Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients

Summary

The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with Type 1 diabetes (T1D) followed by a 2-year safety follow-up.

Timeline

Start

2019-06-17

Primary completion

2020-12-21

Completion

2020-12-21

Outcome

Missed primary endpoint

Stopped: “The DSMB concluded that there was a low probability the study would meet it is primary endpoint as designed.”

registry analysis (other test); TOL-3021 vs TOL-3021 Placebo; p = 0.368; Mixed Models Analysis NCT03895437 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TOL-3021	Other / unclassified	1 mg	Intramuscular

Indications