GUARD (GalvUs: A Real WorlD clinical use)
Phase 4
Completed
- Registration Number
- CTRI/2010/091/001258
- Lead Sponsor
- ovartis Healthcare Pvt LtdSandoz house Dr ABRoad WorliMumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20000
Inclusion Criteria
? Male or female outpatients (age ≥ 18 years) with a diagnosis of T2DM who have, within the previous 4 weeks, been prescribed vildagliptin on top of metformin therapy (free dose combination or SPC) or (only if approved in the relevant country) are OAD drug naïve patients who have been prescribed vildagliptin as initial monotherapy.
? Patients who consent to have their data collected. Patients will not need to consent to taking the drug, as their treatment is decided before entry into the study and is part of their medical care
Exclusion Criteria
Patients with an HbA1c value greater than 10%Contraindications mentioned in the Summary of Product Characteristics for vildagliptin, metformin and vildagliptin plus metformin SPC
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the percent change from baseline (BL) in HbA1c after 24 weeks treatment with vildagliptin as monotherapy or in addition to metformin or vildagliptin plus metformin (SPC) in adult T2DM patientsTimepoint: after 24 weeks
- Secondary Outcome Measures
Name Time Method