Failure to Preserve beta-cell function with Mycophenolate Mofetil and Daclizumab Combined Therapy in patients with new onset Type 1 Diabetes
- Peter A. Gottlieb, MD (Peter.Gottlieb{at}ucdenver.edu),
- Scott Quinlan, MS,
- Heidi Krause-Steinrauf, MS,
- Carla J. Greenbaum, MD,
- Darrell M. Wilson, MD,
- Henry Rodriguez, MD,
- Desmond A. Schatz, MD,
- Antoinette M. Moran, MD,
- John M. Lachin, ScD,
- Jay S. Skyler, MD and
- for the Type 1 Diabetes TrialNet MMF/DZB Study Group (diabetestrialnet{at}med.miami.edu)
- Barbara Davis Center for Childhood Diabetes, University of Colorado (PAG), The Biostatistics Center, George Washington University (SQ, JM, HKS), Benaroya Research Institute (CJG), Stanford University (DMW), University of Indiana (HR), University of Florida (DAS), University of Minnesota (AMM), Diabetes Research Institute, University of Miami (JSS)
Abstract
Objective: This trial was to test whether mycophenolate mofetil (MMF) alone or with daclizumab (DZB) could arrest the loss of insulin-producing beta cells in subjects with new onset type 1 diabetes (T1D).
Research Design and Methods: A multicenter, randomized, placebo-controlled, double-masked trial was initiated by Type 1 Diabetes TrialNet at 13 sites in North America and Europe. Subjects diagnosed with type 1 diabetes and with sufficient C-peptide within 3 months of diagnosis were randomized to either: MMF-alone, MMF and DZB, or placebo, and then followed for 2 years. The primary outcome was the geometric mean area under the curve (AUC) C-peptide from the 2 hour mixed meal tolerance test.
Results: One hundred and twenty-six subjects were randomized and treated during the trial. The geometric mean C-peptide AUC at 2 years was unaffected by MMF-alone, or MMF and DZB, versus placebo. Adverse events were more frequent in the active therapy groups relative to the control group, but not significantly.
Conclusions: Neither MMF-alone nor MMF in combination with DZB had an effect on the loss of C-peptide in subjects with new onset T1D. Higher doses or more targeted immunotherapies may be needed to affect the autoimmune process.
Footnotes
-
- Received July 22, 2009.
- Accepted January 6, 2010.
- Copyright © American Diabetes Association
