Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control After Acute Stroke

What Was Tested

This registered phase 3 trial tested Insulin (regular human) and Insulin Glargine.

Hyperglycemia is common during acute ischemic stroke.

However, the optimal strategy to control hyperglycemia during acute ischemic stroke has not been established.

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

Subcutaneous long acting basal insulin (insulin glargine) with added short acting regular insulin to correct hyperglycemic events.

Short acting regular insulin pre-meal with added NPH at bed time if start eating.

The registry classes the interventions as drug.

More on the Plan

Study Rationale: Hyperglycemia is common during acute ischemic stroke.

Design: This is a 3-year, randomized, multicenter trial.

The exclusion criteria include patients with age \<20 years, pregnancy, shock, severe infection, end stage renal disease requiring dialysis, type I DM or current steroid usage.

The secondary endpoints include: (1) good functional outcome at 3 months post stroke (modified Rankin Scale \<2), (2) stroke in evolution, (3) 24 hours blood glucose variability via continuous glucose monitoring, and (4) blood and urine biomarkers.

Who Took Part

The registry lists 120 planned participants were the target.

It was open to people of any sex aged from 20 years with no upper age limit.

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

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: patients with age \<20 years,; shock, severe infection, end stage renal disease requiring dialysis,; type i dm or current steroid usage.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

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

It started in 2015-12 with completion listed for 2018-07.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The percentage of time in the range of [amount hidden]/dL during the sugar monitoring period.

It also tracked 5 secondary outcomes, for example Good functional outcome at 3 months post stroke, Stroke in evolution, Blood glucose variability via continuous glucose monitoring, Blood biomarkers and Urine biomarkers.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Insulin Glargine in 120 people.

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

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