Status: Finalised First registered on: 15/12/2015
Last updated on: 26/02/2019
1. Study identification
EU PAS Register NumberEUPAS11841
Official titleA cohort study to investigate the prescribing of albiglutide among women of child-bearing age who have type 2 diabetes
Study title acronym201795
Study typeObservational study
Brief description of the studyWith the cancellation of the Eperzan EU MA in January 2019, this post marketing study is no longer required or feasible to conduct. This is a cohort study using the UK Clinical Practice Research Datalink, CPRD, a national primary care database. A cohort of women aged 11 to 49 years with type 2 diabetes will be followed; a sub-group of women who have a pregnancy during the study period will also be identified. The objectives of this study are to: 1) assess the proportion and characteristics of women with type 2 diabetes of child-bearing age who are prescribed albiglutide, 2) assess the proportion and characteristics of women with type 2 diabetes who are prescribed albiglutide during pregnancy, 3) summarise outcomes of women prescribed albiglutide during pregnancy including reported major congenital malformations, pregnancy losses, stillbirths and neonatal deaths.
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 belongsUniversity of Bath
Department/Research groupPharmacy & Pharmacology
Organisation/affiliationUniversity of Bath
Website/Homepagewww.bath.ac.uk
Details of (Primary) lead investigator
Title Professor
Last name GSK Clinical Disclosure Advisor
First name GSK Clinical Disclosure Advisor
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 signed18/04/201517/11/2015
Start date of data collection01/01/201517/11/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report21/09/202010/01/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGlaxoSmithKline100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name GSK Clinical Disclosure Advisor
First name GSK Clinical Disclosure Advisor
Address line 1980 Great West Road
Address line 2 
Address line 3 
CityBrentford 
PostcodeTW8 9GS 
CountryUnited Kingdom
Phone number (incl. country code)44-2080-475000 
Alternative phone number 
Fax number (incl. country code) 
Email address Pharma.CDR@gsk.com
Public Enquiries
Title Professor 
Last name GSK Clinical Disclosure Advisor 
First name GSK Clinical Disclosure Advisor 
Address line 1980 Great West Road 
Address line 2 
Address line 3 
CityBrentford 
PostcodeTW8 9GS 
CountryUnited Kingdom 
Phone number (incl. country code)44-2080-475000 
Alternative phone number 
Fax number (incl. country code) 
Email address Pharma.CDR@gsk.com 
Top