Diabetes Islet Preservation Immune Treatment

Summary

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

Conditions

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Autoimmune Diseases
• Diabetes 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.

Sponsors & Collaborators

• Diabetes Research Institute Foundation

  collaborator OTHER

• Camillo Ricordi and Jay Skyler

  lead OTHER

Principal Investigators

• Rodolfo Alejandro, M.D. · Diabetes Research Institute, University of Miami

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2024-06-01

Completion

2024-06-01

FDA Drug

Yes