drugset / Trial / NCT01106157
Reversing Type 1 Diabetes After it is Established
Phase 1/2
Completed
25 enrolled
University of Florida
Genzyme, a Sanofi Company · collabThe Leona M. and Harry B. Helmsley Charitable Trust · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2010-04
- Primary completion
- 2015-01
- Completion
- 2019-07-16
Outcome
Met primary endpoint
registry p = 0.017; Mean Difference (Net) 0.277 (95% CI 0.001 to 0.552) NCT01106157 ↗
Publications
- Background Parker MJ, Xue S, Alexander JJ, Wasserfall CH, Campbell-Thompson ML, Battaglia M, Gregori S, Mathews CE, Song S, Troutt M, Eisenbeis S, Williams J, Schatz DA, Haller MJ, Atkinson MA. Immune depletion with cellular mobilization imparts immunoregulation and reverses autoimmune diabetes in nonobese diabetic mice. Diabetes. 2009 Oct;58(10):2277-84. doi: 10.2337/db09-0557. Epub 2009 Jul 23.
- Haller MJ, Gitelman SE, Gottlieb PA, Michels AW, Rosenthal SM, Shuster JJ, Zou B, Brusko TM, Hulme MA, Wasserfall CH, Mathews CE, Atkinson MA, Schatz DA. Anti-thymocyte globulin/G-CSF treatment preserves beta cell function in patients with established type 1 diabetes. J Clin Invest. 2015 Jan;125(1):448-55. doi: 10.1172/JCI78492. Epub 2014 Dec 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anti-Thymocyte Globin (ATG) | Protein / enzyme biologic | 2.5 mg/kg | Intravenous |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |