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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

CompletedN/A

Sponsor: AstraZeneca

Conditions: Safety Outcomes

Countries: Vietnam

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Locations (1)

Ho Chi Minh City, Vietnam