A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin

What Was Tested

The trial (phase 2, phase 3) is built around Dulaglutide.

It had nine arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

The final endpoint is 104 weeks.

All participants will remain blinded to their study treatment throughout the study.

Who Took Part

The registry lists 1202 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Diabetes mellitus, type 2, for at least 6 months. Body mass index (BMI) between 25 and 40 kilograms per meter squared (kg/m\^2), inclusive. Stable weight for 3 months prior to screening. Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: diabetes mellitus, type 1; use of a glucagon-like peptide-1 (glp-1) analog (for example, exenatide) within 6 months prior to screening or are being treated with insulin; gastric emptying abnormality, history of bariatric surgery, or chronic use of drugs that affect gastrointestinal motility.

How the Study Was Run

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

The participants were allocated by chance, so the Dulaglutide 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 Dulaglutide 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 2008-08 with completion listed for 2011-06.

It ran at 99 sites in United States (35), Germany (12), France (9), Taiwan (7), India (5) and Poland (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glycosylated Hemoglobin (HbA1c) Change From Baseline (time frame: Baseline, 52 weeks).

It also tracked 30 secondary outcomes, for example Glycosylated Hemoglobin (HbA1c) Change From Baseline, Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c), Fasting Blood Glucose Change From Baseline, Fasting Insulin Change From Baseline, Body Weight Change From Baseline and Durability of Change From Baseline Body Weight.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Dulaglutide in 1202 people.

With 1202 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.