NCT02586831

Diabetes Islet Preservation Immune Treatment

A Pilot, Safety and Feasibility Trial of Anti-Thymocyte Globulin (ATG), Low Dose Interleukin-2 (IL-2), Adalimumab and Exenatide in the Treatment of New-Onset Type 1 Diabetes

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Camillo Ricordi and Jay Skyler · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2015-10-26
• Last updated: 2026-01-15

Regulatory

• FDA-regulated drug study