Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control After Acute Stroke "ICAS"

Recruiting

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Insulin glargine Drug
    Other Names: Lantus
    Intervention Desc: Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control
    ARM 1: Kind: Experimental
    Label: Insulin Glargine
    Description: subcutaneous long acting basal insulin (insulin glargine) with added short acting regular insulin to correct hyperglycemic events
  • Regular Insulin Drug
    Intervention Desc: Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control
    ARM 1: Kind: Experimental
    Label: Regular Insulin
    Description: short acting regular insulin pre-meal with added NPH at bed time if start eating

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The percentage of time in the range of 80-180 mg/dL during the sugar monitoring period 72 hours after recruitment No
Secondary Good functional outcome at 3 months post stroke 3 months after stroke No
Secondary Stroke in evolution one week after stroke onset No
Secondary 24 hours blood glucose variability via continuous glucose monitoring 72 hours after recruitment No
Secondary Blood biomarkers 72 hours after recruitment No
Secondary Urine biomarkers 72 hours after recruitment No
Secondary Blood glucose variability via continuous glucose monitoring 72 hours after recruitment No

Sponsors