Status: Finalised First registered on: 18/04/2016
Last updated on: 10/04/2017
1. Study identification
EU PAS Register NumberEUPAS13199
Official titleObservational single-cohort data base study of dapagliflozin utilisation in Europe
Study title acronymNA
Study typeObservational study
Brief description of the studyThis drug utilization study is set up to describe the characteristics of European patients newly prescribed dapagliflozin by age, sex, dapagliflozin dose, country, selected co-morbidities, and selected concomitant medications. It will specifically describe dapagliflozin use in: • patients > 75 years-old, • combination use with loop diuretics or pioglitazone, • patients with a known history of moderate or severe renal impairment and in kidney failure, • patients lacking a diagnostic code indicating type 2 diabetes. This is an observational single-cohort data base study with descriptive data analyses among patients receiving dapagliflozin within electronic medical records in Europe. The study will describe the utilization pattern of dapagliflozin during the first 3.5 years after marketing authorization and launch in Europe, specifically in Belgium, France, Germany, Italy, Spain and United Kingdom. Will be included in the study all patients identified in the database(s) who newly received at least one dapagliflozin prescription during the study period. Data will be collected from IMS Health Longitudinal Patient Databases (LPDs) which come directly from physicians’ EMR. A patient will be identified as newly exposed when he/she has at least one dapagliflozin prescription recorded in the study database(s). Outcomes include: Patient demographics: age, sex, country, Baseline history of type 2 diabetes, Baseline history of moderate or severe renal impairment, Concomitant medications at baseline and during dapagliflozin use. Follow-up will begin on the date a patient is first prescribed dapagliflozin, and it will continue until the end of study or discontinuation of dapagliflozin. In this study descriptive analyses of the data will be conducted.
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 applicableD1690R00006
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Mrs
Last name Asmar
First name Joelle
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Belgium
France
Germany
Italy
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/03/2013
Start date of data collection01/01/2013
Start date of data analysis
Date of interim report, if expected
Date of final study report12/10/201615/12/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mrs
Last name Asmar
First name Joelle
Address line 11800 Concord Pike
Address line 2PO BOX 15437 
Address line 3 
CityWilmington, De 
Postcode19850 
CountryUnited States
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Email address information.center@astrazeneca.com
Public Enquiries
Title Dr 
Last name Astra Zeneca 
First name Clinical Study Information Center 
Address line 11800 Concord Pike 
Address line 2PO BOX 15437 
Address line 3 
CityWilmington, De 
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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