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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

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)

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

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 • NCT01369069

54%

Hypoglycaemia

Haemorrhagic transformation stroke

Respiratory failure

Ischaemic stroke

Pneumonia

Urinary tract infection

Stroke in evolution

Brain oedema

Atrial fibrillation

Hypokalaemia

Headache

Neurological decompensation

Cerebrovascular accident

Pyrexia

Other (combined AEs happened only once)

Pulmonary embolism

Pain in extremity

Haemorrhage

Contusion

Bradycardia

Cardiac arrest

Cardiac failure

Cardiac failure congestive

Haemorrhage intracranial

Renal failure acute

Transient ischaemic attack

Hypertension

Hypotension

Acute myocardial infarction

Myocardial infarction

Cerebral haemorrhage

Embolic stroke

Aspiration

Dyspnoea

Pneumonia aspiration

Leukocytosis

Nausea

Vomiting

Urinary retention

Sepsis

Convulsion

Deep vein thrombosis

Blood chloride increased

White blood cell count increased

Hypocalcaemia

Hypomagnesaemia

100%

80%

60%

40%

20%

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

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