Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Coronary Artery Bypass Graft (CABG) Patients

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

Most coronary artery bypass graft surgery (CABG) patients develop high blood sugar while they are in the hospital.

Patients with high blood sugar and diabetes after cardiac bypass surgery will be followed for 3 months to look at how well their treatment(s) for diabetes work after discharge.

It had seven arms (groups): one (no intervention), one (active comparator), one (active comparator), No diabetes/ Metformin only (active comparator) and Diabetic/antidiabetic regimen (active comparator).

The registry classes the interventions as drug.

More on the Plan

No prospective studies have examined the impact of a discharge treatment regimen after cardiac surgery.

The total duration of the study is 3 months.

A patient without a history of diabetes who requires SC insulin is likely a newly diagnosed diabetic.

The HbA1c value will be important to confirm the diagnosis.

Who Took Part

175 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Males or females between the ages of 18 and 80 years undergoing primary coronary artery bypass graft surgery (CABG). Patients with and without a history of type 2 diabetes.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: subjects with acute hyperglycemic crises such as diabetic ketoacidosis (dka) and hyperosmolar hyperglycemic states; patients or next-to-kin with mental conditions rendering the subject or family member unable to understand the nature, scope, and possible consequences of the study; female subjects who are pregnant or breast-feeding at time of enrollment into the study.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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 2012-10 with completion listed for 2014-02.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Number of Participants Readmitted to the Hospital, The Number of Participants Experiencing a Hypoglycemic Event, The Number of Participants Experiencing a Severe Hypoglycemic Event and Number of Participants Experiencing a Hyperglycemic Event.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Insulin Glargine in 175 people.

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, all human trials.