind, placebo‐controlled study was conducted at four centers in Mexico. A total of 116 patients were randomized to metformin 2.5 g/day plus placebo (n=39), metformin 2.5 g/day plus rosiglitazone 2 mg bd (n=37), or metformin 2.5 g/day plus rosiglitazone 4 mg bd (n=40) for 26 weeks. Results Mean hemoglobin A_1c (HbA_1c) levels decreased significantly from baseline to Week 26 in the rosiglitazone 2 mg bd (−0.7%; p=0.0052) and 4 mg bd (−1.2%; p=0.0008) groups, but increased in the placebo group (+0.3%; p=0.2651). Mean fasting plasma glucose and fructosamine levels also improved significantly with metformin plus rosiglitazone therapy in a dose‐ordered manner compared with placebo (p≤0.0019 and p=0.0006, respectively). C‐peptide and immunoreactive insulin levels were decreased from baseline in both rosiglitazone groups. Although mean increases in total cholesterol, low‐density lipoprotein (LDL)‐cholesterol, and high‐density lipoprotein (HDL)‐cholesterol were observed in the rosiglitazone groups, the total cholesterol:HDL‐cholesterol ratio remained unchanged. The proportion of patients with one or more adverse events was similar across all three groups. There were no cases of hepatotoxicity. Conclusion Addition of rosiglitazone 2 mg bd and 4 mg bd to metformin therapy improved glycemic control in Mexican patients whose type 2 diabetes was inadequately controlled by metformin alone. Furthermore, the combination of rosiglitazone plus metformin was well tolerated. Copyright © 2002 John Wiley & Sons, Ltd.