Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)

What Was Tested

This registered phase 3 trial tested Dulaglutide.

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

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: Type 2 diabetes mellitus. Accept continued treatment with sulfonylurea therapy, throughout the trial, as required per protocol. Men and nonpregnant women aged ≥18 years. Body Mass Index (BMI) ≤45 kilograms per 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 prior to the first study visit; are receiving chronic (\>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Dulaglutide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2013-01 with completion listed for 2014-12.

It ran at 31 sites in United States (6), Croatia (6), Romania (6), Argentina (4), South Africa (3) and Austria (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks (time frame: Baseline, 24 Weeks).

It also tracked 15 secondary outcomes, for example Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks, Change From Baseline in Body Weight at 24 Weeks, Change From Baseline in Body Mass Index (BMI) at 24 Weeks, Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks, Number of Participants With Reported and Adjudicated Cardiovascular Events and Number of Participants With Adjudicated Acute Pancreatitis Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of 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 Dulaglutide compound page, all human trials.