Intervention with mycophenolate mofetil and daclizumab in patients with recently diagnosed type 1 diabetes mellitus - MMF/DZB Studie
- Conditions
- Type 1 diabetes, recently diagnosed
- Registration Number
- EUCTR2005-000904-15-DE
- Lead Sponsor
- George Washington University Biostatistics Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>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
- Secondary Outcome Measures
Name Time Method