CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Anti-Thymocyte Globin (ATG) +2 moredrug
Likely dose
Anti-Thymocyte Globin (ATG) 2mg/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/NCT01106157
NCT01106157Phase 2Completed
CompareCT.gov

Reversing Type 1 Diabetes After it is Established: A Pilot Safety and Feasibility Study of Anti-Thymocyte Globulin (Thymoglobulin®)and Pegylated GCSF (Neulasta®) in Established Type 1 Diabetes

University of Florida·interventional·Posted Apr 19, 2010·Updated Aug 5, 2019

In Brief

A Phase 2 clinical trial evaluating Anti-Thymocyte Globin (ATG), Placebo, and 1 other intervention for Diabetes Mellitus, Type 1. Completed, enrolled 25 participants across 3 sites.

Detailed Summary

The primary purpose of this study is to determine if giving the combination therapy consisting of Thymoglobulin® (ATG) and Neulasta® (GCSF) to patients with established Type 1 Diabetes (T1D) is safe and secondarily, if the ATG and GCSF will preserve insulin production.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
CollaboratorsThe Leona M. and Harry B. Helmsley Charitable Trust, Genzyme, a Sanofi Company

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 19, 2010
Enrollment StartApr 1, 2010
Primary CompletionJan 1, 2015
Study CompletionJul 16, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 16.2 years ago

Interventions

Anti-Thymocyte Globin (ATG)drug

Anti-Thymocyte Globin (ATG) will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2.

Placebodrug

Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes

Pegylated GCSFdrug

6 doses of pegylated GCSF (6mg/dose) will be given subcutaneously every 2 weeks beginning after the ATG infusion.