NCT07501533RecruitingPhase 2
Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke
Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke: A Prospective, Randomized, Controlled, Open-Label, Blinded-Endpoint Clinical Trial
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 4 Mar 2026
- Start date
- 18 Jun 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Diseases
- Stroke
- NCT number
- NCT07501533
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 18 Jun 2026 to the primary completion date, 31 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another drug or device clinical trial within the past 30 days;
Other illness
- 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;
Lab values
- Estimated glomerular filtration rate (eGFR) \< 30 mL/min;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital) Coordinator of this site? Confirm its status | Wuhu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.