NEW YORK (Reuters Health) – The oral antidiabetic agent metformin is as effective and well tolerated in children as it is in adults, according to a report in the January issue of Diabetes Care.
Dr. Kenneth Lee Jones, of the University of California, San Diego, and colleagues point out that type 2 diabetes prevalence has increased markedly in children but metformin has not been tested in this population. They therefore examined its safety and efficacy at doses up to 1000 mg twice daily in a randomized, double-blind, placebo-controlled trial involving 82 type 2 diabetic children (ages 10 to 16 years) for up to 16 weeks.
At baseline, the children had a fasting plasma glucose (FPG) between 7.0 mmol/L and 13.3 mmol/L (between 126 mg/dL and 240 mg/dL), HbA1c at least 7.0%, stimulated C-peptide at least 0.5 nmol/L (at least 1.5 ng/mL), and a body mass index above the 50th percentile for age.
Forty-two subjects were randomized to receive metformin, and 40 were randomized to receive placebo. Six patients (14.3%) from the metformin group discontinued therapy before 16 weeks, compared with four patients (10.0%) from the placebo group.
Glycemic control was significantly improved by metformin, according to the report. At the last visit, metformin patients had a mean change in FPG of -2.4 mmol/L (-42.9 mg/dL), compared with +1.2 mmol/L (+21.4 mg/dL) for placebo patients (p < 0.001). Patients in the metformin group also had significantly lower HbA1c levels at followup compared with patients in the placebo group (7.5% versus 8.6%, p < 0.001).
"Improvement in FPG was seen in both sexes and in all race subgroups," Dr. Jones and colleagues report. "Metformin did not have a negative impact on body weight or lipid profile." Adverse events included abdominal pain, diarrhea, nausea/vomiting, and headache.