NCT01020123已完成2 期
A 4-month, Randomized, Double-blind, Placebo- and Active-Controlled, Multi-centre, Parallel-Group Study, With an Optional 2-month Extension, to Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in 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
- 530
- 试验地点
- 1
- 主要终点
- HbA1c: Change From Baseline to 4 Month
研究概览
简要总结
The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in TD2M Patients
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female of non-childbearing potential
- •Treated with maximally tolerated dose of metformin (≥ 1500mg/day) for at least 10 weeks prior to enrolment.
- •Patients with HbA1c ≥ 7.5 but ≤ 10% at enrolment visit (Visit 1) can enter cohort 1.Patients with HbA1c between >10 % and <12 % can enter the open-label arm with AZD1656 (cohort 2)
排除标准
- •Significant cardiovascular event within the last 6 months prior to enrolment or heart failure New York Heart Association (NYHA) class III-IV.
- •Impaired renal function in terms of GFR<60 ml/min, based on Modification of Diet in Renal Disease Study Group (MDRD) calculation.
- •Use of warfarin or amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and/or macrolide antibiotics within 14 days before randomisation.
研究组 & 干预措施
1
Experimental
AZD1656
干预措施: AZD1656 (Drug)
2
Experimental
AZD1656
干预措施: AZD1656 (Drug)
3
Experimental
AZD1656
干预措施: AZD1656 (Drug)
4
Experimental
AZD1656
干预措施: AZD1656 (Drug)
5
Experimental
AZD1656
干预措施: AZD1656 (Drug)
6
Placebo Comparator
干预措施: Placebo (Drug)
7
Active Comparator
Glipizide administered to 1 group of patients
干预措施: Glipizide (Drug)
结局指标
主要结局
HbA1c: Change From Baseline to 4 Month
时间窗: Baseline to 4th Month
AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue
次要结局
- OGTT/Insulin(baseline to 4 month)
- FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.(baseline to 4 month)
- SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.(baseline to 4 month)
- OGTT/Plasma Glucose(baseline to 4 month)
- OGTT/C-peptide(baseline to 4 month)
- OGTT/Pro-insulin/Insulin(baseline to 4 month)
- HbA1c ≤ 7(baseline to 4 month)
- HbA1c ≤ 6.5(baseline to 4 month)
- LDL-C: Mean Ratio(baseline to 4 month)
- HDL-C: Change From Baseline(baseline to 4 month)
- Total Cholesterol: Change From Baseline(baseline to 4 month)
- Triglycerides: Change From Baseline(baseline to 4 month)
- C-reactive Protein: Change From Baseline(baseline to 4 month)
- Systolic Blood Pressure, Change From Baseline(baseline to 4 month)
- Diastolic Blood Pressure, Change From Baseline(baseline to 4 month)
- Pulse, Change From Baseline(baseline to 4 month)
- Weight, Change From Baseline(baseline to 4 month)
- QTcF; Electorcardiagram Change From Baseline(baseline to 4 month)
- Haemoglobin; Change From Baseline(baseline to 4 month)
- Leukocytes; Change From Baseline(baseline to 4 month)
- Sodium; Change From Baseline(baseline to 4 month)
- Potassium; Change From Baseline(baseline to 4 month)
- Creatinine; Change From Baseline(baseline to 4 month)
- ALT; Change From Baseline(baseline to 4 month)
- AST; Change From Baseline(baseline to 4 month)
- Alkaline Phosphatase; Change From Baseline(baseline to 4 month)
- Bilirubin; Change From Baseline(baseline to 4 month)
- CL/F to Characterise the PK Properties of AZD1656.(at 4 month)
- EC50 to Characterise the PD Properties of AZD1656.(at 4 month)
研究者
研究点 (1)
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