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Clinical Trial Details

Trial ID: L2314
Source ID: NCT01334125
Associated Drug: Metformin
Title: Adjunctive Metformin Therapy in Double Diabetes
Acronym: AMTIDD
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01334125/results
Conditions: Diabetes Mellitus
Interventions: DRUG: Metformin|DRUG: Placebo
Outcome Measures: Primary: Baseline Adjusted Hemoglobin A1c Over Time, 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)., Baseline, 3mo, 6mo, and 9 months | Secondary: Baseline Adjusted Changes in Lipid Profile Over Time, 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, 3mo, 6mo, and 9 months|Baseline Adjusted Changes in Adiponectin/Leptin Ratio Over Time, 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)., Baseline, 3mo, 6 mo, and 9 months|Number of Participants With Minor, Major, and Nocturnal Hypoglycemia, 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)., 12 months
Sponsor/Collaborators: Sponsor: University of Massachusetts, Worcester
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE3
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2011-02
Completion Date: 2014-12
Results First Posted: 2016-03-04
Last Update Posted: 2016-03-04
Locations: UmassMemorial Medical Center, Worcester, Massachusetts, 01655, United States
URL: https://clinicaltrials.gov/show/NCT01334125