Efficacy and Safety of Dapagliflozin for the Hospital Management of Patients With Type 2 Diabetes: a Prospective, Open-label, Non-inferiority Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Noninferiority in mean differences between groups in their daily blood glucose concentrations
研究概览
简要总结
The purpose of the trial is to examine whether treatment with dapagliflozin plus insulin as compared with insulin alone (basal-bolus insulin) will result in similar blood glucose control and similar rate of complications in patients with diabetes, who are admitted to a hospital in a noncritical setting
详细描述
Background
Good glycemic control is crucial for improving clinical outcomes in hospitalized patients with diabetes. Multiple insulin injections (one dose of long-acting insulin and three doses of rapid-acting pre-meal bolus insulins) are the standard of care for the hospital management of patients with diabetes. Sodium-glucose cotransporter 2 (SGLT-2) inhibitors is a class of glucose-lowering agents that are increasingly being used in patients with type 2 diabetes, due to multiple pleiotropic effects. These drugs reduce cardiovascular mortality, especially by reducing risk of heart failure, and also improve renal outcomes. The role of SGLT-2 inhibitors in the treatment of patients admitted to hospital in a non-critical care setting has not been assessed. Accordingly, the proposed study will provide a clinically useful information on the efficacy (blood glucose control) and safety (hypoglycemia) of dapagliflozin (an SGLT-2 inhibitor) for the management of hospitalized patients with type 2 diabetes.
Summary
The purpose of the trial is to examine whether treatment with dapagliflozin plus insulin as compared with insulin alone (basal-bolus insulin) will result in similar blood glucose control and similar rate of complications in patients with diabetes, who are admitted to a hospital in a noncritical setting.
Arms and interventions
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.
- •Study participants must have a randomization total daily dose (TDD) insulin requirement of at least 12 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 long-acting weekly GLP1-RA (weekly exenatide, or dulaglutide).
- •Any known hypersensitivity to dapagliflozin.
- •History of recurrent urinary tract infections (>2 episodes) requiring antibiotic therapy in the last 1 year.
- •History of intolerance to dapagliflozin or any other sodium-glucose cotransporter 2 inhibitors.
- •Patients with history of clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension).
- •Patients with ongoing corticosteroid therapy (equal to a prednisone dose ≥5 mg/day).
- •Patients with impaired renal function (eGFR <45 ml/min/1.73m2).
- •Patients with 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.
- •Body mass index (BMI) <18.5 kg/m2.
研究组 & 干预措施
Dapagliflozin group
Dapagliflozin 10 mg, every day before breakfast. Glargine insulin 300 Units/mL, average dose: 10-20 U/day; Insulin lispro 100 Units/mL, average dose: 10-30 U/day
干预措施: Dapagliflozin (Drug)
Basal-bolus group
Glargine insulin; 300 Units/mL, average dose: 10-20 U/day; Insulin lispro 100 Units/mL, average dose: 10-30 U/day
干预措施: Glargine (Drug)
结局指标
主要结局
Noninferiority in mean differences between groups in their daily blood glucose concentrations
时间窗: The first 7 days of therapy in hospital and 5 days post-discharge
Blood glucose will be measured pre-breakfast, pre-lunch, pre-dinner and night-time (0300 hours). Mean daily blood glucose concentration will be calculated to determine differences in inpatient glycemic control in patients with type 2 diabetes treated with dapagliflozin 10 mg plus basal-bolus insulin or basal-bolus regimen, using glargine U300 as basal insulin and insulin lispro U100 before meals.
次要结局
- Number of basic glucose readings between 70 mg/dl and 180 mg/dl before meals and night-time in hospitalized patients.(The first 7 days of therapy in hospital and 5 days post-discharge.)
- Number of hypoglycemic episodes (BG < 70 mg/dl and 54 mg/dl) in hospitalized patients.(The first 7 days of therapy in hospital and 5 days post-discharge.)
- Number of severe hypoglycemia (< 54 mg/dl) episodes in hospitalized patients.(The first 7 days of therapy in hospital and 5 days post-discharge)
- Continuous Glucose Monitoring(The first 7 days of therapy in hospital and 5 days post-discharge.)
- Daily dose of basal insulin, daily dose of prandial insulin, and total daily dose in hospitalized patients.(The first 7 days of therapy in hospital and 5 days post-discharge.)
- Number of episodes of severe hyperglycemia (BG > 240 mg/dl) in hospitalized patients.(The first 7 days of therapy in hospital and 5 days post-discharge.)
- Hospital complications(The first 7 days of therapy in hospital and 5 days post-discharge.)
- Serum Ketone levels(Day 0, 3 and 5 of randomization)
- Diabetic acidosis(The first 7 days of therapy in hospital and 5 days post-discharge.)
- Glycated hemoglobin(3 Months)
- Fasting blood glucose(3 Months)
- Complete blood count(3 Months)
- Liver function test(3 Months)
- Kidney function test(3 Months)
- A Composite of re-admission for heart failure or for any other reason(3 Months)
- Diuretics Use(3 Months)
研究者
Dr Mohammad Shafi Kuchay
Consultant
Medanta, The Medicity, India