Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke

NCT07501533 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 202603
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Severe Stroke

Outcome Measures

Primary Outcomes (1)

• 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).

  from enrollment to day 90 post-enrollment

Secondary Outcomes (7)

• All-cause Mortality at ICU Discharge or Day 14

  from admission to ICU discharge within 14 days

• Neurological Status at ICU Discharge or Day 14

  from admission to ICU discharge within 14 days

• Level of Consciousness at ICU Discharge or Day 14

  from admission to ICU discharge within 14 days

• All-cause Mortality at 90 Days

  from admission to discharge at 90 days

• Length of ICU Stay

  From admission to ICU discharge, an average of 11 days

Study Arms (2)

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.

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.

Drug: Intravenous insulin

Interventions

Intravenous insulin DRUG

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.

Delayed Antihyperglycemic Group; Early Antihyperglycemic Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share