CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 145 enrolled
Drug / intervention
GAD-Alum +2 moredrug
Likely dose
GAD-Alum 20 microgramsfrom 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/NCT00529399
NCT00529399Phase 2Completed
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Effects of Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) Formulated in Alum (GAD-alum) on the Progression of Type 1 Diabetes in New Onset Subjects

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Sep 14, 2007·Updated May 7, 2020

In Brief

A Phase 2 clinical trial evaluating GAD-Alum, GAD-Alum and Aluminum hydroxide, and 1 other intervention for Type 1 Diabetes Mellitus. Completed, enrolled 145 participants across 15 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine whether treatment with multiple injections of GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have been recently diagnosed with type 1 diabetes mellitus (T1DM).

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2007
Enrollment StartFeb 1, 2009
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.8 years ago

Interventions

GAD-Alumdrug

Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.

GAD-Alum and Aluminum hydroxidedrug

Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.

Aluminum hydroxidedrug

Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.