Severe StrokePhase 2NCT07501533
Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke
A Phase 2 study testing Intravenous insulin in people with Severe Stroke, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Stroke
- What is being tested?
- Intravenous insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2026to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known history of type 1 diabetes mellitus;
- Known allergy to insulin or diagnosis of insulinoma;
- Pre-stroke modified Rankin Scale (mRS) score > 1;
- Hemodynamic instability refractory to medical treatment (systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg);
- Decompensated heart failure (New York Heart Association [NYHA] class III or IV);
- Estimated glomerular filtration rate (eGFR) < 30 mL/min;
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- Expected survival < 90 days due to malignancy;
- Participation in another drug or device clinical trial within the past 30 days;
- Women of childbearing potential who refuse to use effective contraception despite negative pregnancy test, pregnant women, or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)
Wuhu, Anhui, 241001
Yu Zhang Yu, Master of Medicine, +86 18325328672, zy173340@163.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Severe Stroke
- Being tested
- Intravenous insulin
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous insulinDrug
Insulin administered intravenously to maintain blood glucose between 7.8-10.0 mmol/L. Timing of initiation differs by arm: Day 1 for early group, Day 4 for delayed group.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Antihyperglycemic Group | Experimental | Antihyperglycemic treatment is delayed for 72 hours after enrollment. Insulin therapy is initiated on Day 4 targeting blood glucose 7.8-10.0 mmol/L until ICU discharge or Day 14. Receives: Drug: Intravenous insulin |
| Early Antihyperglycemic Group | Active comparator | Antihyperglycemic treatment is initiated on Day 1. Insulin therapy targets blood glucose 7.8-10.0 mmol/L until ICU discharge or Day 14. Receives: Drug: Intravenous insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor Functional Outcome at 90 Days
Proportion of patients with modified Rankin Scale (mRS) score ≥ 3, assessed at 90 days post-randomization. The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (death).
Measured: from enrollment to day 90 post-enrollment
Secondary outcomes (7)
All-cause Mortality at ICU Discharge or Day 14
Proportion of patients who die from any cause by ICU discharge or Day 14, whichever occurs first
Measured: from admission to ICU discharge within 14 days
Neurological Status at ICU Discharge or Day 14
Neurological function assessed by National Institutes of Health Stroke Scale (NIHSS) score. NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological deficits
Measured: from admission to ICU discharge within 14 days
Level of Consciousness at ICU Discharge or Day 14
Level of consciousness assessed by Glasgow Coma Scale (GCS) score. GCS ranges from 3 to 15, with lower scores indicating impaired consciousness
Measured: from admission to ICU discharge within 14 days
All-cause Mortality at 90 Days
Proportion of patients who die from any cause within 90 days post-randomization
Measured: from admission to discharge at 90 days
Length of ICU Stay
Total duration of intensive care unit (ICU) hospitalization, measured in days
Measured: From admission to ICU discharge, an average of 11 days
Incidence of Adverse Events
Proportion of patients experiencing adverse events during ICU stay, including hypoglycemia (random blood glucose < 3.3 mmol/L), symptomatic hypoglycemia, pulmonary infection, urinary tract infection, and electrolyte disturbances
Measured: From randomization to ICU discharge or Day 14, whichever occurs first
Incidence of Serious Adverse Events
Proportion of patients experiencing serious adverse events, defined as any event resulting in death, disability, congenital anomaly, or severe hypoglycemia (random blood glucose < 2.22 mmol/L) requiring prolonged hospitalization or re-admission
Measured: From randomization to 90 day post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start18 Jun 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501533
- Sponsor's protocol ID
- 202603
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke: A Prospective, Randomized, Controlled, Open-Label, Blinded-Endpoint Clinical Trial
- ClinicalTrials.gov ID
- NCT07501533
- Acronym / sponsor ID
- 202603
- Conditions
- Severe Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Antihyperglycemic Group | Experimental | Drug: Intravenous insulinAntihyperglycemic treatment is delayed for 72 hours after enrollment. Insulin therapy is initiated on Day 4 targeting blood glucose 7.8-10.0 mmol/L until ICU discharge or Day 14. |
| Early Antihyperglycemic Group | Active comparator | Drug: Intravenous insulinAntihyperglycemic treatment is initiated on Day 1. Insulin therapy targets blood glucose 7.8-10.0 mmol/L until ICU discharge or Day 14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- Known history of type 1 diabetes mellitus;
- Known allergy to insulin or diagnosis of insulinoma;
- Pre-stroke modified Rankin Scale (mRS) score > 1;
- Hemodynamic instability refractory to medical treatment (systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg);
- Decompensated heart failure (New York Heart Association [NYHA] class III or IV);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous insulinInsulin administered intravenously to maintain blood glucose between 7.8-10.0 mmol/L. Timing of initiation differs by arm: Day 1 for early group, Day 4 for delayed group. | Drug | Delayed Antihyperglycemic Group, Early Antihyperglycemic Group |
Primary outcome
Poor Functional Outcome at 90 Days
Time frame: from enrollment to day 90 post-enrollment
Proportion of patients with modified Rankin Scale (mRS) score ≥ 3, assessed at 90 days post-randomization. The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (death).
7 secondary outcomes
All-cause Mortality at ICU Discharge or Day 14
Time frame: from admission to ICU discharge within 14 days
Neurological Status at ICU Discharge or Day 14
Time frame: from admission to ICU discharge within 14 days
Level of Consciousness at ICU Discharge or Day 14
Time frame: from admission to ICU discharge within 14 days
All-cause Mortality at 90 Days
Time frame: from admission to discharge at 90 days
Length of ICU Stay
Time frame: From admission to ICU discharge, an average of 11 days
Incidence of Adverse Events
Time frame: From randomization to ICU discharge or Day 14, whichever occurs first
Incidence of Serious Adverse Events
Time frame: From randomization to 90 day post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous insulin in people with Severe Stroke, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Zhang Yu, Master of Medicine (+86 18325328672, zy173340@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor Functional Outcome at 90 Days (time frame: from enrollment to day 90 post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.