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

What Was Tested

This registered phase 3 trial tested Liraglutide.

This trial is conducted in Asia.

It had three arms (groups): Insulin degludec/liraglutide OD (experimental), Insulin degludec OD (active comparator) and Liraglutide OD (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 819 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

Examples of who could join: Male or female Japanese subjects, age at least 20 years at the time of signing informed consent. Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening. Body-mass index (BMI) above or equal to 20 kg/m\^2.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes); anticipated initiation or change in concomitant medications in excess of 14 days known to affect weight or glucose metabolism; impaired liver function, defined as alanine aminotransferase (alt) or aspartate aminotransferase (ast) equal to or above 2.5 times upper limit of normal.

How the Study Was Run

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

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 2015-11-18 with completion listed for 2017-12-15.

It ran at 76 sites in Japan (76).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 39 secondary outcomes, for example Change From Baseline in Body Weight (kg), Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes, Change From Baseline in Fasting Plasma Glucose (FPG), Change in Waist Circumference, Change in Blood Pressure (Systolic and Diastolic) and Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 819 people.

With 819 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.