A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide.

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

Subjects continue their pre-trial treatment with metformin throughout the entire trial.

It had two arms (groups): IDegLira + metformin (experimental) and IDeg + metformin (experimental).

IDegLira was injected subcutaneously once daily for 26 weeks.

IDeg was injected subcutaneously once daily for 26 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 413 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Subjects with type 2 diabetes. BMI (Body Mass Index) more than or equal to 27 kg/m\^2.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: treatment with glucagon like peptide-1 (glp-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (dpp-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start; impaired liver function; impaired renal function.

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 2011-11-28 with completion listed for 2012-10-01.

It ran at 86 sites in United States (58), Bulgaria (6), India (6), Switzerland (6), Hungary (4) and Denmark (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 26).

It also tracked 1 secondary outcome, for example Change in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 413 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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