Study identification

EU PAS number

EUPAS11845

Study ID

48256

Official title and acronym

An Observational Study of the Risk of Acute Pancreatitis in Subjects Exposed to Albiglutide, Other GLP-1 Agonists or DPP-4 Inhibitors Compared to Other Antidiabetic Agents (201804)

DARWIN EU® study

No

Study countries

United States

Study description

This study is a retrospective cohort study and will be conducted in the Truven Marketscan Commercial health insurance database. The study will: 1) evaluate the association between albiglutide and acute pancreatitis as compared to the association observed between this outcome and use of other antidiabetic agents (ADAs) (excluding GLP-1 agonists and DPP-4 inhibitors) and 2) evaluate the association between GLP-1 agonists (including and excluding albiglutide), DPP-4 inhibitors and acute pancreatitis as compared to the association observed between this outcome and use of other ADAs. The analysis will be conducted when 5000 and again when 31,000 subjects are exposed to albiglutide in this database. Unadjusted incidence rates of acute pancreatitis will be calculated for each exposure group. Time to acute pancreatitis will be assessed using Kaplan Meier survival curves with log rank test. Cox Proportional Hazards modeling will be used to compare the adjusted risk of acute pancreatitis among subjects treated with albiglutide, GLP-1 agonists excluding albiglutide, GLP-1 agonists including albiglutide, and DPP-4 inhibitors compared to other ADAs (reference group).

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)