A 28-week extension to a multicenter, randomized, double-blind, active controlled study to compare the effect of 24 weeks treatment with LAF237 50 mg bid to rosiglitazone 8 mg qd in drug naïve patients with type 2 diabetesExtensión de 28 semanas del estudio multicéntrico, aleatorizado, doble ciego, con control activo que compara el efecto de 24 semanas de tratamiento con 50 mg bid de LAF237 frente a 8 mg qd de rosiglitazona en pacientes naive con diabetes Tipo 2.
- Conditions
- Diabetes Mellitus II
- Registration Number
- EUCTR2004-002644-10-ES
- Lead Sponsor
- ovartis Farmaceutica S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 660
Written informed consent to participate in the extension study.
Ability to comply with all study requirements.
Details of inclusion and exclusion into the core study can be found in the core protocol
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
Premature discontinuation from the core study.
Concomitant medical conditions that interfere with the interpretation of study results as defined in the core protocol.
Failure to comply with the core study protocol.
Any patients that the primary investigator decides should not participate in the extension 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