NCT04583462 (IMPACT-1D) is a Phase 3 clinical trial of Metformin in Type 1 Diabetes, sponsored by Assistance Publique - Hôpitaux de Paris.

Who is sponsoring NCT04583462?

NCT04583462 is sponsored by Assistance Publique - Hôpitaux de Paris.

What drugs are being tested in NCT04583462?

Interventions in NCT04583462: Metformin, Placebo.

What condition does NCT04583462 study?

NCT04583462 studies Type 1 Diabetes, Peripheral Arterial Calcification.

Is NCT04583462 still recruiting?

NCT04583462 is currently active, enrolled. Last updated 24 November 2025.

Last reviewed 2025-11-24 · How we verify

NCT04583462: IMPACT-1D

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes

Active, enrolled Phase 3 Last updated 24 November 2025

What this trial tests

Phase 3 trial testing Metformin in Type 1 Diabetes in 230 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

2 June 2021

Primary endpoint
29 September 2027

29 October 2027

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	230
Start date	2 June 2021
Primary completion	29 September 2027
Estimated completion	29 October 2027
Sites	1 location across France

Drugs / interventions tested

Metformin (metformin) — full drug profile →
Placebo

Conditions studied

Type 1 Diabetes — all drugs for Type 1 Diabetes →
Peripheral Arterial Calcification — all drugs for Peripheral Arterial Calcification →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 80, any sex, with Type 1 Diabetes or Peripheral Arterial Calcification. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Connecting epigenetics and inflammation in vascular senescence: state of the art, biomarkers and senotherapeutics.
Fraile-Martinez O, De Leon-Oliva D, Boaru DL, De Castro-Martinez P, et al · · 2024 · cited 8× · PMID 38469117 · DOI 10.3389/fgene.2024.1345459
Advancing Type 1 Diabetes Management: Integrating Novel Therapies, Technologies, and Adjunctive Approaches.
Snaith JR, Narongkiatikhun P, Bjornstad P, Greenfield JR, et al · · 2026 · PMID 40880508 · DOI 10.2337/dci25-0015

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

NCT07061574 — A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New On · Phase 1, PHASE2 · recruiting
NCT07360080 — Long-Term Outcomes of Teplizumab in Routine Clinical Care · recruiting
NCT07457580 — Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · recruiting
NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04583462 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
Last refreshed: 24 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04583462.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing