A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Liraglutide and Dulaglutide.

It had three arms (groups): LY2189265 (experimental), Placebo/LY2189265 (placebo comparator) and Liraglutide (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 492 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: Participants who have had a diagnosis of type 2 diabetes mellitus before screening. Participants who have a body mass index (BMI) of 18.5 kilograms per meter squared (kg/m\^2) to 35.0 kg/m\^2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: participants who have a diagnosis of type 1 diabetes; participants who have previously been treated with any other glucagon-like peptide-1 (glp-1) analog; participants who have been currently taking insulin or tzd, or have had previous insulin or tzd treatment within 3 months before screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-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, care provider, investigator and outcomes assessor.

It started in 2012-03 with completion listed for 2013-10.

It ran at 14 sites in Japan (14).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks (time frame: Baseline, 26 weeks).

It also tracked 18 secondary outcomes, for example Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks, Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks, Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks, Change From Baseline in Body Weight at 26 Weeks and 52 Weeks, Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks and Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide and Dulaglutide in 492 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 and the Dulaglutide compound page, all human trials.