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

Hyperglycemia Clinical Trial

— ICAS  

Official title:

Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control After Acute Stroke: A Multi-center, Randomized Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02607943
• Other study ID #: 201504075MINC
• Status: Recruiting
• Phase: Phase 3
• First received: November 4, 2015
• Last updated: August 17, 2016
• Start date: December 2015
• Est. completion date: November 2018

Study information

• Verified date: August 2016
• Source: National Taiwan University Hospital
• Contact: Sung-Chun Tang, MD. PhD
• Phone: 886-2-23563279
• Email: tangneuro[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stroke
• Hyperglycemia
• Stroke

Intervention

Drug:
• Insulin Glargine
Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control
• Regular Insulin
Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Chang Gung Memorial Hospital, Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	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	Good functional outcome is defined as modified Rankin Scale <2	3 months after stroke	No
Secondary	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.	one week after stroke onset	No
Secondary	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.	72 hours after recruitment	No
Secondary	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	72 hours after recruitment	No
Secondary	Urine biomarkers	Urine biomarkers include catecholamines such as normetanephrine and vanillylmandelic acid (VMA)	72 hours after recruitment	No