Last updated: 11/07/2018 12:45:18

Assessment of Patients Treated with Albiglutide - Phase 1

GSK study ID
205787
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: Assessment of Patients Treated with Albiglutide - Phase 1
Trial description: Albiglutide, a Glucagon-like peptide-1 (GLP-1) receptor agonist, is a once-weekly injection of albiglutide approved as an adjunct to diet and exercise in adults with type 2 diabetes mellitus (T2DM) to improve glycemic control. This study will be completed in two phases: Phase 1 of this study was exploratory and Phase 1B will be conducted to examine the reproducibility of Phase 1 objectives over a 6-month period. This study is a retrospective database study with a goal to characterize early users of albiglutide and to assess the efficacy of albiglutide as measured by change in Glycated Hemoglobin (HbA1c) in both phases, and to examine medication persistence in subjects who initiate treatment with albiglutide in Phase 1B only. All subjects will be required to be continuously enrolled in the health plan for a minimum of 12 months. The date of the first filled prescription for albiglutide during the period will be identified as the index date. The six months prior to the index date ("baseline period") will be used to assess baseline characteristics. The six months following and inclusive of the index date ("follow up period") will be used to assess Proportion of Days Covered (PDC), number of albiglutide fills, and the albiglutide persistence/discontinuation; the 30 days prior to and following the six-month follow-up period (index date +151 through index date+211 days) will be used to assess HbA1c outcomes.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The first HbA1c result occurring in the follow-up period

Timeframe: Up to 7 months

Time to Follow-up HbA1c

Timeframe: Up to 7 months

Change in HbA1c from baseline to follow-up

Timeframe: Baseline and up to 7 months

The number of pharmacy fills for albiglutide

Timeframe: 6 months

The proportion of days (PDC) covered

Timeframe: 6 months

Baseline HbA1c result

Timeframe: 6 months

The time in days between the baseline HbA1c result and index date

Timeframe: 6 months

Baseline Quan-Charlson co-morbidity score

Timeframe: 6 months

Baseline comorbid conditions

Timeframe: 6 months

Baseline Diabetes Complications Severity Index (DCSI).

Timeframe: 6 months

Baseline use of oral anti-diabetic medications (OADs).

Timeframe: 6 months

Baseline use of insulin

Timeframe: 6 months

Baseline use of pramlintide

Timeframe: 6 months

Baseline use of GLP-1

Timeframe: 6 months

Baseline use of GLP-1 < 60 days before index date

Timeframe: 6 months

Baseline use of GLP-1 < 30 days before index date

Timeframe: 6 months

Baseline antidiabetic therapy regimen

Timeframe: 6 months

Baseline medications

Timeframe: 6 months

Baseline medication dispensings

Timeframe: 6 months

Baseline all-cause health care resource utilization

Timeframe: 6 months

Baseline diabetes-related health care resource utilization

Timeframe: 6 months

Baseline all-cause health care costs

Timeframe: 6 months

Baseline diabetes-related health care costs

Timeframe: 6 months

Patient's index date in baseline period

Timeframe: 6 months

Age of subjects

Timeframe: 6 months

Age groups for the enrolled subjects

Timeframe: 6 months

Number of subjects of each gender

Timeframe: 6 months

Number of subjects from each Geographic region

Timeframe: 6 months

Albiglutide dose on index date

Timeframe: 6 months

Last albiglutide dose

Timeframe: 6 months

Change in dose of albiglutide in the follow-up period

Timeframe: 6 months

Time to first dose change

Timeframe: 6 months

Discontinuation of index therapy

Timeframe: 6 months

Persistence with index therapy

Timeframe: 6 months

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Albiglutide
  • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Buysman EK, Sikirica MV, Thayer SW, Bogart M, DuCharme MC, Joshi AV. Real-World Comparison of Treatment Patterns and Effectiveness of Albiglutide and Liraglutide. J Compar Effect Res.2017;7(2):89-100.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    November 2015 to May 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Greater than or equal to 1 pharmacy claim for albiglutide between 29 July 2014 and 30 June 2015; the date of the earliest claim for albiglutide will be the index date
    • Age 18 or older as of the index year
    • Evidence of T1DM (ICD-9-CM diagnosis codes 250.x1, 250.x3 in any diagnosis position) AND >=1 claim for insulin during the base line period through the end of follow-up
    • Evidence of pregnancy or gestational diabetes in any diagnosis position during the baseline or follow-up periods

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

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

    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
    2016-27-05

    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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