A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Liraglutide and Dulaglutide.

It had two arms (groups): one (experimental) and Liraglutide (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 599 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: Type 2 diabetes. Accept continued treatment with metformin throughout the trial, as required per protocol. Men and nonpregnant women aged greater than or equal to 18 years. Body Mass Index (BMI) less than or equal to 45 kilograms/square meter (kg/m\^2).

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have been treated with drugs that promote weight loss within 3 months of the first study visit; have any self or family history of medullary c-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of men 2a or 2b syndrome).

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 Liraglutide and who got the comparison, which limits bias.

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

Being open-label, the Liraglutide study did not mask who received what.

It started in 2012-06 with completion listed for 2013-11.

It ran at 57 sites in United States (18), Poland (9), Germany (7), Spain (7), Hungary (4) and Romania (4).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 22 secondary outcomes, for example Change From Baseline in Body Weight at 26 Weeks, Change From Baseline in Body Mass Index (BMI) at 26 Weeks, Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks, Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks, Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and Number of Participants With Reported and Adjudicated Cardiovascular Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide and Dulaglutide in 599 people.

With 599 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 Liraglutide compound page and the Dulaglutide compound page, all human trials.