Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes

Korábbi kezelés

• 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
• Previous treatment with metformin (within 3 months prior to inclusion)

Más betegség

• Indication or history of lower limb angioplasty (with stenting) and/or bypass
• Chronic inflammatory disease or chronic immune-suppressive drugs intake

Laborértékek

• Creatinine clearance of less than 3 months <60 mL/mn (MDRD) at the inclusion time
• HbA1c of less than 3 months >11%

Egyéb

• Know sensitivity to metformin or to any of its excipients or placebo excipients (lactose)
• 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-human chorionic gonadotropin test) or breastfeeding woman
• Patient under legal protection measure (tutorship or curatorship) or deprived of freedom
• Unable to consent

• 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 (AME excluded)