Status: Ongoing First registered on: 15/01/2016
Last updated on: 18/03/2020
1. Study identification
EU PAS Register NumberEUPAS12113
Official titleComparison of the Risk of Severe Complications of Urinary Tract Infections (UTI) Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments
Study title acronym
Study typeObservational study
Brief description of the studyThe 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 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableD1690R00008
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Johannes
First name Catherine
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

RTI-HS
Healthcore, United States
Countries in which this study is being conducted
International study

United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed12/02/201512/02/2015
Start date of data collection29/01/201602/02/2016
Start date of data analysis
Date of interim report, if expected30/12/201622/11/2016
Date of final study report30/11/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstra Zeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Johannes
First name Catherine
Address line 1307 Waverley Oaks Road
Address line 2Suite 101 
Address line 3 
CityWaltham 
Postcode02452 
CountryUnited States
Phone number (incl. country code)17814341784 
Alternative phone number 
Fax number (incl. country code) 
Email address cjohannes@rti.org
Public Enquiries
Title Dr 
Last name AstraZeneca 
First name Clinical Study Information Center 
Address line 11800 Concord Pike 
Address line 2PO Box 15437 
Address line 3 
CityWilmington 
Postcode19850 
CountryUnited States 
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Email address information.center@astrazeneca.com 
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