Liraglutide in Newly Onset Type 1 Diabetes.

What Was Tested

The trial (phase 2, phase 3) is built around Liraglutide.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 65 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Age 18 - 40 years - both inclusive. Able to understand the written patient information and to give informed consent.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: body mass index \<20 kg/m2; liver disease with elevated plasma alanine aminotransferase (alt) \> three times the upper limit of normal at visit 0.

How the Study Was Run

The set-up was randomized, parallel-group and triple-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.

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

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

It started in 2014-02 with completion listed for 2018-08.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Beta-cell function (time frame: 52 weeks).

It also tracked 1 secondary outcome, for example Postprandial glucagon.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Liraglutide in 65 people.

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.