CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 89 enrolled
Drug / intervention
Anti-Thymocyte Globulin (ATG) +3 moredrug
Likely dose
Placebo (for GCSF) 6mgfrom 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/NCT02215200
NCT02215200Phase 2Completed
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Antithymocyte Globulin (ATG) and Pegylated Granulocyte Colony Stimulating Factor (GCSF) in New Onset Type 1 Diabetes

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Aug 13, 2014·Updated Mar 2, 2020

In Brief

A Phase 2 clinical trial evaluating Anti-Thymocyte Globulin (ATG), Granulocyte colony stimulating factor (GCSF), and 2 other interventions for Diabetes Mellitus, Type 1. Completed, enrolled 89 participants across 13 sites.

Detailed Summary

This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1 Diabetes (T1D). The primary objective of the study will be to determine the safety and ability of low dose ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D patients demonstrating residual beta cell function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR), Juvenile Diabetes Research Foundation, American Diabetes Association, Sanofi, The Leona M. and Harry B. Helmsley Charitable Trust, Amgen

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 13, 2014
Enrollment StartDec 1, 2014
Primary CompletionAug 1, 2017
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.9 years ago

Interventions

Anti-Thymocyte Globulin (ATG)drug

Thymoglobulin

Granulocyte colony stimulating factor (GCSF)drug

Granulocyte colony stimulating factor (GCSF)

Placebo (for ATG)drug

Normal saline administered by IV infusion to mimic ATG

Placebo (for GCSF)drug

Placebo prepared to mimic 6mg subcutaneous injection of GCSF