Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Liraglutide.

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

Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30 years, and treated with insulin are treated with Victoza®.

Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30, and treated with insulin are treated with placebo.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 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. Early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT).

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: allergic to liraglutide or other ingredients of victoza®; diabetic ketoacidosis; previous treatment in the last three months with any antidiabetic medication other than insulin.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

The Liraglutide group and the comparison group ran side by side rather than switching.

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 2021-05.

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

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Serum C-peptide AUC (time frame: From baseline to 26 and 52 weeks).

It also tracked 4 secondary outcomes, for example Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored, Number of hypoglycemia episodes and Frequency of gastrointestinal side effects.

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.