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Insulin

IV insulin drip with target glucose 80 mg/dL - 130 mg/dL for High Blood Sugar (SHINE Trial)

Phase 3
Waitlist Available
Led By Valerie Durkalski, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days (+30 days)
Awards & highlights

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.

Eligible Conditions
  • Diabetes
  • High Blood Sugar
  • Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days (-14/+30 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days (-14/+30 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)
Number of Participants With a Favorable Modified Rankin Scale (Yes/No)
Secondary outcome measures
Number of Participants With a Favorable Barthel Index
Number of Participants With a Favorable NIHSS
Stroke Specific Quality of Life (SSQOL)
Other outcome measures
Death

Side effects data

From 2018 Phase 3 trial • 1151 Patients • NCT01369069
54%
Hypoglycaemia
6%
Haemorrhagic transformation stroke
3%
Respiratory failure
3%
Ischaemic stroke
3%
Pneumonia
2%
Urinary tract infection
2%
Stroke in evolution
2%
Brain oedema
2%
Atrial fibrillation
2%
Hypokalaemia
2%
Headache
2%
Neurological decompensation
2%
Cerebrovascular accident
1%
Contusion
1%
Bradycardia
1%
Other (combined AEs happened only once)
1%
Pyrexia
1%
Cardiac arrest
1%
Cardiac failure
1%
Cardiac failure congestive
1%
Haemorrhage intracranial
1%
Renal failure acute
1%
Pulmonary embolism
1%
Pain in extremity
1%
Haemorrhage
1%
Transient ischaemic attack
1%
Hypertension
1%
Hypotension
1%
Acute myocardial infarction
1%
Myocardial infarction
1%
Cerebral haemorrhage
1%
Embolic stroke
1%
Aspiration
1%
Dyspnoea
1%
Pneumonia aspiration
1%
Leukocytosis
1%
Nausea
1%
Vomiting
1%
Urinary retention
1%
Sepsis
1%
Convulsion
1%
Deep vein thrombosis
1%
Blood chloride increased
1%
White blood cell count increased
1%
Hypocalcaemia
1%
Hypomagnesaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL
Sub Q Insulin to Keep Glucose Less Than 180 mg/dL

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IV insulin drip with target glucose 80 mg/dL - 130 mg/dLExperimental Treatment1 Intervention
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.
Group II: Sub Q insulin to keep glucose less than 180 mg/dLActive Control1 Intervention
This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin human
FDA approved

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaOTHER
947 Previous Clinical Trials
7,396,917 Total Patients Enrolled
Neurological Emergencies Treatment Trials Network (NETT)NETWORK
4 Previous Clinical Trials
6,875 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,349 Previous Clinical Trials
647,026 Total Patients Enrolled
~86 spots leftby Sep 2025
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