The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy

What Was Tested

This registered phase 3 trial tested Liraglutide.

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

It had two arms (groups): Insulin degludec/liraglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 435 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 mellitus. Body Mass Index (BMI) below or equal to 40 kg/m\^2.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: previous treatment with glucagon-like peptide-1 (glp-1) receptor agonist (e.g. exenatide, liraglutide); treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator); screening calcitonin above or equal to 50 ng/l.

How the Study Was Run

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

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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 and investigator.

It started in 2012-08-29 with completion listed for 2013-10-23.

It ran at 87 sites in United States (44), Canada (10), India (8), Germany (7), Israel (7) and Bulgaria (5).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 6 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG), Change From Baseline in Body Weight, Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes and Number of Adverse Events (AEs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 435 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.