Status: Ongoing First registered on: 29/06/2016
Last updated on: 19/05/2017
1. Study identification
EU PAS Register NumberEUPAS13904
Official titleIncidence of Thyroid Neoplasm and Pancreatic Cancer in Type 2 Diabetes Mellitus Patients who Initiate Once Weekly Exenatide Compared with Other Antihyperglycemic Drugs
Study title acronym
Study typeObservational study
Brief description of the studyThe study is intended to monitor the occurrence of thyroid neoplasm and pancreatic cancers with weekly exenatide. Anonymised electronic health care records will be used to monitor the weekly exenatide users and compare them to patients using other types of medication
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 applicableD5551N00007
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCPRD
Department/Research group
Organisation/affiliationClinical Practice Research Datalink
Website/Homepagewww.cprd.com
Details of (Primary) lead investigator
Title Ms
Last name Murray-Thomas
First name Tarita
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
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/10/201307/11/2013
Start date of data collection01/07/201101/07/2011
Start date of data analysis10/11/201310/11/2013
Date of interim report, if expected
Date of final study report31/12/2025
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 Ms
Last name Murray-Thomas
First name Tarita
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 AstraZeneca 
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 
Top