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ARS Home » Plains Area » Houston, Texas » Children's Nutrition Research Center » Research » Publications at this Location » Publication #330084

Title: Effect of metformin added to insulin on glycemic control among overweight/obese adolescents with type 1 diabetes: A randomized clinical trial

Author
item LIBMAN, INGRID - University Of Pittsburgh Medical Center
item MILLER, KELLEE - Jaeb Center For Health Research
item DIMEGLIO, LINDA - Indiana University School Of Medicine
item BETHIN, KATHLEEN - University Of Buffalo
item KATZ, MICHELLE - Joslin Diabetes Center
item BACHA, FIDA - Children'S Nutrition Research Center (CNRC)

Submitted to: Journal of the American Medical Association
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 11/1/2015
Publication Date: 12/1/2015
Citation: Libman, I.M., Miller, K.M., Dimeglio, L.A., Bethin, K.E., Katz, M.L., Bacha, F. 2015. Effect of metformin added to insulin on glycemic control among overweight/obese adolescents with type 1 diabetes: A randomized clinical trial. Journal of the American Medical Association. 314(21):2241-2250.

Interpretive Summary: Insulin is the main treatment for youth with type 1 diabetes (T1D). Overweight children with T1D have evidence of insulin resistance. Whether the addition of metformin (insulin sensitizer) to the treatment regimen in overweight children with T1D will help improve diabetes control is unclear. This multicenter study randomized 140 children and adolescents with T1D to metformin or placebo in addition to insulin, for 26 weeks. We did not find significant differences in glycemic control (reduction in HbA1c) between the 2 groups. However, the group that received metformin had a reduction in the total daily insulin dose and greater improvement in body mass index, compared with the placebo group. In conclusion, in overweight adolescents with T1D, the addition of metformin to insulin did not improve glycemic control after 6 months. These results do not support providing metformin to overweight adolescents with type 1 diabetes to improve glycemic control.

Technical Abstract: Previous studies assessing the effect of metformin on glycemic control in adolescents with type 1 diabetes have produced inconclusive results. To assess the efficacy and safety of metformin as an adjunct to insulin in treating overweight adolescents with type 1 diabetes. Multicenter (26 pediatric endocrinology clinics), double-blind, placebo-controlled randomized clinical trial involving 140 adolescents aged 12.1 to 19.6 years (mean [SD] 15.3 [1.7] years) with mean type 1 diabetes duration 7.0 (3.3) years, mean body mass index (BMI) 94th (4) percentile, mean total daily insulin 1.1 (0.2) U/kg, and mean HbA1c 8.8% (0.7%). Randomization to receive metformin (n'='71) (