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

What Was Tested

This registered phase 3 trial tested Liraglutide.

This trial is conducted globally.

Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.

It had three arms (groups): IDeg (experimental), IDegLira (experimental) and Lira (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 1663 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. Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital). Body Mass Index (BMI) maximum 40 kg/m\^2.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the investigator); treatment with glp-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (dpp-4) inhibitors within 90 days prior to trial; screening calcitonin at least 50 ng/l.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

It started in 2011-05-23 with completion listed for 2012-05-24.

It ran at 302 sites in United States (146), India (23), United Kingdom (17), Canada (15), Germany (14) and South Africa (14).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 4 secondary outcomes, for example Mean Change From Baseline in Body Weight at Week 26, Number of Hypoglycaemic Episodes and Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 1663 people.

With 1663 participants it is a large trial for this field.

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.