A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide.

This trial is conducted in Asia.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 210 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. T2DM (type 2 diabetes mellitus) subjects (diagnosed clinically) for at least 6 months prior to screening. Body Mass Index (BMI) equal or above 23 kg/m\^2.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: receipt of any investigational medicinal product (imp) within 30 days before screening; screening calcitonin equal or above 50 ng/l; history of pancreatitis (acute or chronic).

How the Study Was Run

It was run as a randomized, parallel-group and double-blind 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.

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 2016-09-21 with completion listed for 2017-11-17.

It ran at 38 sites in Japan (38).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c) (time frame: week 0, week 26).

It also tracked 27 secondary outcomes, for example Change in Body Weight, Change in Fasting Plasma Glucose (FPG), Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes, Change in Waist Circumference, Change in Blood Pressure (Systolic and Diastolic) and Self-measured Blood Glucose (SMBG) 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 210 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.