REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study)

What Was Tested

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

It had two arms (groups): Control (no intervention) and Intervention (experimental).

Patients assigned to the control arm will receive usual care for AMI, according to local practice of each participating centre.

The registry classes the interventions as drug.

More on the Plan

Patients will be randomly assigned to either the control arm and will receive usual AMI care or the experimental arm, which will include routine AMI care as well as intensive therapy intervention.

Who Took Part

Enrollment: 500 planned participants were the target.

It was open to people of any sex.

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

Examples of who could join: Onset of symptoms within 24 hours before hospital presentation.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: patient with conditions that require the administration of insulin, including:; type 1 diabetes mellitus, defined by a documented history of diabetes mellitus before the age of 30; type 2 diabetes mellitus that was treated with insulin prior to ami presentation.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2008-04 with completion listed for 2010-06.

It ran at 13 sites in India (11), Argentina (1) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The 24-hour difference in mean glucose between the two study groups (time frame: 24 hours).

It also tracked 11 secondary outcomes, for example The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first), The difference in mean glucose level achieved at 30 days between study groups, Rehospitalization for congestive heart failure, All cause mortality, Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes) and Cardiogenic shock.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 500 people.

With 500 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.