Status:
COMPLETED
Safety Of DAPAGLIFLOZIN (FORXIGA) in Patient With Type 2 Diabetes Mellitus (T2dm) In Vietnam From A Post-Marketing Surveillance Program
Lead Sponsor:
AstraZeneca
Conditions:
Safety Outcomes
Eligibility:
All Genders
18+ years
Brief Summary
This study is conducted to meet the requirements of the Drug Administration of Vietnam (DAV) on conducting necessary safety evaluations in routine clinical practice for a new medication within 3 years...
Detailed Description
This study is a longitudinal observation on a cohort of 1001 patients with type 2 diabetes mellitus (T2DM), newly treated with dapagliflozin at eight hospitals across Vietnam. Adult T2DM patients who ...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 years)
- Diagnosed with T2DM, and eligible for initiating treatment with dapagliflozin according to indications of the approved summary of product characteristics of Forxiga in Vietnam.
- Provision of signed and dated written informed consent form by the potential study subject or the subject's legal guardian to demonstrate that s/he was informed necessary information of this study, prior to any mandatory study specific procedures
Exclusion
- Patients who were prescribed dapaglifozin for off-label use (not mentioned in the approved summary of product characteristics of Forxiga in Vietnam)
- Patients who had contraindications with Forxiga
Key Trial Info
Start Date :
October 31 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 17 2020
Estimated Enrollment :
1001 Patients enrolled
Trial Details
Trial ID
NCT07210307
Start Date
October 31 2017
End Date
March 17 2020
Last Update
October 7 2025
Active Locations (1)
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1
HCMC Heart Institute
Ho Chi Minh City, Vietnam