A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

What Was Tested

The trial (phase 3) is built around Liraglutide.

It had four arms (groups): one (experimental), one (experimental), Placebo (placebo comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 494 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: Body mass index (BMI) 17 to 40 kg/ m\^2 inclusive.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: history of type 1 diabetes mellitus •female subject is pregnant, lactating, or \<6 weeks postpartum•; current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator; serum amylase \>=3 ×uln and/or serum lipase \>=2 × uln and/or subject is experiencing any symptoms possibly related to pancreatitis.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

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 2013-02 with completion listed for 2014-06.

It ran at 74 sites in Japan (74).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (time frame: Baseline and Week 24). Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24 (time frame: Baseline and Week 24).

It also tracked 9 secondary outcomes, for example Change From Baseline in HbA1c at Week 52, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52, Change From Baseline in Body Weight at Week 24, Change From Baseline in Body Weight at Week 52 and Time to Study Withdrawal Due to Hyperglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 494 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.