A multi-centre study to assess tolerabilty and efficacy of the vildagliptin plus metformin versus gliclazide plus metformin inMuslim patients with Type 2 diabetes fasting during Ramada
Phase 4
- Conditions
- Health Condition 1: E08-E13- Diabetes mellitusHealth Condition 2: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2015/05/005821
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 552
Inclusion Criteria
•Confirmed Type 2 Diabetes diagnosis
•Plan to fast during Ramadan
•Treated with a combination of metformin and an Sulfonylurea (SU) for at least 12 weeks and HbA1c <=8.5% at Visit 1
•Taking a sulfonylurea treatment for less than 3 years prior to Visit 1
•Body mass index (BMI) >=22 and <=45 kg/m2 at Visit 1
Exclusion Criteria
•Pregnant or nursing (lactating) women
•History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
•Patients who are taking any other anti-diabetes drug (oral or injection) other than metformin and an SU component.
•Inability to comply with the study procedures or medications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method