Last updated: 11/03/2018 13:08:49

Prescription Patterns, Resource Utilization & Costs - Add-on Therapy with Anti Dipeptidyl Peptidase-IVs vs rosiglitazone

GSK study ID
112611
See study documents
Clinicaltrials.gov ID
NCT01332370
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: Prescription Patterns, Resource Utilization & Costs - Add-on Therapy with Anti Dipeptidyl Peptidase-IVs vs rosiglitazone
Trial description: This retrospective database study analyzed resource utilization and costs associated with sitagliptin (STG) in comparison with rosiglitazone (RSG) added to metformin (MET) monotherapy among adults with a diagnosis of diabetes who were continuously enrolled in a large US healthcare plan.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

medical resource utilization

Timeframe: at least 12 months following first prescription with RSG or STG as an add-on therapy to MET monotherapy.

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Rosiglitazone + Metformin
  • Drug: Sitagliptin + Metformin
    • Enrollment:
    5391
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    December 2009 to December 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 85 years
    Accepts healthy volunteers
    No
    • Continuously enrolled in the health insurance plan to ensure complete claims coverage
    • At least 1 claim with a diagnosis of diabetes (ICD-9 250.xx)
    • At least 1 claim for insulin or sulfonylurea in the baseline period
    • At least 1 claim with a diagnosis of congestive heart failure in the baseline period
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Continuously enrolled in the health insurance plan to ensure complete claims coverage
    • At least 1 claim with a diagnosis of diabetes (ICD-9 250.xx)
    • Aged 18 years or older at the index date
    • At least 6 months of baseline period prior to the index date
    • At least 1 claim for MET during the baseline period
    • At least 180 days of continuous therapy with RSG+MET or STG+MET after the index date
    Exclusion criteria:
    • At least 1 claim for insulin or sulfonylurea in the baseline period
    • At least 1 claim with a diagnosis of congestive heart failure in the baseline period

    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)

    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
    2010-23-12

    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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