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NCT02252224

Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance

Completed Last updated 16 March 2020
What this trial tests

trial in Type 2 Diabetes Mellitus in 3,123 participants. Completed in 30 November 2016.

Timeline
23 September 2014
Primary endpoint
30 November 2016
30 November 2016

Quick facts

Lead sponsorAstraZeneca
StatusCompleted
Study typeOBSERVATIONAL
Enrollment3,123
Start date23 September 2014
Primary completion30 November 2016
Estimated completion30 November 2016
Sites6 locations across South Korea

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Eligibility, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Characteristics of Dapagliflozin Responders: A Longitudinal, Prospective, Nationwide Dapagliflozin Surveillance Study in Korea.
    Han E, Kim A, Lee SJ, Kim JY, et al · · 2018 · cited 22× · PMID 29998370 · DOI 10.1007/s13300-018-0470-9

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Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02252224.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing