NCT04583462Active, not recruitingPhase 3
Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes
Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes: a Double Blind Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- First submitted
- 5 Oct 2020
- Start date
- 2 Jun 2021
- Primary completion date
- 29 Sept 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Type 1 diabetes
- NCT number
- NCT04583462
- EU CT number
- 2024-511867-27-00
- EudraCT number
- 2018-003121-29
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 230
- From 2 Jun 2021 to the primary completion date, 29 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Previous treatment with metformin (within 3 months prior to inclusion)
Other illness
- Indication or history of lower limb angioplasty (with stenting) and/or bypass
- Chronic inflammatory disease or chronic immune-suppressive drugs intake
Lab values
- Creatinine clearance of less than 3 months \<60 mL/mn (MDRD) at the inclusion time
- HbA1c of less than 3 months \>11%
Other
- Know sensitivity to metformin or to any of its excipients or placebo excipients (lactose)
- Participation in an another interventional trial (Jardé 1 and 2) or in the exclusion period of any other interventional study
- Pregnancy woman (confirmed by a sanguine beta-human chorionic gonadotropin test) or breastfeeding woman
- Patient under legal protection measure (tutorship or curatorship) or deprived of freedom
- Unable to consent
Who the study is looking for
- Type 1 diabetes
- 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
- For women in childbearing age, effective contraception during the whole trial
- Signed written informed consent
- Affiliation of a social security regime (AME excluded)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.