New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial (TN02)
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ClinicalTrials.gov Identifier: NCT00100178 |
Recruitment Status :
Completed
First Posted : December 24, 2004
Results First Posted : August 16, 2016
Last Update Posted : May 5, 2020
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Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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)
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Other |
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) |
Enrollment | 126 |
Participant Flow
Recruitment Details | 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 | 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. |
Arm/Group Title | MMF and DZB | MMF Alone | MMF-DZB Placebo Control |
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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. | 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. | Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later. |
Period Title: Overall Study | |||
Started | 41 | 31 [1] | 42 |
Completed | 32 | 21 | 32 |
Not Completed | 9 | 10 | 10 |
Reason Not Completed | |||
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
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Baseline Characteristics
Arm/Group Title | MMF and DZB | MMF Alone | MMF-DZB Placebo Control | Total | |
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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. | 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 | Placebo pills given daily for two years AND saline intravenous infusions given at baseline and two weeks later. | Total of all reporting groups | |
Overall Number of Baseline Participants | 41 | 31 | 42 | 114 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 41 participants | 31 participants | 42 participants | 114 participants | |
18.4 (9.09) | 17.1 (6.71) | 18.8 (10.44) | 18.2 (9.01) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 41 participants | 31 participants | 42 participants | 114 participants | |
Female |
18 43.9%
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11 35.5%
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17 40.5%
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46 40.4%
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Male |
23 56.1%
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20 64.5%
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25 59.5%
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68 59.6%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |
EMail: | Peter.Gottleib@uchsc.edu |
Other 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 |
Other Study ID Numbers: |
TN02 MMF/DZB U01DK061055 ( U.S. NIH Grant/Contract ) UC4DK097835 ( U.S. NIH Grant/Contract ) |
First Submitted: | December 23, 2004 |
First Posted: | December 24, 2004 |
Results First Submitted: | May 13, 2016 |
Results First Posted: | August 16, 2016 |
Last Update Posted: | May 5, 2020 |