A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Dulaglutide.

It had two arms (groups): Dulaglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 159 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. Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2).

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: participants who have a diagnosis of type 1 diabetes; participants who have previously received therapy with a glucagon-like peptide-1 receptor agonist within 3 months prior to screening; participants who have been previously treated with dulaglutide prior to screening.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Dulaglutide and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Dulaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2016-08 with completion listed for 2018-06-18.

It ran at 25 sites in Japan (25).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 16).

It also tracked 5 secondary outcomes, for example Change From Baseline in Fasting Serum Glucose (FSG), Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG) and Change From Baseline in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Dulaglutide in 159 people.

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

More context: the Dulaglutide compound page, all human trials.