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

Plain-language guide to NCT01584232: phase 3 randomized trial of Insulin Glargine and Dulaglutide, 361 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01584232
Phase: phase 3
Status: completed
Start: 2012-04
Completion (planned or actual): 2013-07
Participants: 361 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes Mellitus
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and Dulaglutide.

It had two arms (groups): LY2189265 + OAM (experimental) and Insulin glargine + OAM (active comparator).

The registry classes the interventions as drug.

Who Took Part

361 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 for at least 6 months before screening. 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 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 received therapy with an alpha-glucosidase inhibitor (a-gi), thiazolidinedione (tzd), glinide, or dipeptidyl peptidase-iv (dpp-iv) inhibitor within 3 months before screening.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2012-04 with completion listed for 2013-07.

It ran at 15 sites in Japan (15).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks (time frame: Baseline, 26 weeks).

It also tracked 5 secondary outcomes, for example Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks, Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks, Change From Baseline in Body Weight at 26 Weeks and Percentage of Participants With Hypoglycemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Dulaglutide in 361 people.

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

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

Our Notes on the Compounds

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.