Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

Diabetes Clinical Trial

— SHINE  

Official title:

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369069
• Other study ID #: 15959
• Secondary ID: U01NS069498
• Status: Completed
• Phase: Phase 3
• Start date: April 2012
• Est. completion date: November 19, 2018

Study information

• Verified date: December 2019
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

Eligible subjects must be randomized within 12 hours of stroke symptom onset and either have type 2 diabetes and glucose concentrations of over 110 mg/dL or no history of diabetes and glucose concentrations of 150 mg/dL or higher on initial evaluation. The enrolling sites include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study evaluates the safety and efficacy of targeted glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1151
• Est. completion date: November 19, 2018
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or older

2. Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH).

3. Randomization must be within 12 hours after stroke symptom onset and treatment is recommended, but not required, to begin within 3 hours after hospital arrival. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal.

4. Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose =150 mg/dL in those w/o known diabetes mellitus

5. Baseline NIHSS score of 3-22

6. Pre-stroke modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7. Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of 8-22.

7. Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines.

Exclusion Criteria:

1. Known history of type 1 diabetes mellitus

2. Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment

3. Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded.

4. Pregnant or breast-feeding at the time of study entry

5. Other serious conditions that make the patient unlikely to survive 90 days

6. Inability to follow the protocol or return for the 90 day follow up

7. Renal dialysis (including hemo or peritoneal dialysis)

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Diabetes
• Hyperglycemia
• Stroke

Intervention

Drug:
• IV insulin to maintain target glucose concentration of 80-130 mg/dL
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/dL
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.

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Summa Akron City Hospital	Akron	Ohio
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital - Midtown	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Augusta University Medical Center	Augusta	Georgia
United States	Dell Seton Medical Center at UT	Austin	Texas
United States	Seton Medical Center	Austin	Texas
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Lincoln Medical and Mental Health Center	Bronx	New York
United States	Kings County Hospital	Brooklyn	New York
United States	SUNY Downstate University Hospital of Brooklyn	Brooklyn	New York
United States	Buffalo General Medical Center	Buffalo	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Wexner Medical Center	Columbus	Ohio
United States	UT Southwestern-Parkland Memorial Hospital	Dallas	Texas
United States	UT Southwestern-Zale Lipshy University Hospital	Dallas	Texas
United States	Miami Valley Hospital	Dayton	Ohio
United States	Detroit Receiving Hospital	Detroit	Michigan
United States	Henry Ford Health System	Detroit	Michigan
United States	Sinai-Grace Hospital	Detroit	Michigan
United States	JFK Medical Center	Edison	New Jersey
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Valley Baptist Medical Center	Harlingen	Texas
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	Memorial Herman Hospital	Houston	Texas
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Kentucky	Lexington	Kentucky
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Ronald Regan Medical Center	Los Angeles	California
United States	Jackson Memorial Hospital	Miami	Florida
United States	Froedtert Memorial Hospital	Milwaukee	Wisconsin
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota
United States	West Virginia University	Morgantown	West Virginia
United States	St. Thomas Neuroscience Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Maimonides Medical Center	New York	New York
United States	The Mount Sinai Medical Center	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC - Mercy	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan
United States	University of Utah	Salt Lake City	Utah
United States	California Pacific Medical Center - Davies Campus	San Francisco	California
United States	California Pacific Medical Center-Pacific Campus	San Francisco	California
United States	San Francisco General Hospital	San Francisco	California
United States	UCSF Medical Center	San Francisco	California
United States	Harborview Medical Center	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California
United States	William Beaumont Hospital-Troy	Troy	Michigan
United States	University of Arizona	Tucson	Arizona
United States	University of Arizona Medical Center - South Campus	Tucson	Arizona
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	WellSpan York Hospital	York	Pennsylvania

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

Johnston KC, Bruno A, Pauls Q, Hall CE, Barrett KM, Barsan W, Fansler A, Van de Bruinhorst K, Janis S, Durkalski-Mauldin VL; Neurological Emergencies Treatment Trials Network and the SHINE Trial Investigators. Intensive vs Standard Treatment of Hyperglyce — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death	Death from any cause	90 days (+30 days)
Primary	Number of Participants With a Favorable Modified Rankin Scale (Yes/No)	Favorable for the primary efficacy outcome is defined as modified Rankin Scale (mRS) score of 0 in patients with mild stroke (baseline NIHSS 3-7), mRS 0 or 1 in patients with moderate stroke (baseline NIHSS 8-14), and mRS 0, 1 or 2 in patients with severe stroke (baseline NIHSS 15-22) at 90 days with a pre-specified range of acceptable days of 76 -120 days. The mRS is a stroke outcome scale used to assess functional status after stroke. It consists of seven levels (0-6) where 0 indicates no residual symptoms at all, 5 indicates severe disability and 6 indicates death. The person collecting the mRS score was to be blinded to the participant's treatment group assignment.	90 days (-14/+30 days)
Primary	Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)	Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period.	72 hours
Secondary	Number of Participants With a Favorable NIHSS	The NIHSS (National Institutes of Health Stroke Scale) score ranges from 0 to 42, with higher scores indicating greater neurological deficits. A favorable NIHSS was defined as a score of 0 or 1 on the NIHSS at 90 days post randomization.	Follow up (Max 164 days)
Secondary	Number of Participants With a Favorable Barthel Index	Favorable outcomes for the Barthel Index was defined as a score of 95-100 on the BI at 90 days post randomization. Barthel - Barthel Index for Activities of Daily Living (ADL) assesses functional independence, generally in stroke patients. Scores range from 0-100 with higher scores indicating greater ability to perform activities of daily living.	Follow up (Max 164 days)
Secondary	Stroke Specific Quality of Life (SSQOL)	Stroke Specific Quality of Life. Scores range from 1-5 with higher scores indicating better quality of life	Follow up (Max 164 days)

External Links

•   General information of trial