Last updated: 11/03/2018 11:29:59

Resource utilization and costs associated with use of rosiglitazone versus insulin as add-on therapy to metformin users in the Veterans Administration

GSK study ID
111262
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Resource utilization and costs associated with use of rosiglitazone versus insulin as add-on therapy to metformin users in the Veterans Administration
Trial description: Diabetes is one of the most common chronic diseases and is also the leading cause of a variety of macro- and micro-vascular complications. The fundamental goal of managing type 2 diabetes mellitus (T2DM) is glycemic control. Besides, recommended diet and exercise, traditional agents such as metformin (MET), glyburide (sulfonylurea) or insulin (INS) are used towards achieving this objective. However, normoglycemia is frequently not obtained using traditional approaches and progressive loss of glycemic control has been shown to correlate with declining β-cell function.
National Patient Care Database (NPCD) was used in this study. The NPCD consists of medical and pharmaceutical claims and clinical information for all patients treated in the VHA hospitals and outpatient clinics nationwide. The VA is the largest health care provider in the world with the VHA branch of the VA providing health care services to approximately 6 million individuals a year. Data sources include all services provided at the system’s 155 medical centers, 882 ambulatory care and community-based outpatient clinics, 131 extended care facilities, and 73 comprehensive home care programs. In Fiscal Year (FY) 2007, the VA treated approximately 750,000 patients in hospitals, 106,000 in nursing homes, and 25,000 in domiciliaries. There are over 60 million encounters recorded in the outpatient datasets for each fiscal year from FY1997 to the present year.
This study is a retrospective observational cohort study.
The original objective of this study was to retrospectively evaluate the long-term compliance, resource utilization and costs associated with add-on therapy with RSG vs. INS in patients receiving MET monotherapy within the Veterans Health Administration (VHA) hospitals and outpatient clinics nationwide. The objective was revised to report only descriptive statistics because the study was terminated.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number and Percent of Subjects who Experienced Failure

Timeframe: up to 2 years

Secondary outcomes:

Treatment switch

Timeframe: up to 2 years

Interventions:
  • Drug: Rosiglitazone add-on thearpy
  • Drug: Insulin add-on therapy
    • Enrollment:
    3909
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    January 2010 to January 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40 - 64 Year
    Accepts healthy volunteers
    none
    • Subject received at least 1 prescription for any diabetes medication during the washout period or ≥2 ICD-9 codes for diabetes (250.xx) over a 24-month period prior to the index date
    • Subject received at least 1 prescription of MET with a minimum of 90 days supply as monotherapy during 6 months prior to the index date and no other glucose lowering drugs, including insulin, during the washout period.
    • Subjects with a diagnosis of heart failure during the washout period
    • Subjects on dialysis
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subject received at least 1 prescription for any diabetes medication during the washout period or ≥2 ICD-9 codes for diabetes (250.xx) over a 24-month period prior to the index date
    • Subject received at least 1 prescription of MET with a minimum of 90 days supply as monotherapy during 6 months prior to the index date and no other glucose lowering drugs, including insulin, during the washout period.
    • Subjects between the ages of 40-64 years at the end of follow-up (March 31, 2007). The lower age range has been selected to enhance the probability of limiting the sample to subjects with T2DM.
    • Subjects who continued combination therapy for at least 90 days from the index date
    Exclusion criteria:
    • Subjects with a diagnosis of heart failure during the washout period
    • Subjects on dialysis
    • Subjects who had serum creatinine levels (measured anytime during the washout period) > 1.5 mg per deciliter (133 µmol per liter) in the washout 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
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-06-01

    Plain language summaries

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

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website