Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial (SHINE)
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.
|Acute Ischemic Stroke Diabetes Hyperglycemia||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 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial|
- modified Rankin Scale Score [ Time Frame: 3 months ]a 3 month (post stroke) modified Rankin scale score is the primary efficacy outcome measure.
- Hypoglycemia [ Time Frame: 72 hours ]Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Experimental: IV insulin drip with target glucose 80 mg/dL - 130 mg/dL
The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range.
Drug: IV insulin to maintain target glucose concentration of 80-130 mg/dL
Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.
Active Comparator: Sub Q insulin to keep glucose less than 180 mg/dL
This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL
Drug: Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL
Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369069
|Contact: Karen C Johnston, MD, MScfirstname.lastname@example.org|
|Contact: Heather M Haughey, PhDemail@example.com|
Show 62 Study Locations
|Study Chair:||Karen C Johnston, MD, MSc||University of Virginia|
|Principal Investigator:||Christiana Hall, MD, MS||UT Southwestern|
|Principal Investigator:||Askiel Bruno, MD, MS||Augusta University|
|Principal Investigator:||Valerie Durkalski, PhD||Medical University of South Carolina|
|Principal Investigator:||William Barsan, MD||University of Michigan|
|Principal Investigator:||Kevin Barrett, MD||Mayo Clinic|