Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft (GRAGIL1)

Inclusion Criteria:

• Type 1 diabetes mellitus
• Disease duration > 5 years
• ketose antecedents
• Basal and stimulated plasma C-< 0.2 ng/ml,<0.06 nmol/l (glycemia must be measured simultaneously_ 1.20 g/l or 6.6 mM, stimulation with glucagon IV 1 mg -Measured at à T0 and T 6 min)
• Established kidney graft ≥ 6 months
• Current creatinine clearance: ≥ 50 ml/min/1.73 m² and Proteinuria < 0.5 g/24h
• HbA1C< 12%

Exclusion Criteria:

• Hemostasis problems
• Documented hepatic pathology
• Patient under 18 or over 65 year-old
• Women with body weight over 70 kg (tolerance of 2 kg between inclusion day and transplantation day) or BMI > 26
• Men with body weight > 75 kg (tolerance of 3 kg between inclusion day and transplantation day) or BMI > 26
• insuline needs > 0.7 U/kg/j or 50 U/j
• Serious life-threatening pathology
• untreated hyperlipidemia
• Hypersensitivity to drugs rapamycine-alike
• Liver disease (transaminases or total bilirubin ≥ 3N)
• Failure to communicate or cooperate with the investigator

Exclusion criteria that are specific to the use of Rapamycine

• Hypercholesterolemia (> 350mg/dl, 9,1 mmol/l) not controlled
• Hypertriglyceridemia (> 500 mg/dl, 5,6 mmol/l) not controlled
• Leukocytes > 4500 /mm3 , neutrophils > 2000/ mm3, platelets > 100000/ mm3
• Any clinical or biological pathology that could interfere with the study
• Past or present neoplasia (with the exception of non melanoma skin cancers)
• Any hemostasis disorder needing a prolonged treatment with anticoagulation drugs. Low-dose aspirin is permitted.
• Pregnancy, lactation, pregnancy project or absence of efficient contraception
• Any medical or psychosocial condition susceptible to interfere with the study, such as drug abuse or recent alcohol abuse