NCT00817271已完成1 期
A Randomised, Open, Two-Way Cross-Over, Phase I Study to Evaluate the Response to Glucagon Versus the Spontaneous Counter-Regulatory Response in T2DM Patients Treated With AZD1656 and Metformin During Hypoglycemia
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
- 8
- 试验地点
- 1
- 主要终点
- P-Glucose levels
研究概览
简要总结
The purpose of this study is to evaluate the response to Glucagon versus the spontaneous hormonal response to low blood sugar levels in T2DM Patients treated with AZD1656 and Metformin
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
- None
入排标准
- 年龄范围
- 18 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
- •T2DM diagnosis confirmed by C-peptide >0.3nmol/L and no glutamic acid decarboxylate (GAD) antibodies at enrolment (screening)
- •Treatment with metformin alone with a total daily dose not less than 1 000 mg. Stable glycaemic control indicated by unchanged treatment within 3 months prior to enrolment
排除标准
- •History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
- •Signs of diabetic proliferative retinopathy or diabetic maculopathy, at screening or on an ophthalmological examination within 3 months from start of study
- •Participating in another clinical study during the last 30 days prior to enrolment
研究组 & 干预措施
1
Experimental
干预措施: AZD1656 (Drug)
1
Experimental
干预措施: Glucagon (Drug)
2
Experimental
干预措施: AZD1656 (Drug)
结局指标
主要结局
P-Glucose levels
时间窗: Repeated sampling during the 24 hour period on day 5 and 8
次要结局
- Safety and tolerability (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)(Frequent measurements during the study period)
- Pharmacokinetic variables (Area under the plasma conc-time curve from time 0 to 24 hours post dose (AUC0-24), maximum plasma conc(Cmax), time to reach maximum plasma conc(tmax), terminal elimination half-life and apparent oral clearance(Repeated sampling during the 24 hour period on day 5 and 8)
- Pharmacodynamics (P-Glucose, S-Insulin and S-C-peptide)(Repeated sampling during the 24 hour period on day 5 and 8)
研究者
研究点 (1)
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