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Safety Of DAPAGLIFLOZIN (FORXIGA) in Patient With Type 2 Diabetes Mellitus (T2dm) In Vietnam From A Post-Marketing Surveillance Program

NCT07210307 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1001

Last updated 2025-10-07

No results posted yet for this study

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 from its date of approval. For the case of the study treatment (dapagliflozin - Forxiga), safety and drug utilization reports have been regularly submitted by AstraZeneca to DAV every 6 months since its date of approval on 25th May 2016. To provide additional evidence on the safety profile of dapagliflozin in real-life settings and support renewing marketing authorizations for Forxiga, AstraZeneca collaborated with eight hospitals across Vietnam to implement this study.

Conditions

  • Safety Outcomes

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2020-03-17
Completion
2020-03-17

Countries

  • Vietnam

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07210307 on ClinicalTrials.gov