A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Dulaglutide.

It had three arms (groups): one (active comparator), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 1842 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Have type 2 diabetes mellitus (T2DM) for at least 6 months. Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m\^2).

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have used any glucagon-like peptide-1 receptor agonist (glp-1 ra) or insulin, not including prior short term insulin use (≤14 days); have been taking any other medicine for diabetes (other than metformin) during the last 3 months.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Dulaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2018-04-05 with completion listed for 2019-05-28.

It ran at 208 sites in United States (72), Argentina (17), Romania (17), Poland (15), Spain (14) and Greece (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Hemoglobin A1c (HbA1c) From Baseline (time frame: Baseline, Week 36).

It also tracked 6 secondary outcomes, for example Change in Body Weight From Baseline, Change in Fasting Serum Glucose (FSG) From Baseline and Rate of Documented Symptomatic Hypoglycemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Dulaglutide in 1842 people.

With 1842 participants it is a large trial for this field.

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.