Last updated: 02/03/2020 19:30:21

PRJ2331: An Observational Study of the Risk of Malignant Neoplasms and Malignant Neoplasms of Special Interest (Thyroid and Pancreatic Cancer) in Subjects Treated with Albiglutide Compared to Those Treated with Other Antidiabetic Agents

GSK study ID
201805
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: PRJ2331: An Observational Study of the Risk of Malignant Neoplasms and Malignant Neoplasms of Special Interest (Thyroid and Pancreatic Cancer) in Subjects Treated with Albiglutide Compared to Those Treated with Other Antidiabetic Agents
Trial description: This study is a case-control study nested within a diabetes cohort, to be conducted using the Clinical Practice Research Datalink (CPRD) of the U.K. The objectives of this study are:
To compare the risk of malignant neoplasms of special interest (thyroid and pancreatic cancer) in subjects prescribed albiglutide, compared to other antidiabetic agents;
To compare the risk of malignant neoplasms of special interest (thyroid and pancreatic cancer) in subjects prescribed albiglutide in combination with insulin, compared to insulin;
To compare the risk of the most common malignant neoplasms (breast, prostate, colorectal and lung) in subjects prescribed albiglutide in combination with insulin, compared to insulin.
The secondary objective of the study is to assess the relationship between the dose and duration of exposure to albiglutide and malignant neoplasms of special interest.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Malignant neoplasms

Timeframe: study duration

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
10000
Primary completion date:
Not applicable
Observational study model:
Case-Control
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
November 2015 to November 2024
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
  • male and female
  • ≥ 18 years old
  • a history of the malignant neoplasms of special interest or a history of the common malignant neoplasms prior to cohort entry will be excluded
Inclusion and exclusion criteria
Inclusion criteria:
  • male and female
  • ≥ 18 years old
  • at least three consecutive new prescriptions (“new users”) for the same antidiabetic agent (ADA) in the Clinical Practice Research Datalink (CPRD) as of when albiglutide will be fully launched in the U.K
Exclusion criteria:
  • a history of the malignant neoplasms of special interest or a history of the common malignant neoplasms prior to cohort entry will be excluded

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Additional information
Not applicable
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