Acute Liver Injury in Patients on Dapagliflozin

Acute Liver Injury Clinical Trial

Official title:

Comparison of the Risk of Acute Liver Injury Between Patients With Type 2 Diabetes Exposed to Dapafliglozin and Those Exposed to Other Antidiabetic Treatments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695095
• Other study ID #: D1690R00005
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The overall goal of this research study is to estimate the risk of hospitalization for acute liver injury in patients who are prescribed dapagliflozin compared to patients prescribed other specific oral antidiabetic drugs. Dapagliflozin and other antidiabetic drugs are used to treat type 2 diabetes mellitus. Because of the mechanism of action for dapagliflozin and results from small safety monitoring studies, there is interest in further evaluating the safety of dapagliflozin in large populations.

The study will be implemented in three administrative health care data sources in two countries: in the United Kingdom, the Clinical Practice Research Datalink (CPRD); and in the United States, the Centers for Medicare and Medicaid Services (CMS) Medicare databases and the HealthCore Integrated Research Database (HIRDSM). Individuals in the databases will be included in the study if they meet the following age criteria; 18 years and older (CPRD and HIRD), or 65 years or older (Medicare); and if they did not have type 1 diabetes, are new users of one of the study drugs and meet the criteria of at least 180 days of electronic data before their first prescription of the study drug. The study period starts July 1, 2013 in CPRD, January 1, 2014 in PHARMO and January 9, 2014 in the United States data sources, and will end at the latest available data at each database at the time of analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424091
• Est. completion date: November 30, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 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;

2. do not have evidence of type 1 diabetes;

3. 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

4. have been enrolled in the data source for at least 180 days before the first prescription or dispensing for dapagliflozin or comparator AD.

Exclusion Criteria:

• previous diagnosis of ALI; liver, biliary, or pancreatic disease; hepatobiliary or pancreatic neoplasm; or congestive heart failure

Related Conditions & MeSH terms

• Acute Liver Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United Kingdom	Research Site	London
United States	Research Site	Washington	District of Columbia
United States	Research Site	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   CSR Synopsis