Randomized Controlled Trial Comparing the Safety and Efficacy of Insulin Glargine and Insulin Degludec in Glucocorticoid Induced Hyperglycemia in Hospitalized Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
研究概览
简要总结
Glucocorticoids (GC) represent therapeutic agents of great importance in the treatment and prophylaxis of multiple inflammatory and non-inflammatory conditions. Despite their efficacy, the use of GCs is associated with a variety of side effects, one of the immediate ones being the development of glucocorticoids induced hyperglycemia.
GCs decrease peripheral insulin sensitivity, increase hepatic gluconeogenesis, trigger insulin resistance, as well as inhibit pancreatic insulin production.([1] It has been shown that acute and chronic hyperglycemia that are present in many cases in the hospital setting are important risk factors for prolonged hospital stays, infectious complications, poorer surgical outcomes, and increased mortality.
In-hospital glucocorticoid induced hyperglycemia is usually managed with optimization of oral anti-diabetic drugs and basal bolus insulin, which has been well established over sliding scale insulin as the preferred regimen for GIH. Through this study we aim to compare to different basal insulins, glargine and degludec in terms of their efficacy and safety (hypoglycemic events) in this setting.
详细描述
This study protocol describes a randomized controlled trial conducted at Max Super Specialty Hospital to compare the safety and efficacy of insulin glargine and insulin degludec in the management of glucocorticoid-induced hyperglycemia (GIH) among hospitalized patients. The study is being undertaken as a DNB thesis in the Department of Endocrinology under the guidance of Dr. Ambrish Mithal and colleagues.
Glucocorticoids are widely used in hospitalized patients for inflammatory, autoimmune, respiratory, infectious, and malignant conditions. However, they commonly cause hyperglycemia by increasing insulin resistance, enhancing hepatic gluconeogenesis, promoting lipolysis and proteolysis, and impairing pancreatic beta-cell insulin secretion. Approximately 40-50% of hospitalized patients receiving steroids develop GIH, which is associated with poor clinical outcomes such as prolonged hospitalization, infections, delayed wound healing, intensive care admission, and increased mortality.
The study aims to compare insulin glargine, a long-acting basal insulin with approximately 24-hour duration, and insulin degludec, an ultra-long-acting basal insulin with about 42-hour duration. Degludec is hypothesized to provide similar glycemic control with fewer hypoglycemic episodes because of its flatter and more stable pharmacokinetic profile.
The primary objective is to compare the efficacy of glargine and degludec in reducing mean glucose levels in patients with GIH. Secondary objectives include comparing the incidence of hypoglycemia and identifying predictors of glycemic control.
The study population includes non-pregnant adults above 18 years with type 2 diabetes or without diabetes who are admitted under Respiratory Medicine and are receiving glucocorticoids equivalent to more than 20 mg and less than 160 mg prednisolone daily. Patients already on basal insulin, those receiving steroids for less than 48 hours, pregnant patients, or patients with diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), or requiring insulin infusion are excluded.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non pregnant adult patients
- •with or without Type 2 diabetes
- •above the age of 18 years
- •on glucocorticoid dose equivalent to >20 mg and <160 mg prednisolone daily for any indication
- •with glucocorticoid induced hyperglycemia (random blood glucose >200 mg/dl)
- •who are requiring basal bolus insulin regimen
排除标准
- 未提供