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NCT04583462 · ClinicalTrials.gov record · last posted 2025-11-24

Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes

Study acronym: IMPACT-1D
StatusActive, Not Recruiting
PhasePhase 3
Started2021-06-02
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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

Amendment record 2 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 2 times since 2020-10-05; most recent amendment 2025-11-20. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-11-20
Status change Recruiting→Active, Not Recruitingv2
2021-10-28
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT04583462
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Type 1 Diabetes, Peripheral Arterial Calcification
Enrollment 230 participants
Start Date 2021-06-02
Primary Completion 2027-09-29 (estimated)
Study Completion 2027-10-29 (estimated)
Updated on ClinicalTrials.gov 2025-11-24