Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

It had two arms (groups): Intensive Insulin Therapy (IIT) (active comparator) and Standard Glycemic Care (SGC) (active comparator).

In SGC arm subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 34 actual participants took part.

It was open to people of any sex aged from 35 years up to 80 years.

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

Examples of who could join: No history of illicit drug abuse in past year. A minimum of 30 minutes but \< or = 6 hours of continuous pain/symptoms immediately prior to presentation. Subjects who will undergo primary percutaneous coronary intervention (PCI). Signed informed consent and HIPAA documentation (US only) prior to participation in the study. Subjects ability and willingness to adhere to and be compliant with study protocol.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: A prior history of Myocardial Infarction (MI); subjects who have received any thrombolytic therapy during the current hospital admission; severe heart failure or cardiogenic shock (killip class 3 or 4) by history or present at the time of screening.

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.

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

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2008-04 with completion listed for 2009-11.

It ran at 5 sites in United States (1), Argentina (1), Brazil (1), Canada (1) and Mexico (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Infarct Size Absolute Change From Baseline at Day 60 (time frame: From baseline at Day 60).

It also tracked 3 secondary outcomes, for example Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI), Occurrence of the Major Adverse Cardiovascular Events (MACE) and Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 34 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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