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

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Dulaglutide.

Participants must also be taking metformin and glimepiride.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 810 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 not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea). Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications. Accept treatment with metformin and glimepiride throughout the study, as per protocol. Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.

The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: type 1 diabetes; hba1c equal to or less than 6.5 at randomization; chronic insulin use.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2010-02 with completion listed for 2012-05.

It ran at 78 sites in Canada (8), India (7), Poland (6), Taiwan (6), Australia (5) and France (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, 52 weeks).

It also tracked 25 secondary outcomes, for example Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c), Change From Baseline to 52 and 78 Weeks in Glucagon Concentration, Change From Baseline to 26, 52 and 78 Weeks for Body Weight, Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index, Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension and Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Dulaglutide in 810 people.

With 810 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 Insulin Glargine compound page and the Dulaglutide compound page, all human trials.