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. A 104-week randomised, phase 4, two-arm, open-label, active-controlled, multicentre, multinational, parallel-group trial. - LIRA-PRIME

ovo Nordisk A/S0 个研究点目标入组 1,994 人开始时间: 2015年11月11日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•1. Male or female = 18 years of age at the time of signing informed consent.
•2. Subjects diagnosed (clinically) with type 2 diabetes = 90 days prior to the screening visit.
•3. Stable daily dose of metformin as monotherapy = 1500 mg or maximum tolerated dose within 60 days prior to the screening visit.
•4. HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior to the screening visit.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1694
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 300

•1. 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).
•2. Receipt of any investigational medicinal product within 30 days before the screening visit.
•3. 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.
•4. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.

发起方