NCT01162876已完成3 期
A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of saxagliptin administered before breakfast for 14 consecutive days in patients with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all of the following criteria will be included:
- •HbA1c level ≥7.0% and < 9.0%
- •Fasting glucose level ≥130mg/dL and <210mg/dL
- •Patients who are capable of giving informed consent
- •Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after completion of the study
排除标准
- •Patients with type 1 diabetes mellitus; patients with diabetes mellitus due to other specified drugs, mechanisms, or diseases; and patients with gestational diabetes mellitus
- •Patients with a medical history of diabetic coma
- •Patients with heart failure
- •Patients with a complication of active chronic hepatitis or hepatic cirrhosis
- •Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
- •Patients with a history or complication of malignant tumor
研究组 & 干预措施
saxagliptin
Experimental
5 mg daily for 14days
干预措施: saxaglipitin (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: daily, up to 42days
Concentrations of plasma saxagliptin and BMS-510849
Pharmacodynamics
时间窗: daily, up to 42 days
Plasma DPP4 actyivity Concentrations of blood glucose, C-peptide, insulin and glucagon Plasma active GLP-1 concentration
次要结局
- Safety issues(daily, up to 42 days)
研究者
研究点 (1)
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