Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Insulin (regular human).

A total of 96 participants are planned for enrollment, including 32 in the dimethyl fumarate treatment group and 64 in the standard-treatment control group.

It had two arms (groups): Dimethyl Fumarate Plus Standard Insulin Therapy (experimental) and Standard Insulin Therapy (active comparator).

Participants in this arm will receive standard insulin therapy for type 1 diabetes without dimethyl fumarate. Participants will be followed according to the study schedule for 24 weeks of treatment observation and 52 weeks of follow-up.

The registry classes the interventions as drug.

Who Took Part

The registry lists 96 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Willing and able to participate in the study and provide signed informed consent. Aged 18 to 65 years. Diagnosed with type 1 diabetes mellitus according to ADA 2024 criteria.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: pregnant or breastfeeding women, positive urine pregnancy test at screening, or inability to rule out pregnancy in the opinion of the investigator; good glycemic control with oral antidiabetic drugs alone; participation in other studies involving diabetes treatment or immunomodulation.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2026-04-27 with completion listed for 2028-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Baseline-Adjusted Geometric Mean Area Under the Serum C-Peptide Curve During a 2-Hour Mixed-Meal Tolerance Test (time frame: 24 weeks after end of intervention (48 weeks after enrollment)).

It also tracked 24 secondary outcomes, for example Baseline-Adjusted Geometric Mean Area Under the Serum C-Peptide Curve During a 2-Hour Mixed-Meal Tolerance Test, Change From Baseline in Geometric Mean Area Under the Serum C-Peptide Curve During a 2-Hour Mixed-Meal Tolerance Test, Number of Participants Maintaining Positive C-Peptide Response After a 2-Hour Mixed-Meal Tolerance Test, Glycated Hemoglobin (HbA1c), Number of Participants With Poor Glycemic Control and Number of Participants With Good Glycemic Control.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, non-randomized trial of Insulin (regular human) in 96 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.