METFORMIN HYDROCHLORIDE for Type 1 diabetes | Vascular calcification

Inclusion criteria

• {"criterion_text":"- Type 1 diabetes"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- For women in childbearing age, effective contraception during the whole trial"}
• {"criterion_text":"- Signed written informed consent"}
• {"criterion_text":"- Affiliation of a social security regime (patient with AME cannot be included)"}

Exclusion criteria

• {"criterion_text":"- Creatinine clearance of less than 3 months <60 mL/mn (MDRD) at the inclusion time"}
• {"criterion_text":"- Patient under legal protection measure (tutorship or curatorship) or deprived of freedom or under measure of safety"}
• {"criterion_text":"- Unable to consent"}
• {"criterion_text":"- Known metformin contra-indication: •\tsevere liver insufficiency –CHILD B or C •\theart failure (FEVG<45%) or •\thistory of pulmonary oedema, respiratory insufficiency with history of acute respiratory failure or patients receiving oxygen therapy •\tchronic ethylism •\tlactic acidosis"}
• {"criterion_text":"- Known hypersensitivity to metformin or to any of its excipients or placebo excipients (lactose)"}
• {"criterion_text":"- Indication or history of lower limb angioplasty (with stenting) and/or bypass"}
• {"criterion_text":"- Previous treatment with metformin (within 3 months prior to inclusion)"}
• {"criterion_text":"- HbA1c of less than 3 months >11%"}
• {"criterion_text":"- Chronic inflammatory disease or chronic immune-suppressive drugs intake"}
• {"criterion_text":"- Participation in an another interventional trial (Jardé 1 and 2) or in the exclusion period of any other interventional study"}
• {"criterion_text":"- Pregnancy woman (confirmed by a sanguine beta-HCG test) or breastfeeding woman"}

Primary endpoints

• {"endpoint_text":"- Difference between below-knee arterial calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin.","definition_or_measurement_approach":"Calcification score evaluated by CT-scan at baseline (T0) and at 2 years (T2years); primary outcome is the difference between scores at T0 and T2years."}

Secondary endpoints

• {"endpoint_text":"- Difference between below-knee arterial ultrasonographic occlusion score at T0 and T2years in type 1 diabetic patients supplemented or not with metformin.","definition_or_measurement_approach":"Ultrasonographic arterial occlusion score measured at baseline (T0) and at 2 years (T2years); endpoint is difference between timepoints."}
• {"endpoint_text":"- Difference between ankle and toe brachial indexes at T0 and T2years in type 1 diabetic patients supplemented or not with metformin.","definition_or_measurement_approach":"Ankle and toe brachial indexes measured at baseline (T0) and at 2 years (T2years); endpoint is difference between timepoints."}
• {"endpoint_text":"- Difference between pulse wave velocity at T0 and T2 years in type 1 diabetic patients supplemented or not with metformin.","definition_or_measurement_approach":"Pulse wave velocity measured at baseline (T0) and at 2 years (T2years); endpoint is difference between timepoints."}
• {"endpoint_text":"- Difference between coronary calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin.","definition_or_measurement_approach":"Coronary calcification score evaluated by CT-scan at baseline (T0) and at 2 years (T2years); endpoint is difference between timepoints."}
• {"endpoint_text":"- Difference between below-knee arterial calcification score progression between T0 and T2years in type 1 diabetic patients treated or not with metformin and with initial below-knee arterial calcification score ≤ and >400.","definition_or_measurement_approach":"Progression of below-knee arterial calcification score between baseline (T0) and 2 years (T2years), with subgroup analysis by initial score (≤400 vs >400)."}

France

Earliest CTIS Part Ii Submission Date

11-06-2024

Latest Decision Or Authorization Date

10-09-2024

Processing Time Days

91

Number Of Sites

1

Number Of Participants

230

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Organisation name Direction Générale de l’Offre des Soins du Ministère de la santé et de la prévent","duties_or_roles":"Monetary support","organisation_type":""}