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Effect of metformin in pediatric patients with type 2 diabetes: a randomized controlled trial
Kenneth Lee Jones1, Silva Arslanian, Valentina A Peterokova
1University of California, San Diego Medical Center, San Diego, California 92093, USA. kljones@ucsd.edu
Insights
Metformin effectively and safely treats type 2 diabetes in children. This study showed significant improvements in glycemic control for pediatric patients, with similar adverse events to adults.
Area of Science:
- Pediatric Endocrinology
- Metabolic Disorders
- Clinical Pharmacology
Background:
- Type 2 diabetes incidence in children has risen dramatically.
- Metformin is a common oral antidiabetic agent for adults but lacks formal study in pediatric populations.
- Addressing the unmet need for pediatric type 2 diabetes treatment is critical.
Purpose of the Study:
- To evaluate the safety and efficacy of metformin in pediatric patients with type 2 diabetes.
- To establish appropriate dosing and assess treatment outcomes in children aged 10-16 years.
- To compare metformin's effects against a placebo in a controlled trial.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 82 pediatric subjects (10-16 years).
- Dosing up to 1,000 mg of metformin twice daily for up to 16 weeks.
- Inclusion criteria included specific fasting plasma glucose (FPG) and HbA1c levels, stimulated C-peptide, and BMI percentile.
Main Results:
- Metformin significantly improved glycemic control, with a mean FPG change of -2.4 mmol/l versus +1.2 mmol/l for placebo (P < 0.001).
- Mean HbA1c levels were significantly lower in the metformin group (7.5%) compared to placebo (8.6%) (P < 0.001).
- No negative impact on body weight or lipid profile was observed; adverse events were comparable to adult metformin use.
Conclusions:
- Metformin is a safe and effective treatment option for type 2 diabetes in pediatric patients.
- The study supports the use of metformin for glycemic control in children with type 2 diabetes.
- Further research may explore long-term outcomes and optimal management strategies.
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 > or =7.0 and < or =13.3 mmol/l (> or =126 and < or =240 mg/dl), HbA(1c) > or =7.0%, stimulated C-peptide > or =0.5 nmol/l (> or =1.5 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.