NCT01608724已完成4 期
A Multicenter, Single Arm, Cohort Study to Evaluate the Efficacy and Safety of Saxagliptin 5mg, Once Daily for 24 Weeks, in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,165
- 试验地点
- 1
- 主要终点
- Absolute Change From Baseline in Haemoglobin A1c (HbA1c)
研究概览
简要总结
The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.
详细描述
A multicenter, single arm, cohort study to evaluate the Efficacy and Safety of saxagliptin 5mg, once daily for 24 weeks, in patients with type 2 diabetes mellitus who are treatment naive or who have inadequate glycaemic control on metformin alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures Diagnosed with type 2 diabetes
- •Men or women who are >18 years of age at time of consenting upon Visit 1
- •HbA1c >7.5% and ≤11.0% Patients should be drug naive or treated with metformin alone on stable doses of for at least continues 8 weeks prior to Visit 1
- •Drug naive patients are defined as patients who have not received medical treatment for diabetes (insulin and/or oral hypo)
排除标准
- •Pregnant or breastfeeding patients
- •Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
- •Previous treatment with any DPP-IV inhibitors or GLP-1 analogue
- •History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD)
- •Treatment with systemic glucocorticoids other than replacement therapy
- •Inhaled, local injected and topical use of glucocorticoids is allowed
研究组 & 干预措施
Open label
Experimental
Saxagliptin, oral 5mg once a day(Q. D.)
干预措施: Saxagliptin (Drug)
结局指标
主要结局
Absolute Change From Baseline in Haemoglobin A1c (HbA1c)
时间窗: Weeks 6, 12, and 24
Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise.
次要结局
- Proportion (%) of Patients Achieving HbA1c <7%(Weeks 6, 12, and 24)
- Change From Baseline in Fasting Plasma Glucose (FPG)(Weeks 6, 12, 18, and 24)
- Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)(Week 24)
研究者
研究点 (1)
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