Acute StrokePhase 3ICASNCT02607943
Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control After Acute Stroke
A Phase 3 study testing Insulin Glargine and Regular Insulin in people with Acute Stroke and Hyperglycemia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Hyperglycemia is common during acute ischemic stroke. However, the optimal strategy to control hyperglycemia during acute ischemic stroke has not been established. The object of this multicenter randomized controlled study is to determine the efficacy and safety of early initiation of subcutaneous once-daily insulin… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Stroke, Hyperglycemia
- What is being tested?
- Insulin Glargine and Regular Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2015to Nov 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who admitted to stroke ICU within 24 hours of acute stroke onset and have repeated random blood glucose >200 mg/dL with a 2 hours interval
Who cannot join
- Patients with age <20 years,
- pregnancy,
- shock, severe infection, end stage renal disease requiring dialysis,
- type I DM or current steroid usage.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Sung-Chun Tang, MD. PhD, +88623123456 ext. 63280, tangneuro@gmail.com
About this study
Official title: Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control After Acute Stroke: A Multi-center, Randomized Control Study
Hyperglycemia is common during acute ischemic stroke. However, the optimal strategy to control hyperglycemia during acute ischemic stroke has not been established. The object of this multicenter randomized controlled study is to determine the efficacy and safety of early initiation of subcutaneous once-daily insulin glargine, in comparison with regular insulin, based on a protocolized sliding scale regimen to achieve proper sugar control in acute stroke patients with hyperglycemia admitted to the intensive care unit.
Read the detailed description
Study Rationale: Hyperglycemia is common during acute ischemic stroke. It has been shown that persistent in-hospital hyperglycemia during the first 24 hours (h) after stroke is associated with worse outcomes than normoglycemia. However, the optimal strategy to control hyperglycemia during acute ischemic stroke has not been established.
Aims: The object of this multicenter randomized controlled study is to determine the efficacy and safety of early initiation of subcutaneous once-daily insulin glargine, in comparison with regular insulin, based on a protocolized sliding scale regimen to achieve proper sugar control in acute stroke patients with hyperglycemia admitted to the intensive care unit (ICU).
Design: This is a 3-year, randomized, multicenter trial. Approximate 120 hyperglycemic acute stroke patients will receive either (a) subcutaneous long acting basal insulin (insulin glargine) with added short acting regular insulin to correct hyperglycemic events or (b) short acting regular insulin pre-meal with added NPH at bed time if start eating, for 72 h, starting within 24 h of stroke symptom onset. The inclusion criteria are patients who admitted to stroke ICU within 24 hours of acute stroke onset and have repeated random blood glucose >200 mg/dL with a 2 hours interval. The exclusion criteria include patients with age <20 years, pregnancy, shock, severe infection, end stage renal disease requiring dialysis, type I DM or current steroid usage. Capillary blood glucose will be measured every 4-hours to adjust the next insulin dose. Glucometric parameters will also be analyzed by continuous blood glucose monitoring system. 10 ml blood and same amount of urine from 24 hours urine collection will be collected every day for further measurement of a variety of blood inflammatory markers and urine catecholamine levels.
Study outcomes: The primary endpoint is the percentage of time in the range of 80-180 mg/dL during the sugar monitoring period. The secondary endpoints include: (1) good functional outcome at 3 months post stroke (modified Rankin Scale <2), (2) stroke in evolution, (3) 24 hours blood glucose variability via continuous glucose monitoring, and (4) blood and urine biomarkers.
In summary, this trial will provide important novel information about preferred management of acute ischemic stroke patients with hyperglycemia. It will determine the potential benefits and risks of application of long acting basal insulin during very early stage of acute stroke.
- Conditions
- Acute Stroke, Hyperglycemia
- Being tested
- Insulin Glargine, Regular Insulin
- Keywords
- acute stroke, hyperglycemia, regular insulin, long-acting insulin
- Medical subject headings
- Stroke, Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlargineDrug
Also called Lantus
Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control
Regular InsulinDrug
Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control
| Study group | Role | What they receive |
|---|---|---|
| Insulin Glargine | Experimental | subcutaneous long acting basal insulin (insulin glargine) with added short acting regular insulin to correct hyperglycemic events Receives: Drug: Insulin Glargine |
| Regular Insulin | Active comparator | short acting regular insulin pre-meal with added NPH at bed time if start eating Receives: Drug: Regular Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of time in the range of 80-180 mg/dL during the sugar monitoring period
Measured: 72 hours after recruitment
Secondary outcomes (5)
Good functional outcome at 3 months post stroke
Good functional outcome is defined as modified Rankin Scale <2
Measured: 3 months after stroke
Stroke in evolution
Stroke in evolution is defined as an increase in the National Institutes of Health Stroke Scale (NIHSS) score of ≥ 2 points excluding other attributable medical or systemic causes.
Measured: one week after stroke onset
Blood glucose variability via continuous glucose monitoring
Blood glucose is monitored 24 hours per day via continuous glucose monitoring for 72 hours after recruitment to evaluate the variability.
