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NCT02695095

Acute Liver Injury in Patients on Dapagliflozin

Completed Last updated 13 December 2021
What this trial tests

trial in Acute Liver Injury in 424,091 participants. Completed in 30 November 2020.

Timeline
1 January 2017
Primary endpoint
1 September 2020
30 November 2020

Quick facts

Lead sponsorAstraZeneca
StatusCompleted
Study typeOBSERVATIONAL
Enrollment424,091
Start date1 January 2017
Primary completion1 September 2020
Estimated completion30 November 2020
Sites3 locations across United Kingdom, United States

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Eligibility, any sex, with Acute Liver Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To compare, by insulin use at the index date, the incidence of hospitalization for acute liver injury (ALI) among patients with type 2 diabetes mellitus who are new users of dapagliflozin with those who are new users of antidiabetic drugs (ADs) in classes other than sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy.

Publications & conference data

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

  1. Post-Authorization Safety Studies of Acute Liver Injury and Severe Complications of Urinary Tract Infection in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting.
    Danysh HE, Johannes CB, Beachler DC, Layton JB, et al · · 2023 · cited 2× · PMID 36583828 · DOI 10.1007/s40264-022-01262-4

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Other recruiting trials for Acute Liver Injury

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/NCT02695095.

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