NCT01369069

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,151 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study evaluates 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.

Conditions

• Acute Ischemic Stroke
• Diabetes
• Hyperglycemia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2012-04-01
• Primary completion: 2018-11-19
• Completion: 2018-11-19
• First posted: 2011-06-08
• Last updated: 2019-12-23
• Results posted: 2019-12-16

Locations

70 sites across 1 country: United States