Ischemic StrokePhase 1NCT02054429
Intensive Insulin Therapy With Tight Glycemic Control to Improve Outcomes After Endovascular Therapy for Acute Ischemic Stroke
A Phase 1 study testing Insulin in people with Ischemic Stroke, run by University at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of lowering glucose (blood sugar), in addition to endovascular therapy, after acute ischemic stroke. The study will determine if lowering glucose (blood sugar) in addition to endovascular therapy will improve 90-day functional and neurological outcomes… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 31 Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85 years
- All patients attending the emergency department (ED) of Kaleida health within 24 hrs of symptoms onset suggestive of an anterior circulation ischemic stroke.
- CT perfusion suggesting Ischemic Core less than 30% of Penumbra territory.
- No history of diabetes
- First neurological event
- Clinical signs consistent with the diagnosis of ischemic stroke, including impairment of language, motor function, cognition and/or gaze, vision, or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of a focal neurologic deficit presumed to be due to cerebral ischemia after exclusion of ICH with a baseline CT
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- The signal stroke should be (a) acute, (b) the most recent significant, acute worsening of serial neurologic events, or (c) related to a diagnostic radiographic procedure but not an interventional procedure
- Minimum NIHSS score >4, except for isolated aphasia or isolated hemianopsia
- Angiographic evidence of a clot in the anterior intracranial or extracranial circulation consistent with the neurologic deficit with complete occlusion (TICI grade 0) or contrast penetration with minimal perfusion (TICI grade 1).
- Signed informed consent to participate given by patient or legal representative.
Who cannot join
- Coma
- Neurologic signs that are rapidly improving by the time of randomization or treatment- a 4-point improvement from baseline NIHSS , or increase to absolute NIHSS > 30 before randomization or treatment
- Major stroke symptoms- NIHSS >30
- Seizure at the onset of stroke
- Stroke due to a neurointerventional procedure for treatment of a cerebral aneurysm and/or cerebral arteriovenous malformation (stroke due to diagnostic cerebral angiography or cardiac catheterization might be treated)
- Clinical presentation suggestive of subarachnoid hemorrhage, even when the initial CT scan is normal.
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- Previous known ICH at any time, neoplasm, and/or subarachnoid hemorrhage.
- Patients with a known arteriovenous malformation or aneurysm, with or without any evidence of associated hemorrhage.
- Presumed septic embolus
- Known hereditary or acquired hemorrhagic diathesis, eg, aPTT or prothrombin time greater than normal; unsupported coagulation factor deficiency.
- Baseline laboratory values that reveal platelets are <30 000/µL, hematocrit or platelet cell volume <25 volume %, or international normalized ratio >1.7. (Any patient receiving heparin at the onset of stroke symptoms must have an aPTT 2 times the upper limit of normal before randomization. Patients receiving low-molecular-weight heparin might need to be excluded because an anticoagulant effect is not measured by aPTT.)
- Pregnancy, lactation, or parturition within the previous 30 days.
- Known serious sensitivity to radiographic contrast agents.
- Other serious, advanced, or terminal illness such that life expectancy is <1 year.
- Current participation in another research treatment protocol.
- Previous participation in an acute stroke study.
- Any condition in which angiography is contraindicated.
- Uncompensated hypertension at study entry or hypertension requiring aggressive treatment to reduce blood pressure to non-hypertensive limits. Uncompensated hypertension is defined as systolic blood pressure >180 mm Hg or diastolic blood pressure 100 mm Hg on 3 repeated measures at least 10 minutes apart. Aggressive treatment is defined as the need for a continuous, parenteral antihypertensive, such as a nitroprusside drip, or the need to administer >3 doses of a parenteral antihypertensive, such as labetalol, hydralazine, nicardepine.
- Dependency on renal dialysis or known serum creatinine > 2.0mg/dl
- Serum glucose at admission <80mg/dl
- All known diabetic patients
- Random Admission glucose > 200mg/dl
- High-attenuation lesion on CT consistent with a hemorrhage of any degree in any location.
