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Acute Kidney Injury in Patients on Dapagliflozin and Other Antidiabetic Medications

NCT ID: NCT02695082

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

539310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-11-30

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Johannes, Dr

Role: PRINCIPAL_INVESTIGATOR

Rti HealthSolutions

Locations

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Research Site

Wilmington, Delaware, United States

Site Status

Research Site

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

Site Status

Research Site

London, , United Kingdom

Site Status

Countries

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United States United Kingdom

References

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Johannes CB, Beachler DC, Layton JB, Danysh HE, Ziemiecki R, Arana A, Dinh J, Li L, Calingaert B, Pladevall-Vila M, Hunt PR, Chen H, Karlsson C, Johnsson K, Gilsenan A. Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting. Drug Saf. 2023 Feb;46(2):157-174. doi: 10.1007/s40264-022-01263-3. Epub 2022 Dec 17.

Reference Type DERIVED
PMID: 36528670 (View on PubMed)

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1690R00004&attachmentIdentifier=02ceaf43-ac7a-46b9-b044-6321cee7664c&fileName=D1690R00004_CSR_Synopsis.pdf&versionIdentifier=

Related Info

Other Identifiers

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EUPAS11684

Identifier Type: REGISTRY

Identifier Source: secondary_id

D1690R00004

Identifier Type: -

Identifier Source: org_study_id