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临床试验/CTRI/2016/09/007312
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

发起方
ovo Nordisk India Private Ltd

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