Insulin for Hyperglycemia in Stroke Trial

What Was Tested

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

Introduction: Glycemic control in acutely ill stroke patients with hyperglycemia is vital.

It had two arms (groups): Analog insulin arm (experimental) and Human insulin arm (active comparator).

The registry classes the interventions as drug.

More on the Plan

All oral antidiabetic drugs will be discontinued on admission.

BG will be measured before each bolus insulin injection (at 6 am, 12 pm and 6 pm).

Except anti-diabetic treatment, other treatments will be continued as per the decisions of the treating physicians.

Modern insulin group will receive neutralizing insulin with any dextrose containing fluid with glargine insulin as before.

Who Took Part

Enrollment: 452 actual participants took part.

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: • Patients admitted to adult neurology ward with acute stroke with. Patients with age of 18-80 years of both sexes. Patients or their attendants giving consent to take part in the study.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: patients with hyperglycemic emergencies (hyperglycemic hyperosmolar state or diabetic ketoacidosis); pregnant patients; those not giving consent to participate in the study.

How the Study Was Run

The set-up was 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.

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 2021-04-05 with completion listed for 2021-06-20.

It ran at 1 site in Bangladesh.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glycemic Control (time frame: During the hospital stay assessed up to 10 days).

It also tracked 3 secondary outcomes, for example Mortality.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 452 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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