CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
CTLA-4 Ig +1 moredrug
Likely dose
CTLA-4 Ig 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00505375
NCT00505375Phase 2Completed
CompareCT.gov

Effects of CTLA-4 Ig (Abatacept) On The Progression of Type 1 Diabetes In New Onset Subjects

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Jul 23, 2007·Updated May 6, 2020

In Brief

A Phase 2 clinical trial evaluating CTLA-4 Ig and Placebo for Type 1 Diabetes Mellitus. Completed, enrolled 112 participants across 13 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine whether treatment with CTLA4-Ig (Abatacept) in individuals with new onset T1DM will improve insulin secretion (C-peptide production) compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesCanada, United States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Juvenile Diabetes Research Foundation, American Diabetes Association

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 23, 2007
Enrollment StartFeb 1, 2008
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.9 years ago

Interventions

CTLA-4 Igdrug

Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses

Placeboother

Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses