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Complications of UTI in Patients on Dapagliflozin

NCT ID: NCT02695173

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

683380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-11-30

Brief Summary

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The objective of this study is to compare, by insulin use at the index date, the sex-specific incidence of hospitalization or emergency department (ED) visit for severe complications of urinary tract infections (UTI), defined as pyelonephritis and urosepsis, among patients with type 2 diabetes mellitus (T2DM) 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 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

Conditions

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Severe Complications of Urinary Tract Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. 18 years and older (CPRD and HIRD), or 65 years or older (Medicare);
2. no diagnosisi of type 1 diabetes,
3. are new users of one of the study drugs and
4. have at least 180 days of electronic data before their first prescription of the study drug

Exclusion Criteria

1. The patient experienced chronic pyelonephritis at any time before the index date (i.e., during the available lookback time).
2. The patient was prescribed an SGLT2 inhibitor other than dapagliflozin on or before the index date.
3. The patient initiated metformin or sulfonylurea as AD monotherapy at the index date.
4. The patient initiated insulin therapy at the index date.
5. The patient had evidence of type 1 diabetes before cohort entry or first recorded AD is insulin monotherapy
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 Health Solutions

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

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1690R00008&attachmentIdentifier=df9e287e-3bd3-4bc0-bd8e-6342ad65d5fc&fileName=D1690R00008_CSR_Synopsis.pdf&versionIdentifier=

Related Info

Other Identifiers

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EUPAS12113

Identifier Type: REGISTRY

Identifier Source: secondary_id

D1690R00008

Identifier Type: -

Identifier Source: org_study_id