NCT00538174已完成1 期
A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapagliflozin in Diabetic Japanese Subjects
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
- 36
- 试验地点
- 1
- 主要终点
- Clinical labs
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese male and female subjects
- •Ages 20 to 70 years old
- •Established diagnosis of T2DM
- •BMI < 32 kg/m2
- •Fasting glucose ≤ 240 mg/dL, while on antidiabetic diet alone
- •HbA1C 6.0 - 10.0%
排除标准
- •Symptomatic T2DM defined as polyuria and/or polydipsia within 2 months of enrollment
- •History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
- •History of incontinence or bladder dysfunction including nocturia
研究组 & 干预措施
Arm 1
Experimental
2.5 mg
干预措施: Dapagliflozin (Drug)
Arm 2
Experimental
10 mg
干预措施: Dapagliflozin (Drug)
Arm 3
Experimental
20 mg
干预措施: Dapagliflozin (Drug)
Arm 4
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Clinical labs
时间窗: scr, Days -1, 2, 7, 12, 14, 15, 21
Urine safety markers
时间窗: Days -1, 1, 14
AEs, vital signs & physical exam
时间窗: scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21
ECGs
时间窗: scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21
次要结局
- Serum glucose, serum insulin, serum c-peptide(Days -1, 1, 14)
- 24h urine(Days -1, 1 & 14 for glucose, creatinine & calcium)
- 24 hr PK blood & urine samples(Days 1 & 14)
- Serum fructosamine(Days -1, 14, 4 h)
- OGTT(Days -2, 13 (after 10 h fast))
研究者
研究点 (1)
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