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Clinical Trials in France / NCT04583462
Active, not recruiting Phase 3

Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes

NCT04583462 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Phase 3
Started
2021-06-02
Last updated
2025-11-24

Condition(s) studied

Type 1 DiabetesPeripheral Arterial Calcification

Investigational drug(s) / intervention(s)

Metformin →Placebo

Metformin: Metformin, started at 500 mg per day per os and titrated up to 2000 mg during 2 years (increase of 500 mg every two weeks)

Placebo: Control group : Placebo (coated tablet similar to metformin tablet titrated following the same schedule as in the experimental arm) started at 500 mg per day per os and titrated up to 2000 mg during 2 years (increase of 500 mg every two weeks)

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Type 1 diabetes 2. Women and Men ≥ 18 years old and ≤ 80 years old with: * Complications: diabetic retinopathy and/or nephropathy (with creatinine clearance ≥ 60 mL/mn) and/or neuropathy and/or peripheral arterial occlusive disease and/or cardiopathy and/or stroke and/or * cardiovascular risk factors : hypertension and/or dyslipidemia (HDL \< 0.35g/L or LDL \> 1.9g/L or treated dyslipidemia) and/or tobacco use (old or active smoking greater than 5 pack years) and/or * Diabetes duration \>20 years 3. For women in childbearing age, effective contraception during the whole trial 4. Signed written informed consent 5. Affiliation of a social security regime (AME excluded) Exclusion Criteria: 1. Creatinine clearance of less than 3 months \<60 mL/mn (MDRD) at the inclusion time 2. Known metformin contra-indication: severe liver insufficiency -CHILD B or C, heart failure (FEVG\<45%) or history of pulmonary edema, respiratory insufficiency with history of acute respiratory failure or patients receiving oxygen therapy, chronic ethylism, lactic acidosis 3. Know sensitivity to metformin or to any of its excipients or placebo excipients (lactose) 4. Indication or history of lower limb angioplasty (with stenting) and/or bypass 5. Previous treatment with metformin (within 3 months prior to inclusion) 6. HbA1c of less than 3 months \>11% 7. Chronic inflammatory disease or chronic immune-suppressive drugs intake 8. Participation in an another interventional trial (Jardé 1 and 2) or in the exclusion period of any other interventional study 9. Pregnancy woman (confirmed by a sanguine beta-human chorionic gonadotropin test) or breastfeeding woman 10. Patient under legal protection measure (tutorship or curatorship) or deprived of freedom 11. Unable to consent

Primary outcome measure(s)

  • Change between below-knee arterial calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin. — Change between T0 baseline visit and T2 years
    Below-knee artery calcification scores will be obtained after scanning with a 128-slice multidetector CT scanner without contrast, in a craniocaudal direction, from the bottom of the patella down to the ankle region. The 3-mm cross-sectional slices were separately analyzed. Analysis was performed by radiologists kept blind about the results of the color duplex ultrasonography, laboratory tests, and clinical examinations, using a commercially available software package (Heartbeat CaScore; Philips Healthcare). On cross-sectional images, areas of calcification along below-knee arteries with a density ≥130 Hounsfield units attenuation and a surface \>1 mm2 were identified automatically. Calcification score, determined according to the method described by Agatston et al, will be obtained separately for each of the main below-knee arteries (distal popliteal, anterior tibial, posterior tibial, and peroneal arteries) and added up to obtain the calc

Trial sites (1)

FacilityCityRegionStatus
Pitié Salpêtrière Hospital, AP-HP, Diabetology department Paris France

On this site

📄 Glucophage (metformin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04583462 on ClinicalTrials.gov ↗ ← All trials in France