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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 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.

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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.

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

FieldValue
Enrollment Target 1,151 participants
Start Date 2012-04
Est. Completion 2018-11-19
Phase Phase 3

Sponsor

University of Virginia

449 total trials

What the Registry Record Tells You About NCT01369069

The ClinicalTrials.gov registry entry for NCT01369069 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,151 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,025-participant average among 338 other Diabetes trials with a reported enrollment target (62% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.