NCT00819884已完成1 期
A Randomised, Two Way Cross-Over, Single-Blind, Phase I Study to Evaluate 24-hr Glucose Profiles in Patients With T2DM When Dosed OD and BD on Top of Metformin for Four Days With AZD1656
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
- 24-hr glucose (Calculated plasma glucose AUC0-24, change in fasting plasma glucose)
研究概览
简要总结
The purpose of this study is to compare the 24-hour glucose profiles in diabetic patients treated with metformin following once daily and twice daily oral dosing
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type II diabetes patients, female with non child-bearing potential
- •Type 2 Diabetes Mellitus (T2DM) diagnosis confirmed by C-peptide >0.3nmol/L and no Glutamic acid decarboxylase (GAD) antibodies at enrolment (screening)
- •Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrolment and the metformin dose must have been unchanged during this period
排除标准
- •History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
- •Any clinically significant abnormality identified on physical examination, laboratory test or ECG, which in the judgement of investigator would compromise the subject's safety or successful participation in the clinical study
研究组 & 干预措施
1
Experimental
twice daily during 4 days
干预措施: AZD1656 (Drug)
2
Experimental
once daily during 4 days
干预措施: AZD1656 (Drug)
结局指标
主要结局
24-hr glucose (Calculated plasma glucose AUC0-24, change in fasting plasma glucose)
时间窗: Repeated sampling during the 24 hour period on day -1, 4 and 8
次要结局
- Pharmacodynamics (S-Insulin AUC0-24 and C-peptide AUC0-24)(Repeated sampling during the 24 hour period on day -1, 4 and 8)
- Safety and tolerability (Adverse events (AEs) during the study, blood pressure (BP), pulse rate, safety laboratory variables (incl. glucose) and investigator's interpretation of electrocardiogram (ECG)(Frequent measurements during the study period)
- Pharmacokinetic variables (Area under the plasma conc vs. time curve (AUC0-24), maximum plasma conc (Cmax), time to reach maximum plasma conc(tmax), terminal elimination half-life and apparent oral clearance(Repeated sampling at pre-specified timepoints on day 4 and 8)
研究者
研究点 (1)
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