Diabetes Islet Preservation Immune Treatment

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 31, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2029

Conditions
Diabetes Mellitus, Type 1HypoglycemiaAutoimmune DiseasesDiabetes Mellitus
Interventions
DRUG

Anti-Thymocyte Globulin (ATG)

2.5 mg/kg administered as two divided infusions of 0.5 mg/kg and 2 mg/kg on Days 1 and 2.

DRUG

Interleukin 2

1 million IU per dose administered subcutaneously for 5 consecutive days on Days 10-14, and then every two weeks.

DRUG

Exenatide

2 mg administered subcutaneously weekly for up to 52 weeks.

DRUG

Adalimumab

50 mg administered subcutaneously once a month for 1 year.

OTHER

ATG Placebo

ATG placebo mimicking Thymoglobulin administered intravenously.

OTHER

IL-2 Placebo

IL-2 placebo mimicking Aldesleukin administered subcutaneously.

OTHER

Adalimumab Placebo

Placebo mimicking Adalimumab administered subcutaneously.

OTHER

Exenatide Placebo

Placebo mimicking Exenatide administered subcutaneously.

Trial Locations (1)

33136

Diabetes Research Institute, University of Miami Miller School of Medicine, Miami

All Listed Sponsors
collaborator

Diabetes Research Institute Foundation

OTHER

lead

Camillo Ricordi and Jay Skyler

OTHER