New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial

This study has been completed.
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Juvenile Diabetes Research Foundation
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00100178
First received: December 23, 2004
Last updated: July 7, 2016
Last verified: July 2016
Results First Received: May 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator)
Condition: Diabetes Mellitus, Type 1
Interventions: Drug: Mycophenolate mofeteil (MMF)
Drug: Daclizumab (DZB)
Drug: Placebo control for Mycophenolate mofeteil (MMF)
Drug: Placebo control for Daclizumab (DZB)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirteen Clinical Centers at academic institutions recruited and enrolled 126 subjects ages 8 to 45 years with autoimmune T1D for less than 3 months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened for evidence of autoantibodies and c-peptide >0.2 pmol on a stimulated 2 hr Mixed Meal Tolerance Test to determine eligibility for the study.The MMTT must be conducted at least 21 days from the diagnosis of diabetes and no more than one month (37 days) prior to the date of randomization.

Reporting Groups
  Description
MMF and DZB DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years.
MMF Alone 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
MMF-DZB Placebo Control Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later.

Participant Flow:   Overall Study
    MMF and DZB     MMF Alone     MMF-DZB Placebo Control  
STARTED     41     31 [1]   42  
COMPLETED     32     21     32  
NOT COMPLETED     9     10     10  
Lost to Follow-up                 0                 6                 5  
Adverse Event                 2                 2                 1  
Withdrawal by Subject                 1                 1                 1  
Physician Decision                 6                 1                 3  
[1] 12 subjects randomized to the MMF alone group were excluded from analysis due to randomization error



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
MMF and DZB 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years AND DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later.
MMF Alone 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years AND saline intravenous infusions given at baseline and two weeks later
MMF-DZB Placebo Control Placebo pills given daily for two years AND saline intravenous infusions given at baseline and two weeks later.
Total Total of all reporting groups

Baseline Measures
    MMF and DZB     MMF Alone     MMF-DZB Placebo Control     Total  
Number of Participants  
[units: participants]
  41     31     42     114  
Age  
[units: years]
Mean (Standard Deviation)
  18.4  (9.09)     17.1  (6.71)     18.8  (10.44)     18.2  (9.01)  
Gender  
[units: participants]
       
Female     18     11     17     46  
Male     23     20     25     68  



  Outcome Measures

1.  Primary:   Mean Stimulated C-peptide Area Under the Curve   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter Gottleib, MD
Organization: Barbara Davis Center for Childhood Diabetes, Health Sciences Center, University of Colorado
phone: 303-724-6714
e-mail: Peter.Gottleib@uchsc.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00100178     History of Changes
Other Study ID Numbers: MMFDZB (IND) (completed)
Study First Received: December 23, 2004
Results First Received: May 13, 2016
Last Updated: July 7, 2016
Health Authority: United States: Food and Drug Administration