A 52-week extension to a multicenter, randomized, double-blind, active controlled study to compare the effect of 52 weeks treatment with LAF237 50 mg bid to metformin up to 1000 mg bid in drug naïve patients with type 2 diabetes
- Conditions
- Type II Diabetes
- Registration Number
- EUCTR2004-002136-25-GB
- Lead Sponsor
- ovartis Pharmaceuticals UK Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 530
Inclusion Criteria
1.Written informed consent to participate in the extension study.
2.Ability to comply with all study requirements.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1.Premature discontinuation from the core study.
2.Concomitant medical conditions that interfere with the interpretation of study results as defined in the core protocol.
3.Failure to comply with the core study protocol.
4.Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method