ew onset type 1 diabetes Mycophenolate Mofetil Daclizumab clincal trial - MMF/DZB in T1DM
- Conditions
- Type 1 Diabetes MellitusMedDRA version: 9.1Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependent
- Registration Number
- EUCTR2005-000904-15-IT
- Lead Sponsor
- IDDK TYPE 1 DIABETES TRIALNET
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 126
Inclusion Criteria
Type 1 diabetes within 3 months of diagnosis; Between the ages of 18 and 45 years; Stimulated C-peptide ≥ 0.2 pmol/ml; Detectable beta cell autoantibodies.
Are the trial subjects under 18? yes
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
Complicating Medical conditions; Serologic evidence of HIV, HCV or Hep B, History of leucopenia and/or neutropenia; Abnormal liver function tests; Positive PPD; Live vaccinations in 6 weeks preceeding randomizzation; Refusal to use birth control; Pregnancy/ nursing/ 3 months post partum
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the ability of two immunosuppresive therapies (MMF alone or in combination with DZB, both compared to placebo) to arrest the ongoing Beta cell distruction in recently diagnosed type 1 diabetes. Outcome measure is the area under stimulated C-peptide curve after mixed meal tolerance test(MMTT);Secondary Objective: Glycosylated hemoglobin (HbA1c). Number of hypoglycemic events. Number of major hypoglycemic events.;Primary end point(s): Area under stimulated C-peptide curve over the first 2 hours of a 4-hour MMTT administered at Month 24.
- Secondary Outcome Measures
Name Time Method