Project title
多中心隨機試驗比較長效型甘精胰島素與常規型胰島素在急性中風後血糖控制的有效性與安全性研究
Internal ID
MOST104-2314-B002-220-MY3
Principal Investigator
Start Date
August 1, 2015
End Date
July 12, 2016
Investigators
Organizations
Partner Organizations
Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control after Acute Stroke: a Multi-Center, Randomized Control Study = 多中心隨機試驗比較長效型甘精胰島素與常規型胰島素在急性中風後血糖控制的有效性與安全性研究
Keywords
急性中風
高血糖
長效胰島素
短效胰島素
acute stroke
hyperglycemia
insulin glargine
regular insulin
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 hyperglycemicacute stroke patients who 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 willalso 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 thepercentage 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.