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.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Neurosciences and Hospital, Dhaka