Acute Liver Injury in Patients on Dapagliflozin

NCT02695095 | Completed

• 1 other identifier: D1690R00005
• Study Type: observational
• Target: 424,091
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Acute Liver Injury

Outcome Measures

Primary Outcomes (1)

• incidence of acute liver injury

  Patients will be followed from their index date (date of first study drug prescription or dispensing) until they experience one of the following: an event under study, end of time at risk for index medication, death, addition of a non-dapagliflozin (up to six years)

  Day after index day up to six years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are new users of dapagliflozin or the eligible comaprator drugs that meet the inclusion criteria and none of teh exclusion criteria. Comparator patients will be matched to the dapagliflozin patients by propensity score if access to all eligible comparator subjects is feasible.

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Wilmington, Delaware, United States

Location

Research Site

Washington D.C., District of Columbia, United States

Location

Research Site

London, United Kingdom

Location

Related Links

• CSR Synopsis

Study Officials

• Catherine Johannes, Dr

  RTI Health Solutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 1, 2016
• Study Start: January 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: November 30, 2020
• Last Updated: December 13, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

GB (1); US (2)