CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Metformin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01813929
NCT01813929Phase 4Completed

Effect of Metformin on Vascular and Mitochondrial Function in Type 1 Diabetes

University of Colorado, Denver·interventional·Posted Mar 19, 2013·Updated Jan 21, 2022

In Brief

A Phase 4 clinical trial evaluating Metformin and Placebo for Type 1 Diabetes. Completed, enrolled 23 participants across 1 site.

Detailed Summary

Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk in type 1 diabetes (T1D). The purpose of this study is to measure the effect of metformin on insulin sensitivity, vascular function and compliance, and mitochondrial function in T1D. The long term goal is to identify novel non-glycemic approaches to managing cardiovascular disease risk in T1D. The results of this study may validate a novel approach to T1D treatment that could significantly improve current management of cardiovascular disease risk in this high risk population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 19, 2013
Enrollment StartJun 1, 2011
Primary CompletionMar 24, 2017
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 13.3 years ago

Interventions

Metformindrug

Six week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, 500/1000 for one week, and then 1000mg twice daily for the remainder of the 6 week intervention. If uptitration is not tolerated, max dose will be max tolerated dose of at least 500 mg twice daily.

Placebodrug

Six-week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, and then the higher dose (850 mg) for the remainder of the 6 week intervention.