CTRI/2016/09/007312已完成4 期
IRA-PRIME: Efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin vs. OADs as add-on to metformin after up to 104 weeks of treatment in subjects with type 2 diabetes inadequately controlled with metformin monotherapy and treated in a primary care setting - LIRA-PRIME
ovo Nordisk India Private Ltd0 个研究点目标入组 207 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
- 207
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
- •1. Male or female >= 18 years of age limit of signing informed consent. 2. Subjects diagnosed(clinically) with type 2 diabetes >= 90 days prior to screening visit. 3. Stable daily dose of metformin as a monotherapy >= 1500mg or maximum tolerated dose within 60 days prior to screening visit. 4. HbA1C 7.5-9.0%(59-75mmol/mol)(both inclusive ) and measured within the last 90 days prior to screening visit.
排除标准
- •1. Previous participation in this trial. Participation is defined as signed informed consent.
- •2. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
- •potential and not using adequate contraceptive methods (adequate contraceptive measures as
- •required by local regulation or practice).
- •3. Receipt of any investigational medicinal product within 30 days before the screening visit.
- •4. Treatment with any medication for the indication of diabetes other than metformin in a period of 60 days before the screening visit. An exception is short-term treatment (<=7 days in total) with insulin in connection with intercurrent illness.
- •5. Any disorder, which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or
- •compliance with the protocol.
研究者
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