IRA-PRIME: A trial comparing the time period with blood sugar control using Victoza® (liraglutide) vs. oral antidiabetic treatment for up to 104 weeks of treatment in subjects with type 2 diabetes in a primary care setting
- Conditions
- Health Condition 1: E08-E13- Diabetes mellitusHealth Condition 2: null- Type 2 Diabetes mellitus
- Registration Number
- CTRI/2016/09/007312
- Lead Sponsor
- ovo Nordisk India Private Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 207
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method