tipe I dyabete MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Trade Name: RAPAMUNE
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Sirolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Trade Name: THYMOGLOBULIN
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: male and female patients aged from 18 to 65 years old; type I diabete; duration of disease > 5 years; metabolic instability, with frequent episodes of hypoglicemia; two or mor hospitalization/year for chetoacidosis; cronic complincations of diabete in quick progression (retinopathy, periferic neuropathy) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. BMI >27 kg/m2 2. Insulin requirement of > 0.8 IU/kg/day. 3. HbA1c >12%. 4. Untreated proliferative diabetic retinopathy. 5. uncontrolled hypertension. 6. Measured glomerular filtration rate 300mg/g day) 8. Presence or history of panel-reactive anti-HLA antibodies >20% by flow cytometry. For subjects with panel reactive anti-HLA antibodies above background but ≤ 20%, if the antigen specificity of the antibodies can be determined for future avoidance they can be included; however, if the antigen specificity of the antibodies cannot be determined they will be excluded. 9. For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3 months after discontinuation. For male participants: intent to procreate during the duration of the study or within 3 months after discontinuation or unwillingness to use effective measures of contraception.. 10. Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB. 11. Negative screen for Epstein-Barr Virus (EBV) by IgG determination. 12. Any history of malignancy within the previous 5 years except for completely resected squamous or basal cell carcinoma of the skin. Previous breast cancer and melanoma constitute an absolute contraindication. 13. Known active alcohol or substance abuse. 14. Baseline Hgb below the lower limits of normal at the local laboratory; lymphopenia (1.5. 16. Severe co-existing cardiac disease, characterized by any one of these conditions i. recent myocardial infarction (within past 6 months). ii. evidence of ischemia on functional cardiac exam within the last year. iii. left ventricular ejection fraction 1.5 times normal upper limits will exclude a patient. 18. Symptomatic cholecystolithiasis. 19. Acute pancreatitis. 20. Severe unremitting diarrhea, vomiting or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications. 21. Hyperlipidemia despite medical therapy (fasting LDL cholesterol > 130 mg/dl (3.36 mmol/l), treated or untreated; and/or fasting triglycerides > 200 mg/dl (2.26 mmol/l) 22. Receiving treatment for a medical condition requiring chronic use of systemic steroids. 23. Use of any investigational agents within 4 weeks of enrollment. 24. Administration of live attenuated vaccine(s) within 2 months of enrollment. 25. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: treatment of type I diabete in failure by transplantation of pancreatic islands with an immunosoppressive protocol equal or superior to Edmonton protocol.Glicemic control normalization.;Secondary Objective: treatment of type I diabete in failure by transplantation of pancreatic islands with an immunosoppressive protocol equal or superior to Edmonton protocol.Glicemic control normalization.;Primary end point(s): Glicemic control normalization. | — |
Countries
Italy
Outcome results
None listed