Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Mean Daily Blood Glucose Levels During Hospital
研究概览
简要总结
The purpose of this research study is to test the safety and efficacy of a drug called saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c ≤7.0% on ≤ 2 non-insulin agents at home.
详细描述
The current professional organization guidelines recommend insulin as the preferred treatment for hospitalized patients. It is recommended that most critically ill patients should receive insulin infusion therapy and non-critically ill patients should receive basal bolus insulin therapy in the hospital.
The study will test the hypothesis that treatment with saxagliptin is non-inferior to treatment with basal bolus insulin in this group of patients during their hospital stay. The study will evaluate the effect of saxagliptin, a DPP4 inhibitor, on glycemic control in non-critically ill hospitalized patients with type 2 diabetes mellitus (T2DM)
The primary outcome will be mean daily blood glucose levels during hospital days 2 to 5. The study is designed to detect a non-inferiority margin of 20% in the saxagliptin group as compared to the control group
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T2DM and HbA1C ≤7.5% on ≤1 non-insulin hypoglycemic agent or HbA1C ≤7.0% on ≤2 non-insulin hypoglycemic agents admitted to the hospital for a non-critical illness.
- •Written informed consent.
排除标准
- •Admitted to or expected to require admission to ICU
- •Patients with a history of diabetic ketoacidosis or hyperosmolar state
- •HbA1c >7.5% at the time of admission or within 3 months before admission
- •Insulin requiring before admission
- •Unable to take oral food or medications
- •Systemic steroid use
- •Pregnancy or breastfeeding
- •Women of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.
- •History of pancreatitis or active gallbladder disease
- •End stage renal disease on dialysis
- •Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors
- •Subject unable to give informed consent
研究组 & 干预措施
Saxagliptin group
DPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime.
干预措施: Saxagliptin (Drug)
结局指标
主要结局
Mean Daily Blood Glucose Levels During Hospital
时间窗: Hospital days 2-5
mean of average daily blood blood glucose for each patient day
次要结局
- Percentage of Blood Glucose Readings in 70-140 mg/dL Range(Days 2 to 5)
- Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)(Days 2 to 5)
- Length of Hospital Stay(Admission to discharge, an expected average of 5 days)
- Incidence of Hypoglycemia (BG <70 mg/dL)(Days 2 to 5)
- Variability in Glucose Levels(Days 2 to 5)
- Dose of Insulin(Days 2 to 5)
- Patient Satisfaction(At the time of discharge or Day 5)
研究者
Rajesh K. Garg
Rajesh Garg, MD
Brigham and Women's Hospital