AbATE Follow-Up Study

Completed

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT02067923

Run by

Yale University

People needed

44

Starts

2014-02-01

Expected to finish

2016-11-17

Last updated by the study team

2018-01-17

Who can join

Age: 10 and older, up to 37. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior participation on either the treatment or the control arm of the Abate ITN027AI trial
• Signed Informed Consent

You may not qualify if…

• Inability or unwillingness to give informed consent
• Participation in an investigational treatment trial within the last 6 weeks before enrollment
• Ongoing major systemic illness.
• Clinically active serious infections.
• Any medical condition that in the opinion of the investigator would interfere with safe completion of the trial.
• Positive pregnancy test in menstruating women
• Actively breast feeding

Where it is running

• Church Street Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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