Incretin-based Therapy in Late Preclinical Type 1 Diabetes

What Was Tested

The trial (phase 2) is built around Liraglutide.

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

Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza®.

Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with placebo.

The registry classes the interventions as drug.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex aged from 10 years up to 30 years.

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

Examples of who could join: 10-30 years of age. Positive for at least 2 islet autoantibodies.

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

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

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

It started in 2016-03 with completion listed for 2021-06.

It ran at 4 sites in Finland (3) and Sweden (1).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: FPIR (1+3min serum insulin level after iv glucose infusion) (time frame: 12 months).

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 13 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.