NCT00745433已完成不适用
REPAMET 2: Observational Study of the Switch From Metformin Monotherapy to Bitherapy With Metformin and Repaglinide
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 906
- 主要终点
- HbA1c
研究概览
简要总结
This study is conducted in Europe. The aim of this observational study is to investigate the efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Type 2 diabetes
- •Metformin monotreatment
- •HbA1c greater than 7%
- •Treatment according to SPC
- •Informed consent obtained
排除标准
- •Any contraindication to the use of repaglinide (according to the SPC)
研究组 & 干预措施
A
Repaglinide add-on to metformin.
干预措施: metformin (Drug)
A
Repaglinide add-on to metformin.
干预措施: repaglinide (Drug)
结局指标
主要结局
HbA1c
时间窗: After 12-20 weeks.
次要结局
- PPG(After 12-20 weeks.)
- Number of hypoglycemic events(After 12-20 weeks.)
- Variability in FPG (Fasting Plasma Glucose)(After 12-20 weeks.)
研究者
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