Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

What Was Tested

This registered phase 1 trial tested Liraglutide.

This trial is conducted in Europe and the United States of America (USA).

It had four arms (groups): I.a (experimental), I.b (placebo comparator), II.a (experimental) and II.b (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 21 actual participants took part.

It was open to people of any sex aged from 10 years up to 17 years.

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

Examples of who could join: BMI greater than 85th percentile for age and gender. Currently being treated with diet and exercise or metformin alone.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: previous treatment with any anti-diabetic drug other than metformin (except for prior short term treatment, at the discretion of the trial physician).

How the Study Was Run

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

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 and investigator.

It started in 2009-11 with completion listed for 2011-09.

It ran at 20 sites in United States (14), United Kingdom (4), Belgium (1) and Slovenia (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number and type of adverse events (time frame: up to 8 weeks).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 21 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.