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Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes
EU CTIS ID: 2024-511867-27-00
What this study is testing
To show that metformin, patients with type 1 diabetes but without chronic kidney disease, is able to slow below- knee arterial calcification
- 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
- 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 (patient with AME cannot be included)
You likely can't join if
- Creatinine clearance of less than 3 months <60 mL/mn (MDRD) at the inclusion time
- Patient under legal protection measure (tutorship or curatorship) or deprived of freedom or under measure of safety
- Unable to consent
- Known metformin contra-indication: • severe liver insufficiency –CHILD B or C • heart failure (FEVG<45%) or • history of pulmonary oedema, respiratory insufficiency with history of acute respiratory failure or patients receiving oxygen therapy • chronic ethylism • lactic acidosis
- Known hypersensitivity to metformin or to any of its excipients or placebo excipients (lactose)
- Indication or history of lower limb angioplasty (with stenting) and/or bypass
See the full eligibility criteria
- 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 (patient with AME cannot be included)
- Creatinine clearance of less than 3 months <60 mL/mn (MDRD) at the inclusion time
- Patient under legal protection measure (tutorship or curatorship) or deprived of freedom or under measure of safety
- Unable to consent
- Known metformin contra-indication: • severe liver insufficiency –CHILD B or C • heart failure (FEVG<45%) or • history of pulmonary oedema, respiratory insufficiency with history of acute respiratory failure or patients receiving oxygen therapy • chronic ethylism • lactic acidosis
- Known hypersensitivity to metformin or to any of its excipients or placebo excipients (lactose)
- Indication or history of lower limb angioplasty (with stenting) and/or bypass
- Previous treatment with metformin (within 3 months prior to inclusion)
- HbA1c of less than 3 months >11%
- Chronic inflammatory disease or chronic immune-suppressive drugs intake
- 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-HCG test) or breastfeeding woman
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.