Who is sponsoring NCT01369069?

NCT01369069 is sponsored by University of Virginia.

What drugs are being tested in NCT01369069?

Interventions in NCT01369069: IV insulin to maintain target glucose concentration of 80-130 mg/dL, Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL.

What condition does NCT01369069 study?

NCT01369069 studies Acute Ischemic Stroke, Diabetes, Hyperglycemia.

Is NCT01369069 still recruiting?

NCT01369069 is currently completed. Last updated 13 December 2019.

Are results published for NCT01369069?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-12-13 · How we verify

NCT01369069: SHINE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

Completed Phase 3 Results posted Last updated 13 December 2019

What this trial tests

Phase 3 trial testing IV insulin to maintain target glucose concentration of 80-130 mg/dL in Acute Ischemic Stroke in 1,151 participants. Completed in 19 November 2018.

Timeline

1 April 2012

Primary endpoint
19 November 2018

19 November 2018

Quick facts

Lead sponsor	University of Virginia
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,151
Start date	1 April 2012
Primary completion	19 November 2018
Estimated completion	19 November 2018
Sites	70 locations across United States

Drugs / interventions tested

IV insulin to maintain target glucose concentration of 80-130 mg/dL — full drug profile →
Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL — full drug profile →

Conditions studied

Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →
Diabetes — all drugs for Diabetes →
Hyperglycemia — all drugs for Hyperglycemia →

Sponsor

University of Virginia

Who can join

18 and older, any sex, with Acute Ischemic Stroke or Diabetes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With a Favorable Modified Rankin Scale (Yes/No)
Time frame: 90 days (-14/+30 days)
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 t
Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)
Time frame: 72 hours
Severe hypoglycemia (blood glucose \< 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial.
Johnston KC, Bruno A, Pauls Q, Hall CE, et al · · 2019 · cited 294× · PMID 31334795 · DOI 10.1001/jama.2019.9346
Intranasal Insulin and Insulin-Like Growth Factor 1 as Neuroprotectants in Acute Ischemic Stroke.
Lioutas VA, Alfaro-Martinez F, Bedoya F, Chung CC, et al · · 2015 · cited 82× · PMID 26040423 · DOI 10.1007/s12975-015-0409-7
The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial protocol: a randomized, blinded, efficacy trial of standard vs. intensive hyperglycemia management in acute stroke.
Bruno A, Durkalski VL, Hall CE, Juneja R, et al · · 2014 · cited 63× · PMID 23506245 · DOI 10.1111/ijs.12045
Insulin for glycaemic control in acute ischaemic stroke.
Bellolio MF, Gilmore RM, Ganti L. · · 2014 · cited 52× · PMID 24453023 · DOI 10.1002/14651858.cd005346.pub4
Considering hyperglycemia and thrombolysis in the Stroke Hyperglycemia Insulin Network Effort (SHINE) trial.
Southerland AM, Johnston KC. · · 2012 · cited 20× · PMID 22994224 · DOI 10.1111/j.1749-6632.2012.06731.x
The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial: an adaptive trial design case study.
Connor JT, Broglio KR, Durkalski V, Meurer WJ, et al · · 2015 · cited 17× · PMID 25885963 · DOI 10.1186/s13063-015-0574-8
Admission hyperglycemia and outcome after intravenous thrombolysis: is there a difference among the stroke-subtypes?
Miedema I, Luijckx GJ, Brouns R, De Keyser J, et al · · 2016 · cited 14× · PMID 27422152 · DOI 10.1186/s12883-016-0617-0
Glucose Control and Risk of Symptomatic Intracerebral Hemorrhage Following Thrombolysis for Acute Ischemic Stroke: A SHINE Trial Analysis.
Southerland AM, Mayer SA, Chiota-McCollum NA, Bolte AC, et al · · 2024 · cited 11× · PMID 38626363 · DOI 10.1212/wnl.0000000000209323

Verify or expand the search:

Other recruiting trials for Acute Ischemic Stroke

Currently open trials in the same condition.

NCT07115940 — Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours · NA · recruiting
NCT07404852 — Non-invasive Vagus Nerve Stimulation to Reduce Inflammation and Brain Injury Blood Biomarkers Following an Acute Ischemi · NA · recruiting
NCT07361302 — A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Pe · Phase 3 · recruiting
NCT07436156 — SUMMIT RISE Study of Acute Ischemic Stroke Patients · Phase 4 · recruiting
NCT07203625 — Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours · Phase 4 · recruiting

Other University of Virginia trials

Trials by the same sponsor.

NCT05880355 — Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI · EARLY_PHASE1 · not yet recruiting
NCT07405645 — Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy · NA · recruiting
NCT07146685 — Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study · Phase 4 · not yet recruiting
NCT07298941 — Resilience Enhancement Following Sleep Treatment · Phase 2 · recruiting
NCT07036315 — Meaning in Music-Based Pain Modulation · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01369069 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Virginia
Last refreshed: 13 December 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01369069.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing