Acute Kidney Injury in Patients on Dapagliflozin and Other Antidiabetic Medications

To compare, by insulin use at the index date, the incidence of hospitalization for acute kidney injury (AKI) 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

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, London, United Kingdom

About this study

The overall goal of this research study is to estimate the risk of hospitalization for acute kidney 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

receive newly prescribed dapagliflozin (with or without other ADs) or receive a newly prescribed AD (with or without other ADs) in a class other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy;
do not have any diagnostic code indicating type1 diabetes;
are aged 18 years or older at the index date for CPRD patients, 18-64 years for HIRDSM patients, or 65 years or older for Medicarepatients; and
have been enrolled in the data source for at least 180 days before the first prescription or dispensing dapagliflozin or eligible index comparator AD

Exclusion criteria

-previous diagnosis of chronic kidney failure

Treatment and study plan

Primary outcomes

Incidence of Acute Kidney injury (AKI)

Time frame: Day after index date up to six years

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 SGLT2 inhibitor, termination of health plan, transfer out of the GP practice, or end of the study period up to six years.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Mar 1, 2016
Registry last updated: Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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