Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human) and Liraglutide.

This trial is conducted in Asia.

Subjects will remain on their pre-trial insulin therapy.

It had two arms (groups): Lira+Insulin (experimental) and Placebo+Insulin (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

257 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: Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months. Body Mass Index (BMI) below 45.0 kg/m\^2.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: known proliferative retinopathy or maculopathy requiring treatment according to the investigator; treatment with glucagon-like peptide-1 (glp-1) receptor agonist within 12 weeks prior to screening; treatment with any oral antidiabetic drugs (oads) within 12 weeks prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant and investigator.

It started in 2012-04-05 with completion listed for 2012-11-01.

It ran at 23 sites in Japan (23).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16 (time frame: Week 0, Week 16).

It also tracked 11 secondary outcomes, for example Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36, Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16, Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36, Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16, Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36 and Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Liraglutide in 257 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page and the Liraglutide compound page, all human trials.