Delayed vs Early Antihyperglycemic Treatment for Severe Stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, randomized, open-label trial with blinded endpoints enrolling adults with severe stroke and hyperglycemia within 24 hours of onset. Participants are assigned 1:1 to delayed versus early antihyperglycemic treatment using intravenous insulin, with glycemic targets of 7.8–10.0 mmol/L guided by standard practices. The primary outcome is poor functional outcome (modified Rankin Scale ≥3) at 90 days, with secondary outcomes including mortality, neurological scores, ICU stay, and safety events. The study aims to determine if delaying insulin initiation can influence neurological recovery compared with early initiation. Enrollment targets a total of 426 patients across specified severe stroke etiologies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

1）Severe ischemic stroke: Glasgow Coma Scale (GCS) score ≤ 12 or National Institutes of Health Stroke Scale (NIHSS) score ≥ 15 or CT hypodensity \> 1/3 of middle cerebral artery (MCA) territory; 2）Severe intracerebral hemorrhage: Supratentorial hematoma volume ≥ 30 mL (thalamic hemorrhage ≥ 10 mL) or infratentorial hematoma volume ≥ 10 mL (brainstem hemorrhage ≥ 5 mL); 3）Aneurysmal subarachnoid hemorrhage; 3. Blood glucose level \> 10 mmol/L at randomization; 4. Signed informed consent.

Exclusion Criteria:

1. Known history of type 1 diabetes mellitus;
2. Known allergy to insulin or diagnosis of insulinoma;
3. Pre-stroke modified Rankin Scale (mRS) score \> 1;
4. Hemodynamic instability refractory to medical treatment (systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg);
5. Decompensated heart failure (New York Heart Association \[NYHA\] class III or IV);
6. Estimated glomerular filtration rate (eGFR) \< 30 mL/min;
7. Expected survival \< 90 days due to malignancy;
8. Participation in another drug or device clinical trial within the past 30 days;
9. Women of childbearing potential who refuse to use effective contraception despite negative pregnancy test, pregnant women, or breastfeeding women.

Where it's running

• The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)
  Wuhu, Anhui, China Recruiting

Study contacts

• Study coordinator: Yu Zhang Yu, Master of Medicine
• Email: zy173340@163.com
• Phone: +86 18325328672

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.