The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin 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 North and South America.

The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.

It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

451 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Body mass index (BMI) 20-45 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant; recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness; treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2012-09 with completion listed for 2013-10.

It ran at 86 sites in United States (31), Canada (11), Germany (11), Netherlands (11), India (10) and Finland (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26 (time frame: Week 0 to Week 26).

It also tracked 8 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26, Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26, Change in Body Weight From Baseline to Week 26, Number of Adverse Events (AEs) During The Randomised Treatment Period, Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period and Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 451 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.