A Randomised, Single-Blind, Placebo-Controlled, Phase IIa Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 During Four Weeks in T2DM Subjects Treated With Insulin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pulse, 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 Insulin
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
- •type II diabetes patients, female with non child-bearing potential
- •Subjects with T2DM diagnosis for at least one year, treated with insulin alone or insulin in combination with other anti-diabetic drugs. Subjects must have been treated with insulin the last 3 months prior to enrolment (screening)
- •HbA1c <11% at enrolment (screening) (HbA1c value according to international Diabetes Control and Complications Trial [DCCT] standard).
- •FPG in the range of 7.0 to 13.0 mmol/L (126 to 234 mg/dL)
排除标准
- •History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
- •Use of glitazones, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and macrolide antibiotics within 14 days before randomisation.
- •Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patients' safety or successful participation in the clinical study.
研究组 & 干预措施
1
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)
2
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)
结局指标
主要结局
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
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
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 following the morning dose last day of treatment)
- Time to Reach Maximum Plasma Concentration 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)
- Terminal Elimination Half-life of AZD1656(Measured following the evening dose last day of treatment)
- Apparent Oral Clearance of AZD1656(Measured last day of treatment)