Clinical trial NCT02695082: Acute Kidney Injury in Patients on Dapagliflozin and Other Antidiabetic Medications
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-03-01
Enrollment: 539310
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be eligible for inclusion in this study if they are newly prescribed dapagliflozin and meet all inclusion criteria and no exclusion criteria.For each dapagliflozin user up to four controls will be matched. Patients with a history of diabetic nephropathy will be included, and this history will be accounted for in the analysis.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. do not have any diagnostic code indicating type1 diabetes;
3. 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
4. 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

Primary outcomes:
measure: Incidence of Acute Kidney injury (AKI)
timeFrame: Day after index date up to six years
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Research Site
state: Delaware
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Rti HealthSolutions
name: Catherine Johannes, Dr
role: PRINCIPAL_INVESTIGATOR
References: