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
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