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Forxiga safety under the microscope: Real-World data from 1,000 patients

NCT ID NCT07210307

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracked over 1,000 adults with type 2 diabetes in Vietnam who were prescribed dapagliflozin (Forxiga) as part of routine care. Researchers monitored side effects and serious events over 24 weeks to confirm the drug's safety in real-world use. The goal was to support the drug's continued approval in Vietnam.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapagliflozin (Forxiga)

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,001 people

The number who actually took part.

Started

Oct 2017

Finished

Mar 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The cohort of interest included 1001 adult patients with T2DM who were newly treated with dapagliflozin (Forxiga). The sample size was determined in compliance with Vietnamese Ministry of Health's guidelines on conducting phase 4 clinical research to assess clinical benefits and risks of a medicinal product in real-life settings (8). According to this guideline, the minimal sample size for such a study is 1000 subjects. To achieve this targeted sample size, the total study period was expectedly 3 years.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Safety outcomes

Contacts and locations

Locations

  • HCMC Heart Institute

    Ho Chi Minh City, Vietnam

More trials for these conditions

Other studies related to the condition(s) this trial covers.