Clinical Trial: Adjunctive Metformin Therapy in Double Diabetes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: University of Massachusetts, Worcester

Current Primary Outcome: Baseline Adjusted Hemoglobin A1c Over Time [ Time Frame: Baseline, 3mo, 6mo, and 9 months ]

Comparison of the baseline-adjusted differences in HbA1c between the metformin and placebo groups during the trial. Hemoglobin A1c is a marker of glycemic control. The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).


Original Primary Outcome: The proportion of subjects reaching HbA1c levels <8% at 12 months. [ Time Frame: Every 3 months for 12 months ]

Current Secondary Outcome:

  • Baseline Adjusted Changes in Lipid Profile Over Time [ Time Frame: Baseline, 3mo, 6mo, and 9 months ]
    Comparison of the baseline-adjusted differences in total cholesterol/high density cholesterol index over time between the metformin and the placebo groups. The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).
  • Baseline Adjusted Changes in Adiponectin/Leptin Ratio Over Time [ Time Frame: Baseline, 3mo, 6 mo, and 9 months ]
    Comparison of the baseline-adjusted differences in adiponectin/leptin ratio over time between the metformin and the placebo groups. The reported values represented mean adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).
  • Number of Participants With Minor, Major, and Nocturnal Hypoglycemia [ Time Frame: 12 months ]
    Comparison of the occurrence of hypoglycemic event requiring a third party assistance (major hypoglycemia) per subject during the study, and minor hypoglycemia (plasma glucose of <60 mg/dL or no measurement), as well as nocturnal hypoglycemia (plasma glucose of ≤60 mg/dL between 11PM and 6AM).


Original Secondary Outcome:

  • Changes in anthropometry [ Time Frame: Every 3 months for 12 months ]
  • Changes in lipid profile [ Time Frame: Every 3 months for 12 months ]
  • Changes in adipocytokines [ Time Frame: Every 3 months for 12 months ]
  • Changes in total daily insulin requirement [ Time Frame: Every 3 months for 12 months ]
  • Assessment of the rates of hypoglycemia (blood glucose level ≤60 mg/dL) or hypoglycemic event requiring a third party assistance per subject per week. [ Time Frame: Every week for 12 months ]


Information By: University of Massachusetts, Worcester

Dates:
Date Received: March 21, 2011
Date Started: February 2011
Date Completion:
Last Updated: March 3, 2016
Last Verified: March 2016