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Insulin
Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial (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
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
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
- High Blood Sugar
- Diabetes
- Stroke
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days (-14/+30 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days (-14/+30 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)
Number of Participants With a Favorable Modified Rankin Scale (Yes/No)
Secondary study objectives
Number of Participants With a Favorable Barthel Index
Number of Participants With a Favorable NIHSS
Stroke Specific Quality of Life (SSQOL)
Other study objectives
Death
Side effects data
From 2018 Phase 3 trial • 1151 Patients • NCT0136906954%
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%
Other (combined AEs happened only once)
1%
Pyrexia
1%
Pain in extremity
1%
Haemorrhage
1%
Contusion
1%
Bradycardia
1%
Pulmonary embolism
1%
Cardiac arrest
1%
Cardiac failure
1%
Cardiac failure congestive
1%
Haemorrhage intracranial
1%
Renal failure acute
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
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
977 Previous Clinical Trials
7,399,766 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
1,382 Previous Clinical Trials
651,195 Total Patients Enrolled
University of VirginiaLead Sponsor
784 Previous Clinical Trials
1,315,199 Total Patients Enrolled
Karen C Johnston, MD, MScStudy ChairUniversity of Virginia
Valerie Durkalski, PhDPrincipal InvestigatorMedical University of South Carolina
Christiana Hall, MD, MSPrincipal InvestigatorUT Southwestern
Askiel Bruno, MD, MSPrincipal InvestigatorAugusta University
William Barsan, MDPrincipal InvestigatorUniversity of Michigan
4 Previous Clinical Trials
1,955 Total Patients Enrolled
Kevin Barrett, MDPrincipal InvestigatorMayo Clinic