Effect of metformin in pediatric patients with type 2 diabetes - A randomized controlled trial

OBJECTIVE- Metformin is the most commonly prescribed oral antidiabetic agent in the U.S. for adults with type 2 diabetes. The incidence of type 2 diabetes in children has increased dramatically over the past 10 years, and yet, metformin has never been formally studied in children with type 2 diabetes. RESEARCH DESIGN AND METHODS- This study evaluated the safety and efficacy of metformin at doses up to 1,000 mg twice daily in 82 subjects aged 10-16 years for up to 16 weeks in a randomized double-blind placebo-controlled trial from September 1998 to November 1999. Subjects with type 2 diabetes were enrolled if they had a fasting plasma glucose (FPG) levels greater than or equal to7.0 and less than or equal to 13.3 mmol/l (greater than or equal to 126 and less than or equal to 240 mg/dl), HbA(1c) greater than or equal to7.0%, stimulated C-peptide greater than or equal to0.5 nmol/l (greater than or equal to1.5 ng/ml), and a BMI > 50th percentile for age. RESULTS- Metformin significantly improved glycemic control. At the last double-blind visit, the adjusted mean change from baseline in FPG was -2.4 mmol/l (-42.9 mg/dl) for metformin compared with +1.2 mmol/l (+21.4 mg/dl) for placebo (P < 0.001). Mean HbA(1c) values, adjusted for baseline levels, were also significantly lower for metformin compared with placebo (7.5 vs. 8.6%, respectively; P < 0.001). Improvement in FPG was seen in both sexes and in all race subgroups. Metformin did not have a negative impact on body weight or lipid profile. Adverse events were similar to those reported in adults treated with metformin. CONCLUSION- Metformin was shown to be safe and effective for treatment of type 2 diabetes in pediatric patients.