A Study of LY2189265 in Japanese Patients With Type 2 Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Dulaglutide.

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

The registry classes the interventions as drug.

Who Took Part

145 actual participants took part.

It was open to people of any sex aged from 20 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Japanese patients with type 2 diabetes with a body mass index (BMI)≥18.5 kilograms per square meter (kg/m\^2) but \<40.0 kg/m\^2. Patients who are oral antidiabetic drug (OAD) naïve or are taking OAD monotherapy except for a dipeptidyl peptidase-4 inhibitor (DPP-IV) and are willing to discontinue their OAD. Patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: patients who are currently taking prescription medications to promote weight loss; patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening; patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension.

How the Study Was Run

Design: randomized, parallel-group and triple-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.

Blinding on both sides kept the participants and researchers unaware of who received Dulaglutide.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2009-10 with completion listed for 2010-12.

It ran at 6 sites in Japan (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks (time frame: Baseline, 12 weeks).

It also tracked 9 secondary outcomes, for example Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks, Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks, Change From Baseline in Total Body Weight at 12 Weeks, Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks, Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks and Steady-State Concentrations of LY2189265.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 145 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.