drugset / Trial / NCT04583462

Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes

NCT04583462 ↗

Phase 3 Active not recruiting 230 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Vascular calcification (VC) is a complication frequently observed in elderly, in chronic kidney disease (CKD) and in diabetes (particularly in type 1 diabetes). VC is a dynamic pathophysiological process that causes cardiovascular morbidity and is an independent risk factor of major amputation. In vitro and human observational studies have suggested a role of metformin in preventing VC. The investigators propose to test the effect of metformin treatment during two years on lower limb arterial calcification evaluated by CT-scan in patients with type 1 diabetes and without CKD. This research is a phase III double blind randomized controlled trial consisting of 2 years double-blind treatment phase (patients randomized to metformin or placebo) in type 1 diabetic patients. The participants and the investigators will be blinded to the study medications taken during the double-blind treatment period

Timeline

Start
2021-06-02
Primary completion
2027-09-29
Completion
2027-10-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 2000 mg Oral