CTRI/2012/11/003109已完成4 期
A multicentre, prospective, observational cohort study to assess the effects of vildagliptin relative to sulphonylurea as dual therapy with metformin (or as monotherapy*) in Muslim patients with type 2 diabetes fasting during Ramadanâ?? - VIRTUE
ovartis HealthCare private Limited0 个研究点目标入组 1,000 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •The study includes patients who meet the following criteria:
- •1.Give written informed consent before any data is collected
- •2.18 years of age or older
- •3.Diagnosed with T2DM at least 12 months prior to the start of Ramadan fasting
- •4.Treated, for at least 4 weeks but not more than 3 years before fasting commences, with either vildagliptin as dual therapy with metformin (or vildagliptin as monotherapy) OR sulphonylurea as dual therapy with metformin (or sulphonylurea as monotherapy)
- •5.Plan to fast during Ramadan
- •6.Have HbA1c <= 8.5% (as measured within 6 weeks prior to entry into the study)
排除标准
- •1.Contraindications appearing in the local approved prescribing information for the prescribed medication
- •2.Use of any investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment, whichever is longer
- •3.Patients who require three or more oral anti-diabetes therapies at time of study entry
- •4.Patients who are using insulin at the time of study entry.
研究者
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