Efficacy and Safety of Continuous Intravenous Versus Usual Subcutaneous Insulin in Acute Ischemic Stroke

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Insulin (regular human).

But the modalities of glucose lowering are still debated.

It had 1 arm (groups): 2 (experimental).

Insulin.

The registry classes the interventions as drug.

More on the Plan

Yet, the efficiency of aggressive insulin serum glucose control is not established.

Furthermore the modalities of insulin administration are discussed since US and European guidelines recommend subcutaneous administration, whereas some groups use intravenous administration of insulin.

The study will include carotid territory stroke at the acute stage (\< 6 hours of onset) confirmed by MRI, and randomized in intravenous versus subcutaneous insulin.

Who Took Part

Enrollment: 180 actual participants took part.

It was open to people of any sex aged from 19 years with no upper age limit.

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

Examples of who could join: Age over 18 years. Carotid territory stroke. MRI performed in the first five hours of stroke onset. Baseline National Institutes of Health Stroke Scale (NIHSS) \> 4 or \< 26. Time between MRI and treatment under one hour.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: pre-existing modified rankin scale of three or higher.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

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

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

It started in 2007-05 with completion listed for 2012-06.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of patients in the glucose target range within 24 hours of the initiation of treatment (time frame: 24 hours).

It also tracked 3 secondary outcomes, for example Modified Rankin Scale at three months and Magnetic resonance imaging (MRI) infarct growth at one day.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Insulin (regular human) in 180 people.

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.