Acute Liver Injury in Patients on Dapagliflozin
Completed
Conditions studied: Acute Liver Injury
In brief
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.
Key facts
- Study ID
- NCT02695095
- Run by
- AstraZeneca
- People needed
- 424091
- Starts
- 2017-01-01
- Expected to finish
- 2020-11-30
- Last updated by the study team
- 2021-12-13
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- receive newly prescribed dapagliflozin (with or without other ADs) or a newly prescribed AD (with or withoutother ADs) in a class other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylureamonotherapy;
- do not have evidence of type 1 diabetes;
- are aged 18 years or older at the index date for CPRDpatients, 18-64 years for HIRDSM patients, or 65 years or older for Medicare patients; and
- have been enrolled in the data source for at least 180 days before the first prescription or dispensing for dapagliflozin or comparator AD.
You may not qualify if…
- previous diagnosis of ALI; liver, biliary, or pancreatic disease; hepatobiliary or pancreatic neoplasm; or congestive heart failure
Where it is running
- Research Site — Wilmington, Delaware, United States
- Research Site — Washington D.C., District of Columbia, United States
- Research Site — London, United Kingdom
Full record on ClinicalTrials.gov
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