drugset / Trial / NCT00525889
Proleukin and Rapamune in Type 1 Diabetes
Phase 1
Completed
9 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN) · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within the previous 3-48 months. The study is testing whether two immune system modifying drugs are safe when used in combination and if they have immune altering effects that indicate they can halt the progression of type 1 diabetes progression.
Timeline
- Start
- 2007-08
- Primary completion
- 2011-09
- Completion
- 2013-09
Publications
- Results Long SA, Rieck M, Sanda S, Bollyky JB, Samuels PL, Goland R, Ahmann A, Rabinovitch A, Aggarwal S, Phippard D, Turka LA, Ehlers MR, Bianchine PJ, Boyle KD, Adah SA, Bluestone JA, Buckner JH, Greenbaum CJ; Diabetes TrialNet and the Immune Tolerance Network. Rapamycin/IL-2 combination therapy in patients with type 1 diabetes augments Tregs yet transiently impairs beta-cell function. Diabetes. 2012 Sep;61(9):2340-8. doi: 10.2337/db12-0049. Epub 2012 Jun 20.
- Prevel N, Allenbach Y, Klatzmann D, Salomon B, Benveniste O. Beneficial role of rapamycin in experimental autoimmune myositis. PLoS One. 2013 Nov 12;8(11):e74450. doi: 10.1371/journal.pone.0074450. eCollection 2013.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sirolimus | Small molecule | 2 mg | Oral |
| Subject | aldesleukin | Protein / enzyme biologic | 4.5e+06 iu | Subcutaneous |