NCT00768105已完成1 期
A Randomized, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Subjects With T2DM Treated With Insulin
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
- 24
- 试验地点
- 1
- 主要终点
- Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables and ECG)
研究概览
简要总结
The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female with non child-bearing potential
- •Diagnosed Diabetes Mellitus patients treated with insulin alone or insulin in combination with other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.
- •HbA1c below or equal to 11 % at screening (HbA1c value according to international DCCT standard)
排除标准
- •Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
- •History of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
- •Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.
研究组 & 干预措施
1
Experimental
干预措施: AZD1656 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables and ECG)
时间窗: Blood samples taken repeatedly during 24 hours on study day sessions
次要结局
- Pharmacokinetic variables(Blood samples taken repeatedly during 24 hours on study day sessions)
- Pharmacodynamic variables(Blood samples taken repeatedly during 24 hours on study day sessions)
研究者
研究点 (1)
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