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ATG-GCSF in New Onset Type 1 Diabetes

NCT02215200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2020-03-02

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Anti-Thymocyte Globulin (ATG)

Thymoglobulin

DRUG

Granulocyte colony stimulating factor (GCSF)

Granulocyte colony stimulating factor (GCSF)

DRUG

Placebo (for ATG)

Normal saline administered by IV infusion to mimic ATG

DRUG

Placebo (for GCSF)

Placebo prepared to mimic 6mg subcutaneous injection of GCSF

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • American Diabetes Association

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

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

    collaborator OTHER

  • Amgen

    collaborator INDUSTRY

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Michael J Haller, M.D. · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-08-31
Completion
2018-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT02215200 on ClinicalTrials.gov