- Evidence of a significant mass effect with a midline shift due to a large infarct
- Acute hypodense parenchymal lesion on CT or effacement of the cerebral sulci in more than one third of the MCA territory or suspected stroke region
- Angiographic evidence of (a) Suspected carotid arterial dissection. (b) Arterial stenosis as the sole lesion or a high-grade stenosis that does not allow safe passage of a catheter. (b) Any nonatherosclerotic arteriopathy (eg, vasculitis)
- Mentally incompetent and wards of the state.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Buffalo Neurosurgery
Buffalo, New York, 14203
About this study
The purpose of this study is to determine the safety and efficacy of lowering glucose (blood sugar), in addition to endovascular therapy, after acute ischemic stroke. The study will determine if lowering glucose (blood sugar) in addition to endovascular therapy will improve 90-day functional and neurological outcomes in comparison to standard glycemic care in patients with acute ischemic stroke. The study will involve treatment of 100 (50 intensive insulin therapy and 50 standard glycemic control) non-diabetic patients presenting within 8 hours of acute ischemic stroke who have undergone endovascular therapy.
Read the detailed description
This will be a prospective open label study of 100 subjects who will be randomized to either an insulin aspart (study drug) infusion (intensive insulin therapy [IIT arm]) for 48hrs or to a control arm. All patients attending the emergency department (ED) of Kaleida health within 24 hrs of symptom onset suggestive of an anterior circulation ischemic stroke will be screened. If they meet the inclusion criteria and do not have any exclusion criteria, informed consent will be obtained and a blinded stratified block randomization process will be initiated.
In addition to receiving endovascular and standard medical therapy for AIS, subjects will be randomized to an intensive insulin treatment arm (IIT arm) or control arm. In the IIT arm subjects will receive an insulin aspart infusion at a minimal rate of 2 units/hr while maintaining blood glucose between 90-120mg/dl for 48 hrs. Glucose control in the control will be at the discretion of the treating provider.
Subjects will have the following study procedures done at different time points: A) assessment of neurological outcomes : modified Rankin scale (mRS) at 30 days and 90 days and NIH stroke scale (NIHSS) at baseline , 24 hrs, 72 hrs, 30 days and 90 days.
- MRI (Diffusion weighted imaging), 3-5 days and 90 days and C) various plasma and cellular endpoints will be measured in blood collected at baseline, 2, 4, 6, 24 , 48 and 72 hrs and at 30 days and 90 days.
The primary endpoint of the study is to detect a difference in the percentage of non diabetic subjects with mRS 0-2 at 90 days after an AIS treated with endovascular therapy, in the IIT and control arm.
- Conditions
- Ischemic Stroke
- Being tested
- Insulin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Also called insulin and, dextrose/ potassium
Intensive Insulin Therapy (IIT) will be given to you by two IV infusions. The insulin infusion will be started immediately after you are moved to the intensive care unit (ICU) after endovascular therapy and continued for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Insulin | Experimental | IIT arm subjects will receive an insulin aspart infusion at a minimal rate of 2 units/hr while maintaining blood glucose between 90-120mg/dl for 48 hrs Receives: Drug: Insulin |
| Standard glycemic control | No intervention | standard of care if not randomized to Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Scale
modified Rankin Score (specific aim) and NIH stroke scale (exploratory aim)
Measured: 90 days
Secondary outcomes (1)
MRI
Measure infarct volume and determine if there is a reduction in infact volume in the insulin-infused group
Measured: 2, 3, 5, and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJan 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan H. Siddiqui, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054429
- Sponsor's protocol ID
- INSULIN
- Status last verified
- Aug 2025
- First submitted
- 31 Jan 2014
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Insulin Therapy With Tight Glycemic Control to Improve Outcomes After Endovascular Therapy for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02054429
- Acronym / sponsor ID
- INSULIN
- Conditions
- Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 4 Feb 2014 (estimated)
- 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.
