A Phase 3 interventional study of Insulin Glargine and Regular Insulin in Acute Stroke and Hyperglycemia, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-08-19.
Sponsored by National Taiwan University Hospital · Phase 3, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
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Exclusion Criteria:
subcutaneous long acting basal insulin (insulin glargine) with added short acting regular insulin to correct hyperglycemic events
Drug: Insulin Glargine
short acting regular insulin pre-meal with added NPH at bed time if start eating
Drug: Regular Insulin
Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control
Also known as: Lantus
Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control
The percentage of time in the range of 80-180 mg/dL during the sugar monitoring period
Time frame: 72 hours after recruitment
Good functional outcome at 3 months post stroke
Good functional outcome is defined as modified Rankin Scale \<2
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 72 hours after recruitment
Urine biomarkers
Urine biomarkers include catecholamines such as normetanephrine and vanillylmandelic acid (VMA)
Time frame: 72 hours after recruitment
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital