HCMC Heart Institute
Ho Chi Minh City, Vietnam
Completed
NCT Number: NCT07210307
Safety Of DAPAGLIFLOZIN (FORXIGA) in Patient With Type 2 Diabetes Mellitus (T2dm) In Vietnam From A Post-Marketing Surveillance Program
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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 were newly treated with dapagliflozin and signed the informed consent form were eligibly recruited. For each recruited subject, the maximum duration of observation was 24 weeks, divided into 4 visits. In the first visit, data on subjects' baseline characteristics was collected. In the later visits, the presence, and the patterns of adverse events during the time treated with dapagliflozin were investigated.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Annual incidence rate and proportions of AE, SAE, and sAR within 24 weeks
Time frame: 24 weeks
Monitoring and reporting data on adverse events (AEs) and serious adverse events (SAEs) during the treatment with dapagliflozin was implemented consistently with routine care in each studied site. For the patients discontinued dapagliflozin before completing the standard follow-up period (24 weeks), data would be collected via phone calls or emails. Decisions of continuing or discontinuing dapagliflozin treatment, either related or unrelated with safety issues, were completely depended on the medical doctor's opinion, with the patient's agreement
Sponsors and collaborators
Lead sponsor
AstraZeneca
Industry
Registry information
Official study title
Forxiga (Dapagliflozin) Regulatory Post Marketing Surveillance
Acronym: DAPAPMS
Important dates
- Study start
- 2017
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Oct 7, 2025
- Registry last updated
- Oct 7, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.