title: Effect of metformin in pediatric patients with type 2 diabetes: a randomized controlled trial.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  Metformin was shown to be safe and effective for treatment of type 2 diabetes in pediatric patients.
authors.affiliation: University of California, San Diego Medical Center, San Diego, California 92093, USA. kljones@ucsd.edu
authors.forename: Kenneth Lee
authors.initials: KL
authors.lastname: Jones
authors.forename: Silva
authors.initials: S
authors.lastname: Arslanian
authors.forename: Valentina A
authors.initials: VA
authors.lastname: Peterokova
authors.forename: Jong-Soon
authors.initials: JS
authors.lastname: Park
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Tomlinson
mesh_terms: D000293:Adolescent; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D002096:C-Peptide / Q000032:analysis; D002648:Child; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008687:Metformin / Q000627:therapeutic use*; D010919:Placebos; D044469:Racial Groups
chemical_list: D001786:Blood Glucose; D002096:C-Peptide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010919:Placebos