Trial Search Results

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke.

Eligible subjects must be randomized within 12 hours of stroke symptom onset and either have type 2 diabetes and glucose concentrations of over 110 mg/dL or no history of diabetes and glucose concentrations of 150 mg/dL or higher on initial evaluation. The enrolling sites will include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study will evaluate the safety and efficacy of targeted glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL. The primary outcome will be functional outcome at 3 months as measured by the modified Rankin Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as <40 mg/dL. Enrollment will occur over 5-7 years.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

University of Virginia

Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)

Intervention(s):

  • Drug: IV insulin to maintain target glucose concentration of 80-130 mg/dL
  • Drug: Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   1. Age 18 years or older

   2. Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring
   in one or more cerebral vascular territories. Neuroimaging must be done to exclude
   intracranial hemorrhage (ICH).

   3. Randomization must be within 12 hours after stroke symptom onset and treatment is
   recommended, but not required, to begin within 3 hours after hospital arrival. If time
   of symptom onset is unclear or patient is awakening with stroke symptoms, the time of
   onset will be the time the patient was last known to be normal.

   4. Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood
   glucose ≥150 mg/dL in those w/o known diabetes mellitus

   5. Baseline NIHSS score of 3-22

   6. Pre-stroke modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7.
   Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of
   8-22.

   7. Able to provide a valid informed consent to be in the study (self or their authorized
   legally accepted representative). The approved consent form must be signed and dated
   in accordance with federal and institutional guidelines.

Exclusion Criteria:

   1. Known history of type 1 diabetes mellitus

   2. Substantial pre-existing neurological or psychiatric illness that would confound the
   neurological assessment or other outcome assessment

   3. Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs)
   or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non
   FDA cleared devices are considered experimental and are excluded.

   4. Pregnant or breast-feeding at the time of study entry

   5. Other serious conditions that make the patient unlikely to survive 90 days

   6. Inability to follow the protocol or return for the 90 day follow up

   7. Renal dialysis (including hemo or peritoneal dialysis)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Rosen Mann
(650) 721-2645
Recruiting