Trial · NCT01369069
Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial
NCT01369069, Phase 3, Completed, University of Virginia; results first posted 2019-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial. Trials, record NCT01369069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01369069
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial
- NCT number
- NCT01369069
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,151 participants, actual
- Lead sponsor
- University of Virginia
- Conditions
- Acute Ischemic Stroke, Diabetes, Hyperglycemia
- Interventions
- 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
- First posted
- 2011-06-08
- Last updated
- 2019-12-23
- Results first posted
- 2019-12-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Favorable Modified Rankin Scale (Yes/No) | 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 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. |
| Primary | Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL) | 72 hours | Severe hypoglycemia (blood glucose \< 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period. |
| Secondary | Number of Participants With a Favorable NIHSS | Follow up (Max 164 days) | 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. |
| Secondary | Number of Participants With a Favorable Barthel Index | Follow up (Max 164 days) | 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. |
| Secondary | Stroke Specific Quality of Life (SSQOL) | Follow up (Max 164 days) | Stroke Specific Quality of Life. Scores range from 1-5 with higher scores indicating better quality of life |
| Other | Death | 90 days (+30 days) | Death from any cause |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Favorable Modified Rankin Scale (Yes/No) | 90 days (-14/+30 days) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL) | 72 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Favorable NIHSS | Follow up (Max 164 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Favorable Barthel Index | Follow up (Max 164 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Stroke Specific Quality of Life (SSQOL) | Follow up (Max 164 days) | score on a scale | MEDIAN | |
| OTHER_PRE_SPECIFIED | Death | 90 days (+30 days) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Favorable Modified Rankin Scale (Yes/No) | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 119 | Participants | ||
| Number of Participants With a Favorable Modified Rankin Scale (Yes/No) | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 123 | Participants | ||
| Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL) | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 15 | Participants | ||
| Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL) | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 0 | Participants | ||
| Number of Participants With a Favorable NIHSS | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 152 | Participants | ||
| Number of Participants With a Favorable NIHSS | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 166 | Participants | ||
| Number of Participants With a Favorable Barthel Index | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 271 | Participants | ||
| Number of Participants With a Favorable Barthel Index | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 261 | Participants | ||
| Stroke Specific Quality of Life (SSQOL) | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 3.75 | Inter-Quartile Range 2.98 to 4.40 | score on a scale | |
| Stroke Specific Quality of Life (SSQOL) | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 3.69 | Inter-Quartile Range 3.02 to 4.46 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 581 | |
| Overall Study | STARTED | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 570 | |
| Overall Study | COMPLETED | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 564 | |
| Overall Study | COMPLETED | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 554 | |
| Overall Study | NOT COMPLETED | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 17 | |
| Overall Study | NOT COMPLETED | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 16 |
Source ClinicalTrials.gov
Adverse events464
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 2 | 581 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 6 | 570 | 6 |
| other | Leukocytosis | Blood and lymphatic system disorders | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 4 | 581 | 4 |
| other | Leukocytosis | Blood and lymphatic system disorders | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 2 | 570 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 0 | 581 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 1 | 570 | 1 |
| other | Acute myocardial infarction | Cardiac disorders | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 0 | 581 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 3 | 570 | 3 |
| other | Atrial fibrillation | Cardiac disorders | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 9 | 581 | 9 |
| other | Atrial fibrillation | Cardiac disorders | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 9 | 570 | 9 |
1 to 10 of 464Source ClinicalTrials.gov
See all 464 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 54 | 581 |
| Total, all-cause mortality | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 65 | 570 |
| Total, other adverse events | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 384 | 581 |
| Total, other adverse events | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 134 | 570 |
| Total, serious adverse events | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | 209 | 581 |
| Total, serious adverse events | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 198 | 570 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01NS069498 | The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial | JOHNSTON, KAREN C.; BRUNO, ASKIEL; HALL, CHRISTIANA | UNIVERSITY OF VIRGINIA | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2011 to 2017 |
Source NIH RePORTER
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL vs Sub Q Insulin to Keep Glucose Less Than 180 mg/dL: Number of Participants With a Favorable Barthel Index | Trial comparisons |
| IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL vs Sub Q Insulin to Keep Glucose Less Than 180 mg/dL: Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL) | Trial comparisons |
| IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL vs Sub Q Insulin to Keep Glucose Less Than 180 mg/dL: Death | Trial comparisons |
| IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL vs Sub Q Insulin to Keep Glucose Less Than 180 mg/dL: Number of Participants With a Favorable NIHSS | Trial comparisons |
| IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL vs Sub Q Insulin to Keep Glucose Less Than 180 mg/dL: deaths from any cause | Trial comparisons |
| IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL vs Sub Q Insulin to Keep Glucose Less Than 180 mg/dL: Number of Participants With a Favorable Modified Rankin Scale (Yes/No) | Trial comparisons |
| IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL vs Sub Q Insulin to Keep Glucose Less Than 180 mg/dL: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01369069
GET https://conductscience.org/api/trials/v1/NCT01369069/events?page=2