CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,151 enrolled
Drug / intervention
IV insulin to maintain target glucose concentration of 80-130 mg/dL +1 moredrug
Likely dose
IV insulin to maintain target glucose concentration of 80-130 mg/dLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01369069
NCT01369069Phase 3Completed
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Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

University of Virginia·interventional·Posted Jun 8, 2011·Updated Dec 23, 2019

In Brief

A Phase 3 clinical trial evaluating IV insulin to maintain target glucose concentration of 80-130 mg/dL and Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL for Acute Ischemic Stroke and 2 related conditions. Completed, enrolled 1,151 participants across 70 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Ischemic Stroke, Diabetes, Hyperglycemia
CountriesUnited States
CollaboratorsNeurological Emergencies Treatment Trials Network (NETT), Medical University of South Carolina, National Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2011
Enrollment StartApr 1, 2012
Primary CompletionNov 19, 2018
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 15.1 years ago

Interventions

IV insulin to maintain target glucose concentration of 80-130 mg/dLdrug

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.

Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dLdrug

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.