Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

The aim of their study was to assess the short-term effects and the safety of strict glycemic control in subjects with AMI and hyperglycemia without a previous history of diabetes.

It had 1 arm (groups): Serum saline (sham comparator).

The registry classes the interventions as drug.

More on the Plan

High-sensitivity C-reactive protein (HS-CRP) was determined at 48 hours and before discharge and an oral glucose tolerance test (OGTT) was performed at 1 month.

Who Took Part

28 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: Confirmed diagnosis of AMI, either with or without ST segment elevation. Presence of high blood glucose at admission with no previously known diabetes mellitus (DM).

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: age under 18 years old; history of dm; presence of other cardiopathies (dilated cardiomyopathy, valvular or hypertrophic heart disease).

How the Study Was Run

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

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

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2006-01 with completion listed for 2006-12.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glycemic control (time frame: first 48 hours).

It also tracked 1 secondary outcome, for example High-sensitivity C-reactive protein levels.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 28 people.

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

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

More context: the Insulin (regular human) compound page, all human trials.