AbATE Follow-Up Study
NCT02067923 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44
Last updated 2018-01-17
Summary
This study proposes to conduct a non-interventional, multi-center trial that will look at C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who received anti-CD3 treatment or placebo on the Abate ITN027AI trial. Anti-CD3 monoclonal antibody is a humanized antibody that is commonly used to prevent organ rejection. It was give in order to determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1 diabetes.
The overall hypothesis of this study is there will be less change in c-peptide levels of the previously treated group versus the control group.
Conditions
- Diabetes Mellitus, Type 1
Sponsors & Collaborators
-
Yale University
lead OTHER
Principal Investigators
-
Kevan Herold, MD · Yale University
Eligibility
- Min Age
- 10 Years
- Max Age
- 37 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2016-01-31
- Completion
- 2016-11-17
Countries
- United States
Study Locations
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