This surveillance is a postmarketing commitment following the marketing authorization for Forxiga(dapagliflozin) in accordance with Standards on Re-examination of New Drugs, notified by the MFDS under Article 32, Paragraph 1 and Article 37, Paragraph 3 of Pharmaceutical Affairs Law. MFDS requires that at least 3,000 patients who can be evaluated for safety assessment should be collected within 6 years from 26 Nov 2013 to 25 Nov 2019.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 years and older
* Patients with T2DM eligible for treatment with Forxiga as indicated in the locally approved prescribing information
* Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria:
* Patients treated with Forxiga outside of the locally approved label in Korea
* Patients with contraindications for the use of Forxiga (as described in the Korean product label)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number and incidence rate of adverse events and serious adverse event including unexpected adverse drug reactions
Timeframe: Adverse event will be collected from baseline(Day1) to 3 days after 12 weeks (maximum 16 weeks) or 24 weeks (maximum 30 weeks))