Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital
  • Parkland Health & Hospital System

Katrina Van De Bruinhorst

Principal Investigator
Christiana Hall, M.D.

Official Title

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

Brief Overview

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 within 12 hours of stroke symptom onset and have diabetes and
glucose concentrations of over 110 mg/dL 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 3.5 - 4 years.

Participant 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. Protocol treatment must begin within 12 hours after stroke symptom onset and 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

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)