At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 493 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Not stated in 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.
Phase 3 Study of Metformin in Adults With Type 1 Diabetes
In Brief
A Phase 3 clinical trial evaluating Metformin and Placebo for Diabetes Mellitus, Type 1. Completed, enrolled 493 participants across 24 sites in 5 countries.
Detailed Summary
The trial is conducted in the United Kingdom (UK), Australia, Canada, Denmark and the Netherlands. The aim is to test whether 3 years treatment with metformin added to titrated insulin therapy (towards target HbA1c 7.0%/53 mmol/mol) reduces atherosclerosis, as measured by progression of carotid intima-media thickness (cIMT), in adults with confirmed type 1 diabetes aged 40 years and over at increased risk for cardiovascular disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesAustralia, Canada, Denmark, Netherlands, United Kingdom
CollaboratorsNHS Greater Glasgow and Clyde, Juvenile Diabetes Research Foundation, Imperial College London, University of Wisconsin, Madison, University of Dundee, Merck Serono S.A., Geneva, Itamar-Medical, Israel, University of Western Ontario, Canada, University of Melbourne, Steno Diabetes Center Copenhagen, Maastricht University Medical Center
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartDec 2011
Primary CompletionMar 2017
Study CompletionApr 2017
TodayJul 2026
First PostedDec 1, 2011
Enrollment StartDec 1, 2011
Primary CompletionMar 19, 2017
Study CompletionApr 18, 2017
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 14.6 years ago
Interventions
Metformindrug
3 years treatment duration
Placebodrug
3 years duration