NCT04132934已完成不适用
Observational Study Program Assessing Effectiveness and Tolerability of Gliclazide MR 60mg in Patients With Type 2 Diabetes Fasting During RAMADAN
Servier Affaires Médicales1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2019年3月11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
- 1,200
- 试验地点
- 1
- 主要终点
- Proportion of patients with at least one Hypoglycemia event
研究概览
简要总结
The purpose of this observational study is to assess effectiveness and tolerability of gliclazide MR 60mg during RAMADAN in a real world setting in 9 countries from Asia Pacific and Middle East/North Africa
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
- •Informed consent obtained before any trial-related activities
- •Male or female type 2 diabetic patients aged >18 years
- •Patients with controlled or suboptimal controlled type 2 diabetes
- •Patients with experience in SMBG controlling using glucometer
- •Patients who are willing to fast during Ramadan
- •Patients already treated with Gliclazide MR 60mg
排除标准
- •Insulin therapy requirement
- •Severe liver or renal failure
- •HbA1c ≥ 9%
- •Contraindication to gliclazide according to SmPC
- •Pregnancy or breast feeding
- •Previous experience of severe or repeated hypoglycemia events without triggered factor within the previous year
结局指标
主要结局
Proportion of patients with at least one Hypoglycemia event
时间窗: up to 5 months
次要结局
未报告次要终点
研究者
研究点 (1)
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