SHINE

Clinical Trial Details

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

The goal of SHINE was to investigate whether 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.

Key Findings

90-day functional stroke outcomes were not improved with IV insulin therapy for hyperglycemia in AIS patients compared to standard insulin injections.

Purpose: evaluation of the safety and efficacy of IV insulin compared to standard insulin therapy to control hyperglycemia in AIS patients.

Trial Design: Phase lll, randomized, controlled trial; double-blinded outcomes; 70 US sites (includes Neurological Emergencies Treatment Trials (NETT) sites and StrokeNet sites); n=1151; hyperglycemic AIS patients (80% with T2DM) enrolled w/in 12 hrs. of stroke symptom onset. 4 interim analyses. Continuous IV insulin infusion up to 72 hours after stroke symptom onset with a target of 80 - 130 mg/dL. Standard therpay: subcutaneous insulin every 6 hours; target <180 mg/dL.

Primary Endpoints: Efficacy - 90-day modified Rankin Scale (mRS); Safety of intensive glucose control - < 4% increase severe hypoglycemia (<40 mg/dL) up to 72 hours compared to standard therapy.

SHINE Primary Results
EfficacyIV insulin
(intensive)
SQ insulin
(standard)
 
90-day mRS.119 patients
20.5%
123 patients
21.6%
P= 0.55
Severe hypoglycemia15 patients
2.6%
0 patientsRisk Difference
2.58%

Results: 90-day functional stroke outcomes were not improved with intensive IV insulin for hyperglycemia control in AIS compared to standard sq sliding scale insulin injections. Severe hypoglycemia risk was increased with the intensive approach.

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SHINE Results

Louise McCullough, MD, vice chair for ISC 2019, interviews Karen Johnston, MD, principal investigator of the SHINE trial about the results and their significance for patients and clinicians.

Detailed Results

Detailed Results

Primary endpoints:

Efficacy:
  • mRS with Intensive IV glucose control: 119 patients, 20.5%
  • mRS with SQ insulin (standard): 123 patients, 21.6%
  • p=0.55

Other Endpoints: The risk for severe hypoglycemia was increased with intensive IV glucose control compared to standard SQ insulin.

Severe hypoglycemia
  • Intensive IV insulin – 15 patients, 2.6%
  • Standard SQ insulin – 0 patients

Background

Trial Design

  • Phase III, randomized, controlled trial; double-blinded outcomes;
  • 70 US sites (includes Neurological Emergencies Treatment Trials (NETT) sites and StrokeNet sites);
  • n=1151;
  • Hyperglycemic AIS patients enrolled w/in 12 hrs. of stroke symptom onset. 4 interim analyses.
  • Intensive glucose control: continuous IV insulin infusion up to 72 hours after stroke symptom onset; target of 80 - 130 mg/dL.
  • Standard therpay: subcutaneous insulin every 6 hours; target <180 mg/dL.

Primary Endpoints

  • Efficacy: 90-day modified Rankin Scale (mRS); Safety of intensive glucose control - < 4% increase severe hypoglycemia (<40 mg/dL) up to 72 hours compared to standard therapy

Sponsor— University of Virginia, Neurological Emergencies Treatment Trials Network (NETT), Medical University of South Carolina, National Institute of Neurological Disorders and Stroke (NINDS)

References

Key Words
stroke, diabetes, hyperglycemia

Related Clinical Topics
Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Globin Zinc Insulin, Insulin, Benzocaine, Hypoglycemic Agents, Physiological Effects of Drugs, Anesthetics, Local Anesthetics, Central Nervous System Depressants, Sensory System Agents, Peripheral Nervous System Agents

See more Science News from ISC 2019