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临床试验/CTRI/2015/05/005821
CTRI/2015/05/005821Other4 期

A double blind, double dummy, randomised, multi-centrestudy to assess the tolerability and efficacy profile ofvildagliptin compared to gliclazide as dual therapy withmetformin in Muslim patients with type 2 diabetes fastingduring Ramadan - STEADFAST

ovartis Healthcare Private Limited0 个研究点目标入组 552 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
Other
发起方
入组人数
552

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Confirmed Type 2 Diabetes diagnosis
  • Plan to fast during Ramadan
  • Treated with a combination of metformin and an Sulfonylurea (SU) for at least 12 weeks and HbA1c <=8.5% at Visit 1
  • Taking a sulfonylurea treatment for less than 3 years prior to Visit 1
  • Body mass index (BMI) >=22 and <=45 kg/m2 at Visit 1

排除标准

  • Pregnant or nursing (lactating) women
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
  • Patients who are taking any other anti-diabetes drug (oral or injection) other than metformin and an SU component.
  • Inability to comply with the study procedures or medications.

研究者

发起方
ovartis Healthcare Private Limited

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