Metformin Therapy for Overweight Adolescents With Type 1 Diabetes

Summary

The objective of the proposed research is to evaluate the efficacy and safety of the use of metformin in addition to standard insulin therapy in overweight and obese children and adolescents, age 12-\<20 years, with type 1 diabetes for at least 1 year. Secondary objectives are to assess the effect of metformin on C-peptide levels, a measure of how much insulin is still being produced by the beta cells of the pancreas, and on vascular dysfunction. In addition, an ancillary study is planned to assess if metformin will improve tissue-specific insulin resistance in type 1 diabetes using a hyperinsulinemic euglycemic clamp.

Timeline

Start

2013-09

Primary completion

2014-09

Completion

2014-12

Outcome

Missed primary endpoint

paper However, this differential effect was not sustained at 26-week follow up when mean change in HbA1c from baseline was 0.2% in each group PMID 26624824 ↗

paper the addition of metformin to insulin did not improve glycemic control after 6 months. PMID 26624824 ↗

Publications

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• Background Urbina EM, Wadwa RP, Davis C, Snively BM, Dolan LM, Daniels SR, Hamman RF, Dabelea D. Prevalence of increased arterial stiffness in children with type 1 diabetes mellitus differs by measurement site and sex: the SEARCH for Diabetes in Youth Study. J Pediatr. 2010 May;156(5):731-7, 737.e1. doi: 10.1016/j.jpeds.2009.11.011. Epub 2010 Jan 25.
• Background Wadwa RP, Urbina EM, Anderson AM, Hamman RF, Dolan LM, Rodriguez BL, Daniels SR, Dabelea D; SEARCH Study Group. Measures of arterial stiffness in youth with type 1 and type 2 diabetes: the SEARCH for diabetes in youth study. Diabetes Care. 2010 Apr;33(4):881-6. doi: 10.2337/dc09-0747. Epub 2010 Jan 12.
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• Libman IM, Miller KM, DiMeglio LA, Bethin KE, Katz ML, Shah A, Simmons JH, Haller MJ, Raman S, Tamborlane WV, Coffey JK, Saenz AM, Beck RW, Nadeau KJ; T1D Exchange Clinic Network Metformin RCT Study Group. Effect of Metformin Added to Insulin on Glycemic Control Among Overweight/Obese Adolescents With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2015 Dec 1;314(21):2241-50. doi: 10.1001/jama.2015.16174.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	2000 mg	Oral

Indications