A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms

What Was Tested

This registered phase 3 trial tested Liraglutide.

This trial is conducted in Europe, North America and the United States of America.

The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.

It had two arms (groups): Once weekly titration (experimental) and Twice weekly titration (experimental).

The registry classes the interventions as drug.

Who Took Part

420 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: Type 2 diabetes mellitus. Male or female equal to or above 18 years of age. Body Mass Index (BMI) below or equal to 40 kg/m\^2.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: impaired liver function, defined as alanine aminotransferase (alat) above or equal to 2.5 times upper normal range (unr); screening calcitonin above or equal to 50 ng/l; proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

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

It started in 2014-11-21 with completion listed for 2015-12-23.

It ran at 84 sites in United States (40), Canada (8), Austria (7), Slovakia (7), Russia (6) and Bulgaria (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in HbA1c (time frame: Week 0, week 32).

It also tracked 3 secondary outcomes, for example Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 420 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.