NCT06704802已完成不适用
Observational Cohort Study Evaluating the Effectiveness of an Education Program (NGAYDAUTIEN) in Combination With Gliclazide MR in the Management of Uncontrolled Type 2 Diabetic Patients.
Servier Affaires Médicales1 个研究点 分布在 1 个国家目标入组 678 人开始时间: 2022年11月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 678
- 试验地点
- 1
- 主要终点
- change of HbA1c level (measured in %) from baseline after a 6-month follow-up among the 2 arms
研究概览
简要总结
The primary objective is to assess the change of HbA1c level from baseline after a 6-month follow up among uncontrolled patients with T2D who will be initiated to Diamicron® MR 60 (originator product) plus an educational program (NGAYDAUTIEN) as monotherapy or in add on to metformin in comparison to an initiation of an Oral Antidiabetic Drug (OAD) (except Diamicron®) as monotherapy or in add on to metformin.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Aged at least 18 years (without upper limit of age)
- •HbA1c value is required at the baseline visit
- •Patients with diagnosis of uncontrolled T2D
- •Initiation of a new OAD as monotherapy or on top of metformin
- •Patient follow-up within the scope of the current medical practice and in the same health center during the 6-month period.
排除标准
- •Diagnosis of diabetes other than T2D
- •HbA1c value not available at baseline
- •Patients who previously attended to the NDT educational program for T2D management
- •Required at baseline an insulin therapy according to national guideline
- •Used any other OAD (except metformin)
- •Used a single pill combination in addition to the medicine of interest
- •Have a severe disease (i.e. cirrhosis, end stage renal disease...)
- •Are unlikely to cooperate in the study or to follow the educational program
结局指标
主要结局
change of HbA1c level (measured in %) from baseline after a 6-month follow-up among the 2 arms
时间窗: from baseline to 6-month follow-up
次要结局
未报告次要终点
研究者
研究点 (1)
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