- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02695173
Complications of UTI in Patients on Dapagliflozin
Comparison of the Risk of Severe Complications of Urinary Tract Infections Between Patients With Type 2 Diabetes Exposed to Dapafliglozin and Those Exposed to Other Antidiabetic Treatments
Study Overview
Status
Detailed Description
The overall goal of this research study is to estimate the sex-specific incidence of hospitalization or emergency department visit for severe complications of urinary tract infections, defined as pyelonephritis and urosepsis, 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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom
- Research Site
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Delaware
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Wilmington, Delaware, United States
- Research Site
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District of Columbia
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Washington, District of Columbia, United States
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years and older (CPRD and HIRD), or 65 years or older (Medicare);
- no diagnosisi of type 1 diabetes,
- are new users of one of the study drugs and
- have at least 180 days of electronic data before their first prescription of the study drug
Exclusion Criteria:
- The patient experienced chronic pyelonephritis at any time before the index date (i.e., during the available lookback time).
- The patient was prescribed an SGLT2 inhibitor other than dapagliflozin on or before the index date.
- The patient initiated metformin or sulfonylurea as AD monotherapy at the index date.
- The patient initiated insulin therapy at the index date.
- The patient had evidence of type 1 diabetes before cohort entry or first recorded AD is insulin monotherapy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of urinary tract infections (UTI) complications
Time Frame: Day after index date up to six years
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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 or transfer out of the GP practice, or end of the study period (up to six years)
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Day after index date up to six years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of pyelonephritis
Time Frame: Day after index date up to six years
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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 or transfer out of the GP practice, or end of the study period (up to six years)
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Day after index date up to six years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Catherine Johannes, Dr, RTI Health Solutions
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1690R00008
- EUPAS12113 (Registry Identifier: ENCePP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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