A Randomised, Single-Blind, Placebo-Controlled, Phase IIA Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure, Change From Baseline to End of Treatment
研究概览
简要总结
The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 women of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation)
- •Ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8 weeks prior to randomisation
- •HbA1c ≤ 10% at enrolment (HbA1c value according to international Diabetes Control and Complications Trial [DCCT] standard)
排除标准
- •History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
- •Clinically significant abnormalities in ECG, clinical chemistry, haematology, or urine analysis results. Positive test for Hepatitis B surface antigen or antibodies to human immunodeficiency virus (HIV) or antibodies to Hepatitis C virus
研究组 & 干预措施
Placebo
Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
干预措施: Placebo (Drug)
AZD1656
Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
干预措施: AZD1656 (Drug)
结局指标
主要结局
Systolic Blood Pressure, Change From Baseline to End of Treatment
时间窗: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Diastolic Blood Pressure, Change From Baseline to End of Treatment
时间窗: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Pulse, Change From Baseline to End of Treatment
时间窗: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Weight, Change From Baseline to End of Treatment
时间窗: Baseline is the day before first dose, end of treatment is last day of treatment
Clinically Relevant Change of Laboratory Variables
时间窗: Measured regularly from day before first dose to day after last dose
Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters
次要结局
- Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656(Measured last day of treatment)
- Maximum Plasma Concentration of AZD1656(Measured last day of treatment)
- Time to Reach Maximum Plasma Concentration of AZD1656(Measured last day of treatment)
- Terminal Elimination Half-life of AZD1656(Measured following the afternoon dose last day of treatment)
- Apparent Oral Clearance of AZD1656(Measured last day of treatment)
- P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment(Baseline is the day before first dose, end of treatment is last day of treatment)
- S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment(Baseline is the day before first dose, end of treatment is last day of treatment)
- S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment(Baseline is the day before first dose, end of treatment is last day of treatment)