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ACTIVE NOT RECRUITING
NCT03941132
PHASE2/PHASE3

Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2)

Sponsor: University of British Columbia

View on ClinicalTrials.gov

Summary

In type 1 diabetes (T1D), immune defense cells in the body attack and destroy insulin-producing beta cells leaving affected people with a lifelong need for daily insulin injections. Even with insulin injections, blood glucose (sugar) control is imperfect and leads to many health complications and a shortened life span. Our pilot study (NCT02117765) has informed us that Ustekinumab is safe in the treatment of participants with recent-onset T1D. Ustekinumab is currently licensed for use in psoriasis where it has proven to be both highly effective and safe. The investigators hope that if the drug can block immune cells soon after the development of diabetes, any remaining insulin-producing cells may be protected, and regenerate, thus producing more insulin so that individuals may be insulin free, or require less insulin. This trial will assess the efficacy of Ustekinumab in decreasing C-peptide decline (proxy for endogenous insulin production) in participants with recent onset T1D.

Key Details

Gender

All

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2021-01-04

Completion Date

2026-11-01

Last Updated

2025-02-24

Healthy Volunteers

No

Interventions

DRUG

Ustekinumab

Week 0: Loading dose of 6mg/kg Ustekinumab Intravenously. Weeks 8, 16, 24, 32, 40, and 48 (6 visits): 90mg Ustekinumab subcutaneously.

DRUG

Placebo

Patients allocated to receive placebo will receive respective amounts of a saline-placebo at the same intervals. Week 0: Loading dose of 6mg/kg saline intravenously. Weeks 8, 16, 24, 32, 40, and 48 (6 visits): 90mg saline subcutaneously.

Locations (2)

Mount Sinai Hospital/UHN

Toronto, British Columbia, Canada

BCDiabetes

Vancouver, British Columbia, Canada