A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Dulaglutide.

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

Placebo given SC once a week for 24 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 424 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 (based on the World Health Organization's \[WHO\] diagnostic criteria).

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; had chronic or acute pancreatitis any time prior to study entry; have any self or family history of medullary c-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial, or part of men 2a or 2b syndrome).

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.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2015-11 with completion listed for 2017-02.

It ran at 41 sites in United States (13), Czechia (6), Hungary (4), Spain (4), Austria (3) and Israel (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand) (time frame: Baseline, Week 24).

It also tracked 9 secondary outcomes, for example Change From Baseline in Body Weight at 24 Weeks, Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks, Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks, Change From Baseline in Fasting Glucagon at 24 Weeks, Rate of Hypoglycemic Events Adjusted Per 30 Days and Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Dulaglutide in 424 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.