Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial "SHINE"

Recruiting

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • IV insulin to maintain target glucose concentration of 80-130 mg/dL Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: IV insulin drip with target glucose 80 mg/dL - 130 mg/dL
    Description: 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.
  • Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Sub Q insulin to keep glucose less than 180 mg/dL
    Description: This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary modified Rankin Scale Score 3 months No
Primary Hypoglycemia 72 hours Yes

Sponsors