The purpose of this study is to determine the safety and efficacy of lowering glucose (blood sugar), in addition to endovascular therapy, after acute ischemic stroke. The study will determine if lowering glucose (blood sugar) in addition to endovascular therapy will improve 90-day functional and neurological outcomes in comparison to standard glycemic care in patients with acute ischemic stroke. The study will involve treatment of 100 (50 intensive insulin therapy and 50 standard glycemic control) non-diabetic patients presenting within 8 hours of acute ischemic stroke who have undergone endovascular therapy.
Detailed description
This will be a prospective open label study of 100 subjects who will be randomized to either an insulin aspart (study drug) infusion (intensive insulin therapy [IIT arm]) for 48hrs or to a control arm. All patients attending the emergency department (ED) of Kaleida health within 24 hrs of symptom onset suggestive of an anterior circulation ischemic stroke will be screened. If they meet the inclusion criteria and do not have any exclusion criteria, informed consent will be obtained and a blinded stratified block randomization process will be initiated.
In addition to receiving endovascular and standard medical therapy for AIS, subjects will be randomized to an intensive insulin treatment arm (IIT arm) or control arm. In the IIT arm subjects will receive an insulin aspart infusion at a minimal rate of 2 units/hr while maintaining blood glucose between 90-120mg/dl for 48 hrs. Glucose control in the control will be at the discretion of the treating provider.
Subjects will have the following study procedures done at different time points: A) assessment of neurological outcomes : modified Rankin scale (mRS) at 30 days and 90 days and NIH stroke scale (NIHSS) at baseline , 24 hrs, 72 hrs, 30 days and 90 days.
- MRI (Diffusion weighted imaging), 3-5 days and 90 days and C) various plasma and cellular endpoints will be measured in blood collected at baseline, 2, 4, 6, 24 , 48 and 72 hrs and at 30 days and 90 days.
The primary endpoint of the study is to detect a difference in the percentage of non diabetic subjects with mRS 0-2 at 90 days after an AIS treated with endovascular therapy, in the IIT and control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin | Experimental | Drug: InsulinIIT arm subjects will receive an insulin aspart infusion at a minimal rate of 2 units/hr while maintaining blood glucose between 90-120mg/dl for 48 hrs |
| Standard glycemic control | No intervention | –standard of care if not randomized to Insulin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-85 years
- All patients attending the emergency department (ED) of Kaleida health within 24 hrs of symptoms onset suggestive of an anterior circulation ischemic stroke.
- CT perfusion suggesting Ischemic Core less than 30% of Penumbra territory.
- No history of diabetes
- First neurological event
Key exclusion criteria (27 listed)
- Coma
- Neurologic signs that are rapidly improving by the time of randomization or treatment- a 4-point improvement from baseline NIHSS , or increase to absolute NIHSS > 30 before randomization or treatment
- Major stroke symptoms- NIHSS >30
- Seizure at the onset of stroke
- Stroke due to a neurointerventional procedure for treatment of a cerebral aneurysm and/or cerebral arteriovenous malformation (stroke due to diagnostic cerebral angiography or cardiac catheterization might be treated)
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 |
|---|---|---|
| InsulinAlso: insulin and, dextrose/ potassiumIntensive Insulin Therapy (IIT) will be given to you by two IV infusions. The insulin infusion will be started immediately after you are moved to the intensive care unit (ICU) after endovascular therapy and continued for 48 hours | Drug | Insulin |
Primary outcome
Stroke Scale
Time frame: 90 days
modified Rankin Score (specific aim) and NIH stroke scale (exploratory aim)
1 secondary outcome
MRI
Time frame: 2, 3, 5, and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin in people with Ischemic Stroke, run by University at Buffalo at 1 site in United States.
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 10 inclusion and 27 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: finished, as of the sponsor's last update on 8 Aug 2025. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Scale (time frame: 90 days). 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 8 Aug 2025.