Type 1 diabetes, recently diagnosed
Conditions
Interventions
Trade Name: CellCept
Product Name: Mycophenolate mofetil
Product Code: MMF
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
George Washington University Biostatistics Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - first diagnose of type 1 diabetes within the last 3 months - age 18-35 years - mixed meal-stimulated C-peptide > 0,2 pmol/ml - detectable islet autoantibodies 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: - Body Mass Index (BMI) >95. percentile for age and sex - serological signs of HBV, HCV or HIV-infection - impaired liver function - leuco- and/or neutropenia (present or past) - chronic gastrointestinal ulcera, erosive esophagitis, inflammatory bowel disease (present or past) - positive tuberculine reaction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Preservation of residual beta cell function;Secondary Objective: 1. To reach and maintain stability of metabolic control with normal or nearly normal blood glucose levels. 2. To avoid or delay secondary complications of diabetes.;Primary end point(s): stimulated C-peptide (area under the curve) over the first 2 hours of a 4-hour mixed meal tolerance test in month 24 | — |
Countries
Germany, Italy
Outcome results
None listed