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Evaluation of the Safety and Efficacy of Metformin in Steinert's Disease: A Prospective, Multicenter, Randomized, Double Blind, Phase 3 Trial
EU CTIS ID: 2023-507660-39-00
What this study is testing
To evaluate the efficacy of metformin vs placebo, on the improvement of muscle function in DM1 patients.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- DM1 disease confirmed by genetic analysis
- Men and women between 18 and 70 years of age
- Preserved walking abilities (stick assistance possible)
- MIRS (Muscular Impairment Rating Scale) 3 or 4
- Women of childbearing potential under efficient contraception during treatment and up to 2 days after the end of the experimental treatment
- Ability to provide signed informed consent
You likely can't join if
- Diabetic patient
- Patient already taking metformin
- Pregnant or breast-feeding women
- Men with an intention to conceive a child during the time of the study
- Contraindications to Metformin: o All types of acute metabolic acidosis o Acute conditions that may impair renal function, such as: dehydration, severe infection, shock o Hepatocellular insufficiency, acute alcohol intoxication, alcoholism o Hypersensitivity to metformin or to one of the excipients o Acute disease that may lead to tissue hypoxia such as decompensated heart failure, acute respiratory failure, recent myocardial infarction. - Respiratory contraindications: o Patient requiring tracheotomy or o Patient requiring non-invasive-ventilation: - more than 12 hours per day - insufficiently ventilated
- Creatinine clearance inferior to 60 ml/min (MDRD).
See the full eligibility criteria
- DM1 disease confirmed by genetic analysis
- Men and women between 18 and 70 years of age
- Preserved walking abilities (stick assistance possible)
- MIRS (Muscular Impairment Rating Scale) 3 or 4
- Women of childbearing potential under efficient contraception during treatment and up to 2 days after the end of the experimental treatment
- Ability to provide signed informed consent
- Capacity of the patient to understand French language or presence of a relative (or the medical team) who can help the patient understand the study.
- Affiliation to a social security system
- Diabetic patient
- Patient already taking metformin
- Pregnant or breast-feeding women
- Men with an intention to conceive a child during the time of the study
- Contraindications to Metformin: o All types of acute metabolic acidosis o Acute conditions that may impair renal function, such as: dehydration, severe infection, shock o Hepatocellular insufficiency, acute alcohol intoxication, alcoholism o Hypersensitivity to metformin or to one of the excipients o Acute disease that may lead to tissue hypoxia such as decompensated heart failure, acute respiratory failure, recent myocardial infarction. - Respiratory contraindications: o Patient requiring tracheotomy or o Patient requiring non-invasive-ventilation: - more than 12 hours per day - insufficiently ventilated
- Creatinine clearance inferior to 60 ml/min (MDRD).
- Cardiac contraindications: o Left ventricular ejection fraction below 35% o 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 has been performed o Third-degree or Second degree type II atrioventricular block without a pacemaker or an implantable defibrillator o Sustained ventricular tachycardia o Acute cardiac failure o Myocardial infarction of less than three months
- Patient participating in another interventional clinical trial
- Patient under legal protection (curatorship, tutorship)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.