Could a common diabetes drug protect arteries in type 1 diabetes?
NCT ID NCT04583462
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether metformin, a drug used for type 2 diabetes, can slow the buildup of calcium in leg arteries of people with type 1 diabetes. 230 adults will take either metformin or a placebo for two years. The goal is to see if metformin reduces artery hardening, which can lead to heart problems and amputations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin
- What this could lead to
- If it works, this could point toward a way to reduce dangerous artery hardening in people with type 1 diabetes, potentially lowering heart and limb risks.
- What could go wrong
- This is a phase 3 trial, but metformin is already widely used for type 2 diabetes. It may not work for this specific complication, and side effects like stomach upset are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 230 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2021
- Expected to finish
-
Oct 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Pitié Salpêtrière Hospital, AP-HP, Diabetology department
Paris, 75013, France
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