Insulin for Hyperglycemia in Stroke Trial
Condition: Hyperglycemia; Stroke, Acute
MeSH terms: Stroke; Hyperglycemia
Intervention: Analog Insulin; Human insulin
Intervention description: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG >15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.
For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is >10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG >15 mmol/L.; Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 452.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hyperglycemia; Stroke; Human insulin; Analog insulin

Summary:

      Introduction: Glycemic control in acutely ill stroke patients with hyperglycemia is vital.
      Although insulin is the choice of anti-diabetic agent during acute stage, it is not clear
      which insulin regimen is better in terms of glycemic control and prevention of hypoglycemia
      in hospitalized acute stroke patients who are usually on small frequent nasogastric tube
      feeding. The present study aims to evaluate the efficacy and safety of human insulin (regular
      insulin and neutral protamine hagedorn, NPH insulin) to analog insulin (basal insulin
      glargine and rapid acting insulin aspart) in hospitalized acute stroke patients with
      hyperglycemia.

      Justification: Analog insulins are developed by minor alteration of the amino acid chain
      which alters their pharmacokinetics and make them more physiological. However, these insulins
      are costly and are not widely available. Conventional human insulins are more commonly used
      in our country. Comparison of these two regimen is necessary in our own setting to optimize
      optimal glycemic management of hospitalized acute stroke patients.

      Methodology: In this single-center, open-label, randomized trial, 100 patients with acute
      stroke and hyperglycemia (capillary blood glucose ≥10 mmol/L on 2 or more occasions) or
      history of type 2 DM admitted in the in-patient Department of Neurology, National Institute
      of Neurosciences (NINS) & Hospital will be randomly assigned to receive human insulin or
      modern insulin therapy in 1:1 ratio. The study will be carried out from February to June
      2021. Blood glucose (BG) will be monitored by standardized glucometer thrice a day and
      insulin dose will be adjusted daily. The primary outcome of the study will be the differences
      in glycemic control between groups, as measured by mean daily BG concentration during the
      hospital stay. Secondary outcomes include differences between treatment groups in any of the
      following measures: number of hypoglycemic events (BG <3.9 mmol/L), total daily dose of
      insulin, length of hospital stay, hospital complications and mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • Patients admitted to adult neurology ward with acute stroke with

               -  Patients having hyperglycemia (capillary blood glucose ≥10 mmol/L in 2 or more
                  occasions or having history of treatment for DM)

               -  Patients with age of 18-80 years of both sexes

               -  Patients or their attendants giving consent to take part in the study

        Exclusion Criteria:

          -  Patients with hyperglycemic emergencies (hyperglycemic hyperosmolar state or diabetic
             ketoacidosis)

               -  Pregnant patients

               -  Those not giving consent to participate in the study