NCT01881828

Metformin Therapy for Overweight Adolescents With Type 1 Diabetes

A Randomized Trial of Metformin as Adjunct Therapy for Overweight Adolescents With Type 1 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 12 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Metformin (glucophage)	The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
OTHER	oral placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2013-06-20
• Last updated: 2020-03-03
• Results posted: 2018-12-19

Locations

1 site across 1 country: United States