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NCT01369069 · ClinicalTrials.gov registry record · Phase 3
Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial
A Phase 3 study of Diabetes and Hyperglycemia, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,151
- Enrollment target
- 20
- Study locations
NCT01369069: Completed Phase 3 study of Diabetes and Hyperglycemia, sponsored by University of Virginia.
NCT01369069 is a Phase 3 study of Diabetes and Hyperglycemia that has completed, run by University of Virginia. The registered enrollment target is 1,151 participants, below the 3,025-participant average among 338 other Diabetes trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01369069, a Phase 3 study of Diabetes and Hyperglycemia, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,151 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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 resi
Conditions Studied
Interventions
- DRUG IV insulin to maintain target glucose concentration of 80-130 mg/dL
- DRUG Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL
Study Locations (20)
California
- Long Beach Memorial Medical Center - Long Beach
- Ronald Regan Medical Center - Los Angeles
- San Francisco General Hospital - San Francisco
- California Pacific Medical Center - Davies Campus - San Francisco
- California Pacific Medical Center-Pacific Campus - San Francisco
- UCSF Medical Center - San Francisco
- Stanford University Medical Center - Stanford
Georgia
- Emory University Hospital - Midtown - Atlanta
- Emory University Hospital - Atlanta
- Grady Memorial Hospital - Atlanta
- Augusta University Medical Center - Augusta
Arizona
- University of Arizona Medical Center - South Campus - Tucson
- University of Arizona - Tucson
Florida
- Mayo Clinic Jacksonville - Jacksonville
- Jackson Memorial Hospital - Miami
Illinois
- Northwestern Memorial Hospital - Chicago
- OSF Saint Francis Medical Center - Peoria
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Iowa
- University of Iowa Hospitals & Clinics - Iowa City
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,151 participants |
| Start Date | 2012-04 |
| Est. Completion | 2018-11-19 |
| Phase | Phase 3 |
What the finished NCT01369069 record still lists
NCT01369069 is an interventional study that assigns participants to a tested intervention. Its 1,151 participants enrollment target places it among the larger protocols in the corpus, below the 3,025-participant average among 338 other Diabetes trials with a reported enrollment target (62% lower).
The record links to 3 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which IV insulin to maintain target glucose concentration of 80-130 mg/dL is the first listed.
NCT01369069 names 20 study sites across 8 states, led by California, Georgia, Arizona.
Frequently Asked Questions
What is clinical trial NCT01369069 about?
NCT01369069 is a clinical study titled "Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial". 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 con...
What is the current status of trial NCT01369069?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,151 participants. The study started on 2012-04. Estimated completion is 2018-11-19.
What conditions does trial NCT01369069 study?
This clinical trial studies the following conditions: Diabetes, Hyperglycemia, Acute Ischemic Stroke.
What interventions are being tested in trial NCT01369069?
The interventions under investigation include: IV insulin to maintain target glucose concentration of 80-130 mg/dL (DRUG), Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL (DRUG).
Who is sponsoring clinical trial NCT01369069?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01369069 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01369069's enrollment target sits among peer trials
1,151 38th of 338 higher than 301 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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