NCT01152385已完成2 期
A 4-month Treatment, Randomized, Double-blind, Placebo-Controlled, Multi-centre, Parallel-Group Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of Different Dosing Regimens of AZD1656 as Monotherapy in Japanese Type 2 Diabetes Mellitus Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Change in Haemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to compare the effect on glucose control of 3 different AZD1656 dosing regimens with placebo in Japanese type 2 diabetes mellitus (T2DM) patients, as evaluated by the change in HbA1c from baseline to the end of treatment at 4 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •women of non-childbearing potential.
- •Provision of informed consent prior to any study specific procedures
- •Naïve T2DM patients with HbA1c ≥ 7.5% but ≤ 10% or T2DM Patients treated with one or two oral anti-hyperglycaemic agent(s) with HbA1c ≥ 7.5% but ≤ 9.5% at enrolment visit (Visit1)
排除标准
- •Clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, hepatic disease and haematological disease.
- •The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
- •Participation in another clinical trial and/or intake of another investigational drug within the last 30 days prior to enrolment visit
研究组 & 干预措施
high
Experimental
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
干预措施: AZD1656 (Drug)
Middle
Experimental
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
干预措施: AZD1656 (Drug)
low
Experimental
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
干预措施: AZD1656 (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Haemoglobin A1c (HbA1c)
时间窗: from baseline to 4 months
次要结局
- Change in Fasting Plasma Glucose (FPG)(from baseline to 4 months)
- Number of Responders in Terms of HbA1C ≤ 7%(at 4th month)
- Number of Responders in Terms of HbA1C ≤ 6.5%(at 4th month)
- Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)(from baseline to 4 months)
- Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)(from baseline to 4 months)
- Percentage Change in Triglycerides(from baseline to 4 months)
- Change in High-sensitivity C-reactive Protein (Hs-CRP)(from baseline to 4 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 DiabetesDiabetes Mellitus, Type 2NCT04556760AstraZeneca46
已完成
1 期
Investigate the Effect of AZD1656 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Type 2 Diabetes Mellitus (T2DM) PatientsType 2 Diabetes MellitusNCT01103609AstraZeneca16
已完成
1 期
Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus PatientsType 2 Diabetes MellitusNCT01103622AstraZeneca20
已完成
1 期
A Study to Evaluate P-Glucose, Safety and Tolerability After Oral Single Dosing of AZD6370 in Type 2 Diabetic PatientsType 2 DiabetesNCT00690287AstraZeneca24
已完成
1 期
AZD9056 Relative Bioavailability StudyHealthyNCT00908934AstraZeneca24