Efficacy and Safety of Continuous Intravenous Versus Usual Subcutaneous Insulin in Acute Ischemic Stroke "INSULINFARCT"

Completed

Phase 2/3 Results N/A

Trial Description

Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome. But the modalities of glucose lowering are still debated. This study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke.

Detailed Description

It is demonstrated that post-stroke hyperglycaemia is associated with poor outcome. Yet, the efficiency of aggressive insulin serum glucose control is not established. Furthermore the modalities of insulin administration are discussed since US and European guidelines recommend subcutaneous administration, whereas some groups use intravenous administration of insulin. The purpose of this study is to compare the efficacy and the safety of a continuous intravenous insulin protocol versus classical subcutaneous administration of insulin. The study will include carotid territory stroke at the acute stage (< 6 hours of onset) confirmed by MRI, and randomized in intravenous versus subcutaneous insulin. The percentage of patients in the target range (mean capillary glycaemia within 24 hours < 7 mmol/l) is the primary outcome. The secondary outcomes include comparison of Modified Rankin Scale at 3 months, rate of hypoglycaemic events and comparison of Infarct Growth as measured on MRI.

Conditions

Interventions

  • Insulin Drug
    Intervention Desc: Insulin
    ARM 1: Kind: Experimental
    Label: 2
    Description: Insulin

Trial Design

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

Patient Involvement

Patients will have stroke confirmed by MRI, then be randomized in intravenous versus subcutaneous insulin. Patients will have blood for glucose level to confirm hyperglycemia and include comparison of Modified Rankin Scale at 3 months, rate of hypoglycaemic events and comparison of Infarct Growth as measured on MRI.

Outcomes

Type Measure Time Frame Safety Issue
Primary Percentage of patients in the glucose target range within 24 hours of the initiation of treatment.
Secondary Modified Rankin Scale at three months; Magnetic resonance imaging (MRI) infarct growth at one day; percentage of patients with hypoglycaemic event (< 3 mmol/l).
Primary Percentage of patients in the glucose target range within 24 hours of the initiation of treatment. 24 hours Yes
Secondary Modified Rankin Scale at three months three months Yes
Secondary Magnetic resonance imaging (MRI) infarct growth at one day one day Yes
Secondary Percentage of patients with hypoglycaemic event (< 3 mmol/l) during the study Yes

Sponsors