A clinical study to Evaluate the Safety and Efficacy of FDC containing Orlistat and Metformin with Metformin alone in Obese Type II Diabetic Patients.
- Conditions
- Health Condition 1: null- Obese patients with Type II diabetes
- Registration Number
- CTRI/2012/01/002334
- Lead Sponsor
- Biocon Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
i) Male and female patients in the age group of 20-80 years
ii) Females of childbearing potential should have a negative pregnancy test at the pre-study visit and agree to use contraception during the study.
iii) Patients willing to give informed consent.
iv) Mild to moderate obese Type 2 diabetic patient.
v) Patients who are willing to comply with all study requirements
i) Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the required by the protocol visits).
ii) Patients who are currently participating or had participated in other interventional study for last 3 months prior to their enrolment.
iii) Women who are pregnant, breast feeding or have the intention of becoming pregnant during their participation in the study.
iv) Women of childbearing potential who are not using effective and medically acceptable methods of contraception.
v) Patients who are meeting any of the contraindications of the study medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method