Insulin for Hyperglycemia in Stroke Trial

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.