A Study of Dulaglutide (LY2189265) in Participants With Type II Diabetes

What Was Tested

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

The main purpose of this study is to evaluate the use of the study drug known as dulaglutide in participants with type II diabetes who are taking once-daily insulin glargine.

The study will last about 31 weeks for each participant.

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

The registry classes the interventions as drug.

Who Took Part

300 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 (based on the World Health Organization's \[WHO\] diagnostic criteria). Have been treated with basal insulin glargine once daily with or without metformin for at least 3 months prior to screening. Have body mass index (BMI) ≤45 kilograms per square meter (kg/m\^2) at screening. Are able and willing to administer once weekly randomized therapy. Are females of childbearing potential who must:.

The full record lists 12 inclusion and 20 exclusion criteria; among the exclusions: have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma; have a history of hypoglycemia unawareness within the 6 months prior to screening; have been treated with drugs that promote weight loss within the 3 months prior to screening or between screening and week 3.

How the Study Was Run

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

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.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2014-05 with completion listed for 2015-10.

It ran at 40 sites in United States (13), Puerto Rico (6), Czechia (5), Spain (5), Italy (4) and United Kingdom (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c) (time frame: Baseline, 28 Weeks).

It also tracked 15 secondary outcomes, for example Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG), Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG), Change From Baseline to 28 Weeks in Body Weight, Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events, Percentage of Participants With Self-Reported Events of Hypoglycemia and Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Dulaglutide in 300 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.