NCT01409213已完成不适用
Standardized Non-interventional Register Investigating the Daily Clinical Practice for the Treatment of Patients With Diabetes Mellitus Type 2 (SIRTA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,523
- 主要终点
- Change From Baseline for Mean Fasting Blood Glucose (FBG)
研究概览
简要总结
The purpose of this study is to collect information of the risk profile of patients with type 2 diabetes mellitus, their treatment concerning meeting the guidelines for treatment of diabetic patients type 2 published by the Deutsche Diabetes Gesellschaft (DDG) on October 13, 2008
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Newly diagnosed with Type 2 diabetes in whom treatment with metformin in
- •the individual maximal tolerated dose (at least four weeks on stable dose) resulted in
- •HbA1c >6.5%
- •No contraindication or intolerability to metformin
排除标准
- •Currently being administered a combination therapy for the treatment of their Type 2 diabetes
结局指标
主要结局
Change From Baseline for Mean Fasting Blood Glucose (FBG)
时间窗: Baseline and end of Observation (up to Month 6)
Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value.
Change From Baseline for Mean Hemoglobin A1c (HbA1C)
时间窗: Baseline and end of Observation (up to Month 6)
Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value.
次要结局
未报告次要终点
研究者
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