Last updated: 02/04/2020 17:00:06

Reasons and Consequences for Discontinuation and Adherence with Daily Glucagon-like Peptide-1 Therapies in Type 2 Diabetes Mellitus Patients in the United States

GSK study ID
200896
See study documents
Clinicaltrials.gov ID
Not applicable
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: Reasons and Consequences for Discontinuation and Adherence with Daily Glucagon-like Peptide-1 Therapies in Type 2 Diabetes Mellitus Patients in the United States
Trial description: Most patients with Type 2 diabetes mellitus (T2DM) will experience progressive beta-cell dysfunction and require insulin monotherapy or in combination with oral agents. However, some insulin regimens are associated with hypoglycemia and/or weight gain. Hypoglycemia can affect overall glucose control, and fear of hypoglycemia can impact treatment adherence. The majority of patients with T2DM are overweight or obese and increasing weight gain may worsen insulin resistance and increase cardiovascular disease risk and overall disease burden. Given these factors, there is an interest in therapies that minimize the risk of hypoglycemia, are either weight neutral or promote weight loss in overweight patients, and engage physiologic mechanisms to modify T2DM. Incretin-based therapies, including Glucagon-like Peptide-1(GLP-1) receptor agonists, do not induce weight gain and may lead to progressive, sustained weight loss for patients.
The primary objective of this study is to examine treatment patterns associated with the initiation of GLP-1 therapy for the treatment of T2DM. This exploratory analysis will evaluate persistence and adherence with GLP-1 therapy, as well as describe patient-reported reasons for discontinuing GLP-1 therapy in a subset of subjects.
This study will be conducted in two parts. Part 1 of the study will be a retrospective claims-based analysis to assess persistence and adherence with GLP-1 therapies and associated clinical and economic outcomes. Part 2 of the study will be a prospective claims-linked, direct-to-patient survey of recent discontinuers of GLP-1 therapy to assess patient-reported reasons for discontinuation and/or non-adherence with GLP-1 and to investigate the relationship between reasons for discontinuation, treatment patterns, and outcomes.
The data source for this study will be a proprietary research database containing claims and enrollment data dating back to 1993 with the opportunity to link patient and physician survey data to pharmacy and medical claims, medical record data, socioeconomic measures, and clinical laboratory results.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Discontinuation of GLP-1 therapy

Timeframe: up to 3 years

Secondary outcomes:

Reason for discontinuation

Timeframe: up to 3 years

Medication adherence

Timeframe: up to 3 years

All cause resource use

Timeframe: up to 3 years

Interventions:
  • Drug: GLP-1
    • Enrollment:
    0
    Primary completion date:
    2014-14-03
    Observational study model:
    Cohort
    Time perspective:
    Other
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    June 2012 to March 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • age =>18 years as of the index year
    • continuous enrollment in the 6 months prior to the index date (baseline period) and for a minimum of 90 days following the index date
    • pharmacy claims for GLP-1 in the baseline period
    • medical claims indicating gestational diabetes (ICD-9-CM diagnosis codes 648.8x in the primary or secondary position or HCPCS S9214) during the baseline or follow-up periods
    Inclusion and exclusion criteria
    Inclusion criteria:
    • age =>18 years as of the index year
    • continuous enrollment in the 6 months prior to the index date (baseline period) and for a minimum of 90 days following the index date
    • evidence of T2DM. T2DM will be identified via medical claims with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code of 250.x0 or 250.x2 and/or pharmacy claims for oral antidiabetic agents
    • =>1 pharmacy claim for a GLP-1 (exenatide or liraglutide)
    • For Part 2, evidence of discontinuation of GLP-1 therapy during the follow-up period (see Section 4.1.1 for a definition of GLP-1 discontinuation). Patients who discontinue in the time period closest to the survey date will be targeted for survey participation
    • For Part 2, willingness to sign and return the informed consent and health information release forms
    Exclusion criteria:
    • pharmacy claims for GLP-1 in the baseline period
    • medical claims indicating gestational diabetes (ICD-9-CM diagnosis codes 648.8x in the primary or secondary position or HCPCS S9214) during the baseline or follow-up periods
    • females with medical claims indicating pregnancy, labor, or delivery during the baseline or follow-up periods

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    2014-14-03
    Actual study completion date
    2014-14-03

    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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