Clinical trial NCT02607943: Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control After Acute Stroke
Official title: Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control After Acute Stroke: A Multi-center, Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Stroke
Hyperglycemia
Keywords: acute stroke
hyperglycemia
regular insulin
long-acting insulin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
name: Taipei Medical University Shuang Ho Hospital
First posted: 2015-11-18
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with age \<20 years,
* pregnancy,
* shock, severe infection, end stage renal disease requiring dialysis,
* type I DM or current steroid usage.

Primary outcomes:
measure: The percentage of time in the range of 80-180 mg/dL during the sugar monitoring period
timeFrame: 72 hours after recruitment
Secondary outcomes:
measure: Good functional outcome at 3 months post stroke
timeFrame: 3 months after stroke
measure: Stroke in evolution
timeFrame: one week after stroke onset
measure: Blood glucose variability via continuous glucose monitoring
timeFrame: 72 hours after recruitment
measure: Blood biomarkers
timeFrame: 72 hours after recruitment
measure: Urine biomarkers
timeFrame: 72 hours after recruitment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jiann-Shing Jeng, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.