NCT02215200

ATG-GCSF in New Onset Type 1 Diabetes

Antithymocyte Globulin (ATG) and Pegylated Granulocyte Colony Stimulating Factor (GCSF) in New Onset Type 1 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary statistical hypothesis to be assessed in the study is whether the 2 hour area under the curve (change in baseline to 12 months) in residual beta cell function (C-peptide) will differ between those treated with ATG and GCSF or ATG alone as compared with placebo. The study will also examine the effect of the proposed treatments on surrogate markers for immunologic and metabolic outcomes.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-08-01
• Completion: 2018-08-01
• First posted: 2014-08-13
• Last updated: 2020-03-02
• Results posted: 2020-03-02

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study