Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

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)