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临床试验/CTRI/2012/11/003109
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

发起方
ovartis HealthCare private Limited

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