Measured: 72 hours after recruitment
Blood biomarkers
Blood biomarkers include soluble form of receptor for glycation end-product (sRAGE), high mobility group box 1(HMGB1), heat shock protein 70 (HSP 70), C-reactive protein (CRP), D-dimer, fibrinogen
Measured: 72 hours after recruitment
Urine biomarkers
Urine biomarkers include catecholamines such as normetanephrine and vanillylmandelic acid (VMA)
Measured: 72 hours after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Taipei Medical University Shuang Ho Hospital
- Responsible party
- Sponsor
- Investigators
- Jiann-Shing Jeng, MD. PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607943
- Sponsor's protocol ID
- 201504075MINC
- Acronym
- ICAS
- Status last verified
- Aug 2016
- First submitted
- 4 Nov 2015
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang SC, Shih SR, Lin SY, Chen CH, Yeh SJ, Tsai LK, Yang WS, Jeng JS. A randomized trial to investigate the efficacy and safety of insulin glargine in hyperglycemic acute stroke patients receiving intensive care. Sci Rep. 2021 Jun 1;11(1):11523. doi: 10.1038/s41598-021-91036-2.
PubMed 34075142
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control After Acute Stroke: A Multi-center, Randomized Control Study
- ClinicalTrials.gov ID
- NCT02607943
- Acronym / sponsor ID
- ICAS / 201504075MINC
- Conditions
- Acute Stroke, Hyperglycemia
- Keywords
- acute stroke, hyperglycemia, regular insulin, long-acting insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Taipei Medical University Shuang Ho Hospital
- Study start
- Dec 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperglycemia is common during acute ischemic stroke. However, the optimal strategy to control hyperglycemia during acute ischemic stroke has not been established. The object of this multicenter randomized controlled study is to determine the efficacy and safety of early initiation of subcutaneous once-daily insulin glargine, in comparison with regular insulin, based on a protocolized sliding scale regimen to achieve proper sugar control in acute stroke patients with hyperglycemia admitted to the intensive care unit.
Detailed description
Study Rationale: Hyperglycemia is common during acute ischemic stroke. It has been shown that persistent in-hospital hyperglycemia during the first 24 hours (h) after stroke is associated with worse outcomes than normoglycemia. However, the optimal strategy to control hyperglycemia during acute ischemic stroke has not been established.
Aims: The object of this multicenter randomized controlled study is to determine the efficacy and safety of early initiation of subcutaneous once-daily insulin glargine, in comparison with regular insulin, based on a protocolized sliding scale regimen to achieve proper sugar control in acute stroke patients with hyperglycemia admitted to the intensive care unit (ICU).
Design: This is a 3-year, randomized, multicenter trial. Approximate 120 hyperglycemic acute stroke patients will receive either (a) subcutaneous long acting basal insulin (insulin glargine) with added short acting regular insulin to correct hyperglycemic events or (b) short acting regular insulin pre-meal with added NPH at bed time if start eating, for 72 h, starting within 24 h of stroke symptom onset. The inclusion criteria are patients who admitted to stroke ICU within 24 hours of acute stroke onset and have repeated random blood glucose >200 mg/dL with a 2 hours interval. The exclusion criteria include patients with age <20 years, pregnancy, shock, severe infection, end stage renal disease requiring dialysis, type I DM or current steroid usage. Capillary blood glucose will be measured every 4-hours to adjust the next insulin dose. Glucometric parameters will also be analyzed by continuous blood glucose monitoring system. 10 ml blood and same amount of urine from 24 hours urine collection will be collected every day for further measurement of a variety of blood inflammatory markers and urine catecholamine levels.
Study outcomes: The primary endpoint is the percentage of time in the range of 80-180 mg/dL during the sugar monitoring period. The secondary endpoints include: (1) good functional outcome at 3 months post stroke (modified Rankin Scale <2), (2) stroke in evolution, (3) 24 hours blood glucose variability via continuous glucose monitoring, and (4) blood and urine biomarkers.
In summary, this trial will provide important novel information about preferred management of acute ischemic stroke patients with hyperglycemia. It will determine the potential benefits and risks of application of long acting basal insulin during very early stage of acute stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Glargine | Experimental | Drug: Insulin Glarginesubcutaneous long acting basal insulin (insulin glargine) with added short acting regular insulin to correct hyperglycemic events |
| Regular Insulin | Active comparator | Drug: Regular Insulinshort acting regular insulin pre-meal with added NPH at bed time if start eating |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who admitted to stroke ICU within 24 hours of acute stroke onset and have repeated random blood glucose >200 mg/dL with a 2 hours interval
Key exclusion criteria (4 listed)
- Patients with age <20 years,
- pregnancy,
- shock, severe infection, end stage renal disease requiring dialysis,
- type I DM or current steroid usage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin GlargineAlso: LantusInsulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control | Drug | Insulin Glargine |
| Regular InsulinInsulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control | Drug | Regular Insulin |
Primary outcome
The percentage of time in the range of 80-180 mg/dL during the sugar monitoring period
Time frame: 72 hours after recruitment
5 secondary outcomes
Good functional outcome at 3 months post stroke
Time frame: 3 months after stroke
Stroke in evolution
Time frame: one week after stroke onset
Blood glucose variability via continuous glucose monitoring
Time frame: 72 hours after recruitment
Blood biomarkers
Time frame: 72 hours after recruitment
Urine biomarkers
Time frame: 72 hours after recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Derived from this study: PubMed 34075142Tang SC, Shih SR, Lin SY, Chen CH, Yeh SJ, Tsai LK, Yang WS, Jeng JS. A randomized trial to investigate the efficacy and safety of insulin glargine in hyperglycemic acute stroke patients receiving intensive care. Sci Rep. 2021 Jun 1;11(1):11523. doi: 10.1038/s41598-021-91036-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiann-Shing Jeng, MD. PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Glargine and Regular Insulin in people with Acute Stroke and Hyperglycemia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung-Chun Tang, MD. PhD (886-2-23563279, tangneuro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of time in the range of 80-180 mg/dL during the sugar monitoring period (time frame: 72 hours after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02607943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.