A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)

What Was Tested

This registered phase 3 trial tested Dulaglutide.

It had three arms (groups): one (experimental), one (experimental) and Metformin (active comparator).

The registry classes the interventions as drug.

More on the Plan

The term rescue therapy in this trial was defined primarily as additional nontrial antidiabetic medication for the management of severe, persistent hyperglycemia or alternative antidiabetic medication following study drug discontinuation.

For safety analyses, with the exception of hypoglycemia outcomes, all measurements including those obtained after taking rescue therapy were included in the analysis.

Who Took Part

Enrollment: 807 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 a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2), inclusive. Are well-motivated, capable, and willing to: a) perform self-monitored blood glucose (SMBG) testing; b) learn how to self-inject treatment (LY2189265 or placebo) and c) maintain a study diary.

The full record lists 8 inclusion and 17 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have had 1 or more cases of uncontrolled diabetes that required hospitalization in the 6 months prior to screening; have a problem with the liver or pancreas.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Dulaglutide and who got the comparison, which limits bias.

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

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

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

It started in 2010-05 with completion listed for 2011-11.

It ran at 91 sites in United States (28), Canada (6), United Kingdom (6), Germany (5), Croatia (4) and France (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, 26 weeks).

It also tracked 29 secondary outcomes, for example Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c), Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose, Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles, Change From Baseline to 26 and 52 Weeks in Body Weight, Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI) and Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Dulaglutide in 807 people.

With 807 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.