NCT00995787已完成1 期
A Randomized, Single-blind, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 Compared to Placebo in T2DM Patients Treated With Metformin and Sulfonylurea
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
- 75
- 试验地点
- 1
- 主要终点
- Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG
研究概览
简要总结
The primary aim of this study is to evaluate the safety and tolerability of AZD1656 in T2DM patients treated with metformin and sulfonylurea.
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
- 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
- •Male or females of non-childbearing potential
- •Patients treated with a combination of Metformin and SU (glyburide, glimepiride, glibenclamide, glipizide or gliclazide) in stable doses for at least 2 months prior to enrolment visit
- •Patients should have FPG in the range of 6,0 to 14 mmol/L (108 to 250 mg/dL) at enrolment and on the morning of randomisation
排除标准
- •History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
- •Impaired renal function in terms of GFR<60 ml/min
- •Use of insulin, glitazones, gemfibrozil, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, e.g., ketoconazole within 14 days before randomisation
研究组 & 干预措施
AZD1656
Experimental
干预措施: AZD1656 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG
时间窗: AE will be collected from the time for randomisation until follow-up visit. Safety variables and vital signs will be measured at the pre-entry, during study days -2 to 10 and at the follow-up visit.
次要结局
- Pharmacokinetic variables: (Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)(Blood samples for analysis of plasma concentrations of AZD1656 will be collected on study days 6 and 9. The samples for analysis of glipizide will be collected on study days -1 and 6.)
- Pharmacodynamic variables: 24 h plasma glucose, Insulin(Samples for 24-hour plasma glucose and insulin will be collected on study days -1, 6 and 9.)
研究者
研究点 (1)
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