Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D

What Was Tested

The trial (early phase 1) is built around Liraglutide.

It had two arms (groups): Liraglutide (experimental) and Golimumab (experimental).

Participants will receive subcutaneous (SC) liraglutide for 8 weeks.

Participants will receive subcutaneous (SC) golimumab for 8 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Males and females 18-50 years of age, inclusive. Proinsulin levels ≥ 2 pM (either fasting or stimulated). Willing and able to give informed consent for participation.

The full record lists 7 inclusion and 29 exclusion criteria; among the exclusions: concurrent use of non-insulin therapies aimed to control hyperglycemia or use within the past 30 days of screening mmtt (v-2); history of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies; diagnosis of liver disease or elevated hepatic enzymes, as defined by alt or ast\> 1.5 x the upper limit of age-determined normal (uln) .

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-08-15 with completion listed for 2021-11-09.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Liraglutide in 16 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.