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Reversing Type 1 Diabetes After it is Established

NCT01106157 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-08-05

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Anti-Thymocyte Globin (ATG)

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

DRUG

Placebo

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

DRUG

Pegylated GCSF

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

Sponsors & Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Michael J. Haller, MD · University of Florida Pediatric Endocrinology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-01-31
Completion
2019-07-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01106157 on ClinicalTrials.gov