Acute Kidney Injury in Patients on Dapagliflozin and Other Antidiabetic Medications
Comparison of the Risk of Acute Kidney Inury Between Patients With Type 2 Diabetes Exposed to Dapafliglozin and Those Exposed to Other Antidiabetic Treatments
2 other identifiers
observational
539,310
2 countries
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2016
CompletedFirst Posted
Study publicly available on registry
March 1, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedDecember 7, 2021
November 1, 2021
3.7 years
February 18, 2016
November 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Acute Kidney injury (AKI)
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.
Day after index date up to six years
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- previous diagnosis of chronic kidney failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Wilmington, Delaware, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
London, United Kingdom
Related Publications (1)
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.
PMID: 36528670DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Johannes, Dr
Rti HealthSolutions
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 7, 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.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.