Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke

What Was Tested

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

Participants will be randomly assigned in a 1:1 ratio to either delayed antihyperglycemic treatment (initiated on Day 4) or early antihyperglycemic treatment (initiated on Day 1).

It had two arms (groups): Delayed Antihyperglycemic Group (experimental) and Early Antihyperglycemic Group (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 200 planned participants were the target.

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: Age ≥ 18 years;. Severe stroke within 24 hours of onset, meeting one of the following criteria:.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: known history of type 1 diabetes mellitus;; known allergy to insulin or diagnosis of insulinoma;; pre-stroke modified rankin scale (mrs) score \> 1;.

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 2026-06-18 with completion listed for 2028-03-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Poor Functional Outcome at 90 Days (time frame: from enrollment to day 90 post-enrollment).

It also tracked 7 secondary outcomes, for example All-cause Mortality at ICU Discharge or Day 14, Neurological Status at ICU Discharge or Day 14, Level of Consciousness at ICU Discharge or Day 14, All-cause Mortality at 90 Days, Length of ICU Stay and Incidence of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 200 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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