Last updated: 02/03/2020 19:30:29

PRJ2379: A retrospective cohort study to assess the utilization of albiglutide among women of child bearing age in the U.S.

GSK study ID
201954
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: PRJ2379: A retrospective cohort study to assess the utilization of albiglutide among women of child bearing age in the U.S.
Trial description: There are no adequate and well-controlled studies of albiglutide in pregnant women. According to the United States Prescribing Information (USPI), albiglutide should not be used during pregnancy unless the expected benefit outweighs the potential risks. Due to the long washout period for albiglutide, consideration should be given to stopping albiglutide at least 1 month before a planned pregnancy, according to the USPI.
This is a retrospective observational analysis conducted in a U.S. medical and pharmacy claims database, Truven.
The objectives of the study are: To describe the utilization of albiglutide among women of child bearing age in general and pregnant woman in particular;
To assess the proportion and characteristics of type 2 diabetic women of child-bearing age who are prescribed albiglutide; and
To assess the proportion and characteristics of type 2 diabetic women who are prescribed albiglutide during pregnancy.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence rate and period prevalence for the various antidiabetic agents

Timeframe: Study period (2014-2019)

Proportion of pregnant women receiving various antidiabetic medications

Timeframe: Study period (2014-2019)

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Cohort
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 2021
Type
Observational
Phase
4

Participation criteria

Sex
Female
Age
11 - 49 Years
Accepts healthy volunteers
Not applicable
  • women aged between 11 to 49 years old
  • continuously enrolled in the health plan for >=3 months, had at least 1 claim of type 2 diabetes diagnosis and who had at least two prescription claims for a new antidiabetic agent (ADA) from 2014 (when albiglutide was launched in the U.S.) till the end of the study period
Inclusion and exclusion criteria
Inclusion criteria:
  • women aged between 11 to 49 years old
  • continuously enrolled in the health plan for >=3 months, had at least 1 claim of type 2 diabetes diagnosis and who had at least two prescription claims for a new antidiabetic agent (ADA) from 2014 (when albiglutide was launched in the U.S.) till the end of the study period

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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