NCT00554450已完成1 期
The Pharmacodynamics, Pharmacokinetics, and Safety of Dapagliflozin in Type 2 Diabetic Subjects With Mild, Moderate, and Severe Renal Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Urine will be collected over a 24 h period for determination of renal glucose clearance, total protein, and measurement of total glucose excreted in urine
研究概览
简要总结
The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type 2 diabetic and healthy subjects with normal renal function
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects in the following groups:
- •Group A: Healthy Subjects with Normal Renal Function (CLcr > 80 mL/min) Group B: Diabetic Subjects with Normal Renal Function (CLcr > 80 mL/min) Group C: Diabetic Subjects with Mild Renal Impairment (CLcr > 50 - ≤80 mL/min) Group D: Diabetic Subjects with Moderate Renal Impairment (CLcr ≥ 30 - ≤50 mL/min) Group E: Diabetic Subjects with Severe Renal Impairment (CLcr < 30 mL/min) (and not receiving dialysis)
- •Men and WOCBP, ages 18 to 79 years old
- •Standard Exclusion Criteria, plus:
- •History of diabetic ketoacidosis
- •HbA*1c > 10%
- •Serum albumin < 2.0 gm/dL
- •Potassium < 3.0 or > 6.0 mEq/L
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Experimental
50 mg single dose
干预措施: Dapagliflozin (Drug)
Arm 2
Experimental
20 mg up to 7 days
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Urine will be collected over a 24 h period for determination of renal glucose clearance, total protein, and measurement of total glucose excreted in urine
时间窗: on Days -1, 1, 4 and 10
Blood and urine PK samples
时间窗: on Days 1, 4, 10
Blood samples for serum glucose and creatinine will be collected
时间窗: on Days -1, 1, 4 and 10 at selected timepoints
Iohexol PK blood & urine samples for GFR assessment
时间窗: on Day -12 to -5
次要结局
- ECGs(scr, Days,-1, 4, 7, discharge)
- AEs, vital signs(scr, Days -1, 1, 4-11, discharge)
- physical exams(scr, Days -12 to -5, -1, discharge)
- clinical labs(scr, Day -1, 1, 4, 6, 8, 10, discharge)
- The following urine/serum safety parameters will be assessed: sodium, potassium, magnesium, phosphorus, calcium, and total protein (urine only)(on Days -1, 1, 4 and 10)
研究者
研究点 (4)
Loading locations...
相似试验
终止
1 期
Renal Mechanism of Action/Splay vs. TmGDiabetes, NOSNCT00726505AstraZeneca1
已完成
1 期
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)Type 2 Diabetes MellitusNCT01165268AstraZeneca24
招募中
3 期
Renoprotective Effects of Dapagliflozin Versus Pentoxiphylline in Chronic Kidney Disease PatientsChronic Kidney DiseasesNCT06421870Ain Shams University210
已完成
3 期
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney DiseaseChronic Kidney DiseaseNCT03036150AstraZeneca4,304
招募中
4 期
Dapagliflozin on Renal Morphology and Renal Perfusion in Patients One Year After Kidney TransplantationChronic Kidney DiseasesNCT06560801University of Erlangen-Nürnberg Medical School48