Efficacy and Safety of Human Insulin Versus Analog Insulin in Hospitalized Acute Stroke Patients With Hyperglycemia: a Randomized, Open-label, Single Center Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 452
- 试验地点
- 1
- 主要终点
- Glycemic Control
研究概览
简要总结
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.
详细描述
METHODOLOGY:
Type of study: Single-center, open-label, randomized trial Place of Study: Department of Neurology, National Institute of Neurosciences & Hospital, Dhaka.
Study Period: February to June, 2021 Study population: Patients admitted in the Department of Neurology with acute stroke and hyperglycemia
Sample Size:
Sample size was calculated according to following formula for non-inferiority trial (17):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •Patients with hyperglycemic emergencies (hyperglycemic hyperosmolar state or diabetic ketoacidosis)
- •Pregnant patients
- •Those not giving consent to participate in the study
研究组 & 干预措施
Analog insulin arm
Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.
干预措施: Analog Insulin (Drug)
Human insulin arm
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
干预措施: Human insulin (Drug)
结局指标
主要结局
Glycemic Control
时间窗: During the hospital stay assessed up to 10 days
Differences in glycemic control between groups, as measured by mean blood glucose concentration
次要结局
- Total Daily Dose of Insulin(During the hospital stay assessed up to 10 days)
- Mortality(During the hospital stay assessed up to 10 days)
- Length of Hospital Stay(During the hospital stay assessed up to 10 days)
研究者
Dr. Mashfiqul Hasan
Assistant Professor (Endocrinology)
National Institute of Neurosciences and Hospital, Dhaka