Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

It had two arms (groups): Insulin (active comparator) and Regular Insulin (other).

Intensive Insulin Therapy.

Sub Cutaneous Regular Insulin.

The registry classes the interventions as drug.

More on the Plan

The proposed study is a one center open-label randomized controlled clinical trial.Coronary Intensive Care of one hospital in the city of Curitiba, PR, Brazil will be assessed.

Consenting eligible subjects will be randomized to either the intensive insulin infusion therapy group (ITG) or the conventional therapy group (CTG).

The control group will be selected following the same set of inclusion and exclusion criteria.

Patients will be randomized to receive SC regular insulin 4 times daily (before meals and bedtime) or every 6 hours if they are NPO .

Who Took Part

130 planned participants were the target.

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: Male or female. Age 18 or older. Evidence of Unstable Angina. Willing to give informed consent. Access to telephone communications after hospital discharge.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: under 18 years of age; pregnant or lactating female; diabetes ketoacidosis.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2012-08 with completion listed for 2013-08.

It ran at 2 sites in United States (1) and Brazil (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Differences in daily blood glucose mean concentration between treatment groups (time frame: 18 months).

It also tracked 1 secondary outcome, for example Evaluating the performance of the insulin drip protocol to maintain target glucose control(TGC).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 130 people.

Its status is suspended; no results are posted to the registry yet, so nothing here describes outcomes.

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