Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

What Was Tested

This registered phase 2 trial tested Liraglutide.

It had two arms (groups): Victoza® (active comparator) and Placebo (placebo comparator).

Subjects with preclinical type 1 diabetes aged 18-30 years are treated with Victoza® (liraglutide).

Subjects with preclinical type 1 diabetes aged 18-30 years are treated with placebo.

The registry classes the interventions as drug.

Who Took Part

42 planned participants were the target.

It was open to people of any sex aged from 18 years up to 30 years.

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

Examples of who could join: 18-30 years of age. Positive for at least 2 biochemical islet autoantibodies. Have normal glucose tolerance in OGTT. Are not pregnant.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: allergic to liraglutide or other ingredients of victoza®; type 1 diabetes; diabetic ketoacidosis.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-12 with completion listed for 2024-06.

It ran at 3 sites in Finland (3).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: FPIR (first phase insulin response) (time frame: From baseline to 26 and 104 weeks).

It also tracked 3 secondary outcomes, for example Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia, Tolerability and Serum C-peptide AUC.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 42 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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