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Proleukin® and Rapamune® in Type 1 Diabetes Mellitus (IL2-RAPA)

Principal Investigator

Carla Greenbaum | Benaroya Research Institute | Seattle, WA

Locations

Seattle, WA

Study Code

ITN018AI

Study Status

Completed

Abstract

Hypothesis: Combination therapy with IL-2 (Proleukin®) and rapamycin (Rapamune®) is safe, and will arrest pancreatic islet β-cell destruction in subjects with new-onset T1D, thereby preserving the residual β-cell mass and improving blood glucose control.

This is a single-arm, open-label, phase I(b) study in subjects with type 1 diabetes (T1DM). There will be a three-month treatment period. There will be frequent visits for safety assessments throughout the study period. In addition, assessment of diabetes control and beta cell function will be conducted every three months through the 12 month end of the trial. This is an exploratory safety study not designed or powered to examine clinical efficacy. The sample size for this study will be 10 subjects aged 18-35 years, diagnosed with T1DM within 3-48 months prior to enrollment.

 

[Clinicaltrials.gov]

Principal Investigator

Carla Greenbaum | Benaroya Research Institute | Seattle, WA

Locations

Seattle, WA

Articles

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. (2012) Rapamycin/IL-2 combination therapy in Type 1 Diabetes. Diabetes, 61 (9), 2340-8. PMID: 22721971 PMCID: PMC3425404 [PubMed] [Reprint]

The Immune Tolerance Network and is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

National Institute of Allergy and Infectious Diseases

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