Intensive Insulin Therapy With Tight Glycemic Control to Improve Outcomes After Endovascular Therapy for Acute Ischemic Stroke

What Was Tested

The trial (phase 1) is built around Insulin (regular human).

The study will involve treatment of 100 (50 intensive insulin therapy and 50 standard glycemic control) non-diabetic patients presenting within 8 hours of acute ischemic stroke who have undergone endovascular therapy.

It had two arms (groups): Insulin (experimental) and Standard glycemic control (no intervention).

Standard of care if not randomized to Insulin.

The registry classes the interventions as drug.

More on the Plan

This will be a prospective open label study of 100 subjects who will be randomized to either an insulin aspart (study drug) infusion (intensive insulin therapy \[IIT arm\]) for 48hrs or to a control arm.

If they meet the inclusion criteria and do not have any exclusion criteria, informed consent will be obtained and a blinded stratified block randomization process will be initiated.

In addition to receiving endovascular and standard medical therapy for AIS, subjects will be randomized to an intensive insulin treatment arm (IIT arm) or control arm.

Glucose control in the control will be at the discretion of the treating provider.

Who Took Part

The registry lists 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Age 18-85 years. No history of diabetes. First neurological event. Minimum NIHSS score \>4, except for isolated aphasia or isolated hemianopsia. Signed informed consent to participate given by patient or legal representative.

The full record lists 10 inclusion and 27 exclusion criteria; among the exclusions: major stroke symptoms- nihss \>30; seizure at the onset of stroke; previous known ich at any time, neoplasm, and/or subarachnoid hemorrhage.

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.

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

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

It started in 2013-01 with completion listed for 2016-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Stroke Scale (time frame: 90 days).

It also tracked 1 secondary outcome, for example MRI.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 30 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.