Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

What Was Tested

The trial (phase 3) is built around Dulaglutide.

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

Administered once weekly, subcutaneously.

Administered once weekly, subcutaneously.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 9901 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone. On stable antihyperglycemic regimen for at least 3 months.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: uncontrolled diabetes requiring immediate therapy; history of severe hypoglycemia in past year; acute coronary or cerebrovascular event within past 2 months.

How the Study Was Run

Design: randomized, parallel-group and double-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.

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 and investigator.

It started in 2011-07-22 with completion listed for 2018-08-21.

It ran at 300 sites in United States (51), Canada (28), Argentina (21), Germany (19), Romania (17) and South Africa (15).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Number of Participants Who Experienced an Event for Time to All-cause Mortality and Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Dulaglutide in 9901 people.

With 9901 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.