Insulin Degludec Versus Glargine U300 for the Management of Hospitalized Patients With Type 2 Diabetes: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Change in mean daily blood glucose concentration in hospitalized patients
研究概览
简要总结
Limited data exist about the use of insulin degludec and insulin glargine U300 in the hospitalized patients. A previous study compared the safety and efficacy of insulin degludec versus insulin glargine U100 for the management of hospitalized patients with type 2 diabetes. However, there is no data comparing the efficacy and safety of insulin degludec versus insulin glargine U300 for the management of hospitalized patients with type 2 diabetes. Accordingly, the proposed study will provide a clinically useful information on the efficacy (blood glucose control) and safety (hypoglycemia) of insulin degludec versus insulin glargine U300 for the management of hospitalized patients with type 2 diabetes.
详细描述
The purpose of this study is to find out if treatment with insulin degludec when compared to insulin glargine U300 will result in similar blood sugar control in hospitalized patients with type 2 diabetes.
Primary outcome measure
- Change in mean daily blood glucose concentration in hospitalized patients [ Time Frame: The first 7 days of therapy ] Blood glucose will be measured before each meal, bedtime and at 3:00 am. Mean daily blood glucose concentration will be calculated to determine differences in inpatient glycemic control in patients with type 2 diabetes treated with basal bolus regimen or basal plus regimen with insulin degludec or glargine U300 once daily plus insulin glulisine before meals.
Secondary outcome measures
- Number of basic glucose readings between 70 mg/dl and 180 mg/dl before meals in hospitalized patients.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 30 years or above admitted to the hospital for elective CABG surgery
- •A known history of type 2 diabetes treated with any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy except for degludec and glargine U
- •Study participants must have a randomization total daily dose (TDD) insulin requirement of at least 20 units per day.
- •Signed, informed consent prior to any study procedures.
排除标准
- •Subjects with increased BG concentration, but without a known history of diabetes (stress hyperglycemia).
- •Subjects treated with diet alone (no antidiabetic agents) and admission HbA1c <7%.
- •Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.
- •Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, or dulaglutide).
- •Patients with history of clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), ongoing corticosteroid therapy (equal to a prednisone dose ≥5 mg/day), or impaired renal function (eGFR< 30 ml/min), or congestive heart failure (NYHA- IV).
- •Patients with medical and surgical pancreatic disease.
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Known or suspected allergy to trial medication(s), excipients, or related products.
研究组 & 干预措施
Degludec
Study participants with type 2 diabetes undergoing elective coronary artery bypass graft (CABG) surgery will receive 100% of the total daily dose (TDD) given as a basal bolus regimen with degludec once daily plus rapid-acting insulin glulisine before meals.
Degludec insulin 100 Units/mL, average dose: 30-40 U/day; Insulin glulisine 100 Units/mL, average dose: 20-40 U/day
干预措施: Degludec (Drug)
Glargine U300
Study participants with type 2 diabetes undergoing CABG surgery will receive 100% of the total daily dose (TDD) given as a basal bolus regimen with glargine U300 once daily plus rapid-acting insulin glulisine before meals.
Glargine U300;300 Units/mL, average dose: 30-40 U/day; Insulin glulisine 100 Units/mL, average dose: 20-40 U/day
干预措施: Glargine U300 (Drug)
结局指标
主要结局
Change in mean daily blood glucose concentration in hospitalized patients
时间窗: The first 7 days of therapy
Blood glucose will be measured before each meal, bedtime and at 3:00 am. Mean daily blood glucose concentration will be calculated to determine differences in inpatient glycemic control in patients with type 2 diabetes treated with basal bolus regimen or basal plus regimen with insulin degludec or glargine U-300 once daily plus aspart insulin before meals.
次要结局
- Number of basic glucose readings between 70 mg/dl and 180 mg/dl before meals in hospitalized patients(The first 7 days of therapy)
- Number of severe hypoglycemia (< 54 mg/dl) episodes in hospitalized patients(The first 7 days of therapy)
- Daily dose of basal insulin, daily dose of prandial insulin, and total daily dose in hospitalized patients(The first 7 days of therapy)
- Number of episodes of severe hyperglycemia (BG > 240 mg/dl) in hospitalized patients(The first 7 days of therapy)
- Average blood glucose (mg/dL), percentage time in target, percentage time below target, and percentage time above target in a subgroup of study participants.(The first 7 days of therapy)
- Number of hypoglycemic episodes (BG < 70 mg/dl and 54 mg/dl) in hospitalized patients(The first 7 days of therapy)
研究者
Dr Mohammad Shafi Kuchay
Senior Consultant
Medanta, The Medicity, India