Comparing Early and Delayed Insulin Treatment for High Blood Sugar After Severe Stroke
Compares starting insulin early or after 72 hours in adults with severe stroke.
Plain-language title generated from the registry record
Registry title: Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke
Key facts
- Where
- Wuhu, ChinaSee the site
- Phase
- Phase 2
Where in China
- The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)Wuhu, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First Affiliated Hospital of Wannan Medical College
- Trial code
- NCT07501533
- Record updated
- 4 September 2026
- Original description
This study is a exploratory, randomized, controlled, open-label, blinded-endpoint Phase II clinical trial designed to evaluate whether delaying antihyperglycemic treatment for 72 hours improves neurological outcomes in patients with severe stroke and hyperglycemia.Read full original descriptionShow less
Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke: A Prospective, Randomized, Controlled, Open-Label, Blinded-Endpoint Clinical Trial
This study is a exploratory, randomized, controlled, open-label, blinded-endpoint Phase II clinical trial designed to evaluate whether delaying antihyperglycemic treatment for 72 hours improves neurological outcomes in patients with severe stroke and hyperglycemia.
A total of 426 patients with severe stroke (including ischemic stroke, intracerebral hemorrhage, or aneurysmal subarachnoid hemorrhage) within 24 hours of onset and blood glucose >10 mmol/L at randomization will be enrolled. 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). Glycemic control targets (7.8-10.0 mmol/L) and insulin therapy follow current clinical guidelines.
The primary outcome is the incidence of poor functional outcome (modified Rankin Scale score ≥ 3) at 90 days. Secondary outcomes include mortality, NIHSS score, GCS score, ICU length of stay, and safety events such as hypoglycemia and infections.
The study aims to provide evidence on the optimal timing of glycemic control in severe stroke patients with stress hyperglycemia.
Inclusion: Age ≥ 18 years; 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: Participation in another drug or device clinical trial within the past 30 days; Known history of type 1 diabetes mellitus; Known allergy to insulin or diagnosis of insulinoma; Pre-stroke modified Rankin Scale (mRS) score > 1; Decompensated heart failure (New York Heart Association [NYHA] class III or IV); Expected survival < 90 days due to malignancy; Estimated glomerular filtration rate (eGFR) < 30 mL/min; Hemodynamic instability refractory to medical treatment (systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg); Women of childbearing potential who refuse to use effective contraception despite negative pregnancy test, pregnant women, or breastfeeding women.