NCT01334125

Adjunctive Metformin Therapy in Double Diabetes

Glycemic Control in Children and Adolescents With Double Diabetes: Trial of Optimized Insulin-Metformin Regimen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 10 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

The significance of this project is to investigate the effects of adjunctive metformin therapy in children and adolescents with double diabetes. Double diabetes describes a clinical state where an individual possesses features of both type 1 and type 2 diabetes. There is a paucity of data on the role of adjunctive metformin therapy in children and adolescents with double diabetes. To help fill this knowledge gap, the investigators propose a randomized, double-blind, placebo-controlled trial of metformin in double diabetes. Specifically, the investigators will evaluate changes in hemoglobin A1c and anthropometry in patients with a diagnosis of type 1 diabetes who also have features of type 2 diabetes or metabolic syndrome as well as patients with type 2 diabetes who possess diabetes-associated autoantibodies. This will help determine the safety profile, and efficacy of adjunctive metformin therapy in these subjects.

Detailed description

In this 12-month clinical trial, a 3-month run-in period will precede the interventional phase of the study. All patients will be placed on treat-to-target insulin regimen alone during the run-in phase. At the end of the 3-month run-in period, all participants will continue on treat-to-target insulin regimen, and will then be randomized to either of the 2 arms of the study: an experimental arm, consisting of treat-to-target insulin regimen plus metformin, and a control arm consisting of treat-to-target insulin regimen plus placebo. Both the physicians and patients will be blinded to the oral agents being administered to patients.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Metformin	Metformin 1000 mg once daily by mouth for 9 months
DRUG	Placebo	2 capsules once daily by mouth for 9 months

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-04-12
• Last updated: 2016-03-04
• Results posted: 2016-03-04

Locations

1 site across 1 country: United States