Last updated: 11/07/2018 11:35:46

Glucagon-like peptide (GLP) Utilization and safety

GSK study ID
200065
See study documents
Clinicaltrials.gov ID
NCT01767389
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Glucagon-like peptide-1 (GLP-1) agonists: Treatment utilization patterns and risk of acute pancreatitis
Trial description: This study will assess the utilization patterns (adherence, source of the index antidiabetic agent (ADA) and treatment modification) of the marketed glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide and liraglutide), dipeptidyl-peptidase-4 (DPP-4) inhibitors (sitagliptin, saxagliptin, and linagliptin) and other ADAs and the incidence rate of acute pancreatitis among the users of these GLP-1 receptor agonists and users of DPP-4 inhibitors, separately, in comparison to other ADAs.
The proposed study will help in understanding the treatment utilization patterns and the incidence rate of acute pancreatitis among users of the marketed GLP-1 receptor agonists. This study differs from previous observational studies by including both exenatide and liraglutide and follow-up time is expected to be longer in the current study (2005 – 2011).
This study will be a retrospective cohort study conducted in the Truven (Thomson Reuters) commercial health insurance database from 2005-2011.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

For treatment utilization patterns: adherence will be assessed.

Timeframe: 6 years

For treatment utilization patterns: source of the index ADA (add-on, switch or new therapy) will be assessed.

Timeframe: 6 years

For treatment utilization patterns: treatment modification (discontinuation of the index ADA, switching of the index and concomitant ADA, and add-on therapy) will be assessed.

Timeframe: 6 years

Secondary outcomes:
Not applicable
Interventions:
  • Other: The GLP-1 receptor agonist users
  • Other: DPP-4 inhibitor users
  • Other: Other ADA users
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Elizabeth Suarez,Carol Koro,Jennifer Christian, Alicia Spector,Andre Araujo,Sybil Abraham.Incretin-mimetic therapies and pancreatic disease: a review of observational data.Curr Med Res Opin.2014;30(12):2471-2481
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    September 2012 to December 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 years
    Accepts healthy volunteers
    No
    • Subjects aged ≥ 18 and ≤ 64 years as of index date and those who have continuous enrolment for at least 12 months in Truven
    • Subjects should have complete medical and pharmacy benefits and continuous enrolment in the health plan for at least 12 months before the index date (pre-index period).
    • For the objective of evaluating the association between GLP-1 receptor agonists, DPP-4 inhibitors and acute pancreatitis as compared to the association observed between this outcome and the use of other ADAs, subjects having evidence of pancreatic disease (ICD 9 code of 577.xx) in the pre-index period (12 months before the index date) will be excluded.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects aged ≥ 18 and ≤ 64 years as of index date and those who have continuous enrolment for at least 12 months in Truven
    • Subjects should have complete medical and pharmacy benefits and continuous enrolment in the health plan for at least 12 months before the index date (pre-index period).
    • Subjects should also have at least 1 claim of T2D diagnosis identified using ICD-9 codes 250.x0 or 250.x2 (excluding 250.x1 and/or 250.x3 – Type 1 diabetes and 648.0x – gestational diabetes)
    Exclusion criteria:
    • For the objective of evaluating the association between GLP-1 receptor agonists, DPP-4 inhibitors and acute pancreatitis as compared to the association observed between this outcome and the use of other ADAs, subjects having evidence of pancreatic disease (ICD 9 code of 577.xx) in the pre-index period (12 months before the index date) will be excluded.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2013-13-12

    Plain language summaries

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

    Additional information about the trial

    Not applicable
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