Status: Finalised First registered on: 14/06/2016
Last updated on: 02/11/2020
1. Study identification
EU PAS Register NumberEUPAS13783
Official titleUtilisation of Dulaglutide in European Countries: A Cross-Sectional, Multi-Country and Multi-Source Drug Utilisation Study Using Electronic Health Record Databases
Study title acronymH9X-MC-B010
Study typeObservational study
Brief description of the studyThis study describes the frequency of dulaglutide use in different groups of patients in European countries, including the characterization of use by demographics, main comorbidities and comedications, overall and in subgroups of interest, including patients with specific diseases, children and adolescents, the elderly, and pregnant and breastfeeding women. Additionally, medication errors and off-label use will be described among patients using dulaglutide.
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 applicable
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 Dr
Last name Ali
First name Ayad
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

France
Germany
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/12/201415/12/2014
Start date of data collection13/06/201613/06/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report16/12/201914/11/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly and Company100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ali
First name Ayad
Address line 1Lilly Corporate Center
Address line 2 
Address line 3 
CityIndianapolis 
Postcode46254 
CountryUnited States
Phone number (incl. country code)1-3174338868 
Alternative phone number 
Fax number (incl. country code) 
Email address ali_ayad@lilly.com
Public Enquiries
Title Dr 
Last name Ali 
First name Ayad 
Address line 1Lilly Corporate Center 
Address line 2 
Address line 3 
CityIndianapolis 
Postcode46254 
CountryUnited States 
Phone number (incl. country code)1-3174338868 
Alternative phone number 
Fax number (incl. country code) 
Email address ali_ayad@lilly.com 
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