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Could a common diabetes drug protect arteries in type 1 diabetes?

NCT ID NCT04583462

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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