Study identification

EU PAS number

EUPAS11841

Study ID

42105

Official title and acronym

A cohort study to investigate the prescribing of albiglutide among women of child-bearing age who have type 2 diabetes (201795)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

With 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.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

GSK Clinical Disclosure Advisor GSK Clinical Disclosure Advisor Pharma.CDR@gsk.com

Study contact
Pharma.CDR@gsk.com

GSK Clinical Disclosure Advisor GSK Clinical Disclosure Advisor

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)