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Could a common diabetes drug ease muscle problems in Steinert's disease?

NCT ID NCT05532813

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This phase 3 trial is testing whether metformin, a common diabetes drug, can improve muscle function in adults with myotonic dystrophy type 1 (Steinert's disease). The study will enroll 142 participants who will receive either metformin or a placebo for 6 months. Researchers will measure changes in motor function, strength, and quality of life.

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 treatment to improve muscle function and quality of life in people with myotonic dystrophy type 1.
What could go wrong
This is a phase 3 trial, but metformin is already used for diabetes; its benefit for muscle function in this disease is unproven. Side effects like digestive issues or rare lactic acidosis 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 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2026

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 70 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: * DM1 disease confirmed by genetic analysis * Men and women between 18 and 70 years of age. * Preserved walking abilities (stick assistance possible) * MIRS score 3 or 4 * Women of childbearing potential under efficient contraception during treatment * Patient able to consent * All patients who have completed and signed the specific information and informed consent form * Affiliation to a social security system Exclusion Criteria: * Pregnant or breast-feeding women * Men with an intention to conceive a child during the time of the study * Contraindications to Metformin (hypersensitivity to metformin or to one of the excipients) * Respiratory: * Patient requiring tracheotomy or * Patient requiring non-invasive-ventilation: - more than 12 hours per day; - insufficiently ventilated * Creatinine clearance inferior to 50 ml/min * Cardiac: * Left ventricular ejection fraction below 35% * Conduction system disease on the electrocardiogram with PR interval \>200 ms or QRS duration \>110 ms without a pacemaker or an implantable defibrillator or cardiac electrophysiological study performed over the past 5 years * Third-degree or Second degree type II atrioventricular block without a pacemaker or an implantable defibrillator * Sustained ventricular tachycardia * Acute disease that may lead to tissue hypoxia

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Conditions

The condition(s) this trial relates to.

myotonic dystrophy myotonic dystrophy type 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metformin Myotonic dystrophy 1 Steinert's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Neurology Department, Raymond-Poincaré hospital - APHP

    RECRUITING

    Garches, 92380, France

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