NCT02367066已完成1 期
A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX After Administration of Repeated Doses for 3 Days in Subjects With Type 2 Diabetes Mellitus
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
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose
研究概览
简要总结
A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus
详细描述
A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •History or sign of any clinically significant disease or disorder which, in the opinion f the investigator, may either put the subject at risk because of participation in the sudy, or influence the results or the subject's ability to participate in the study
- •Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory results >3x upper level of normal range (ULN) Clinical diagnosis of Type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase Autoantibodies test (GAD antibodies test).
- •Patients treated with single Insulin therapy within the last 3 months
研究组 & 干预措施
AR-C165395XX + placebo
Experimental
1st period AR-C165395XX 2nd period placebo
干预措施: AR-C165395XX (Drug)
Placebo + AR-C165395XX
Placebo Comparator
1st period Placebo for AR-C165395XX 2nd period AR-C165395XX
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose
时间窗: Day -1 to Day 3 and Day 6 to Day 9
MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve
Change From Baseline to Endpoint MMTT C_max for Plasma Glucose
时间窗: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide
时间窗: Day -1 to Day 3 and Day 6 to Day 9
GGI=Glucose and GLP1 infusion AUC=Area Under Curve
次要结局
- Time of Maximum Plasma AZD1081 Concentration, t_ss,Max(Days 2,3,8,9)
- Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin(Day -1 to Day 3 and Day 6 to Day 9)
- Plasma AZD1981 AUC(0-1h)(Days 2,3,8,9)
- Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon(Day -1 to Day 3 and Day 6 to Day 9)
- Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide(Day -1 to Day 3 and Day 6 to Day 9)
- Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin(Day -1 to Day 3 and Day 6 to Day 9)
- Plasma AZD1981 AUC(0-2h)(Days 2,3,8,9)
- Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin(Day -1 to Day 3 and Day 6 to Day 9)
- Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon(Day -1 to Day 3 and Day 6 to Day 9)
- Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon(Day -1 to Day 3 and Day 6 to Day 9)
- Change From Baseline to Endpoint Fasting Beta-cell Responsiveness(Day -1 to Day 3 and Day 6 to Day 9)
- Fasting Insulin at Endpoint(Day 3 and Day 9)
- Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max(Days 2,3,8,9)
- Plasma AZD1981 AUC(1-2h)(Days 2,3,8,9)
- Plasma Paracetamol Maximum Concentration, C_max(Days 3,9)
- Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min(Days 2,3,8,9)
- Time of Maximum Plasma Paracetamol Concentration, t_max(Days 3,9)
- Plasma Paracetamol AUC(0-t)(Days 3,9)
- Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide(Day -1 to Day 3 and Day 6 to Day 9)
- Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose(Day -1 to Day 3 and Day 6 to Day 9)
- Plasma AZD1981 AUC(0-4h)(Days 2,3,8,9)
- Plasma AZD1981 AUC(0-12h)(Days 2,3,8,9)
- Plasma AZD1981 AUC(0-24h)(Days 2,3,8,9)
- Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F(Days 2,3,8,9)
研究者
研究点 (1)
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