CTRI/2010/091/001258
Completed
Phase 4
An observational, multinational, multi-center, prospective, open-label study to asses effectiveness, safety and tolerability of treatment with vildagliptin or vildagliptin plus metformin (SPC) in type 2 diabetes mellitus patients in a real-world setting - GUARD
ovartis Healthcare Pvt LtdSandoz house Dr ABRoad WorliMumbai0 sites20,000 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Healthcare Pvt LtdSandoz house Dr ABRoad WorliMumbai
- Enrollment
- 20000
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? Male or female outpatients (age \&\#8805; 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
Outcomes
Primary Outcomes
Not specified
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