NCT00690287已完成1 期
A Dose-Ranging Study to Evaluate Fasting and Postprandial P-Glucose, Safety and Tolerability After Oral Single, B.I.D and Q.I.D Dosing of AZD6370 in Patients With Diabetes Mellitus: a Randomized, Single-Blind, Placebo-Controlled, Phase I Study
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
- Pharmacodynamic variables
研究概览
简要总结
The purpose of this study is to assess the effect of AZD6370 on blood sugar and to study safety and tolerability in patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated with diet or metformin. Stable glycemic control indicated by no changed treatment within 3 months
- •Diabetes Mellitus diagnosis <5 years
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 investigational product
- •Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results
研究组 & 干预措施
Part A, arm 1
Experimental
- 8 pats: AZD6370 increasing oral single doses a+b+c+placebo together with food
干预措施: AZD6370 (Drug)
Part A, arm 2
Experimental
- 8 pats: AZD6370 increasing oral single doses a+b+c+placebo without food
干预措施: AZD6370 (Drug)
Part B, arm1, 2, and 3
Experimental
- AZD6370 dose x mg o.d.
- dose x/2 mg b.i.d.
- dose x/4 mg q.i.d.
干预措施: AZD6370 (Drug)
Part B, arm 4
Experimental
- Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacodynamic variables
时间窗: Blood samples taken repeatedly during 24 hours on study day sessions
次要结局
- Safety variables(Blood samples taken repeatedly during 24 hours on study day sessions)
- Pharmacokinetic variables(Blood samples taken repeatedly during 24 hours on study day sessions)
研究者
研究点 (1)
Loading locations...
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