Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2)
Status:
Recruiting
Trial end date:
2025-08-01
Target enrollment:
Participant gender:
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.