Last updated: 07/17/2024 17:18:29

Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects

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GSK study ID
204682
See study documents
Clinicaltrials.gov ID
NCT02750930
See results summary
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: An Open-label Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Subjects with Type 2 Diabetes Mellitus
Trial description: Albiglutide has been developed for the treatment of type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise, as monotherapy, or in combination with existing therapies and has been approved by the United States (US) Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory agencies. This is a 26 week, open-label, single group, multicenter, extension study to Study 200952. This extension study will provide extended safety, tolerability and immunogenicity data for the albiglutide liquid drug product. This extension study will comprise 2 study periods: treatment (26 weeks) and post-treatment follow-up (8 weeks). A maximum of 300 subjects will be eligible to take part in this extension study.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to Week 34

Number of participants with physical examination abnormalities

Timeframe: Up to Week 34

Number of participants with hematology values of potential clinical importance (PCI)

Timeframe: Up to Week 34

Number of participants with clinical chemistry parameters of PCI

Timeframe: Up to Week 34

Number of participants with clinically significant urinalysis abnormalities by dipstick method

Timeframe: Up to 26 weeks

Number of participants with pulse rate values of PCI

Timeframe: Up to Week 34

Number of participants with systolic and diastolic blood pressure of PCI

Timeframe: Up to Week 34

Number of participants with clinically significant findings for 12-lead ECG

Timeframe: Up to Week 34

Number of participant with positive results of anti-albiglutide antibody production over time

Timeframe: Up to Week 34

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Albiglutide
  • Device: Auto-injector
    • Enrollment:
    8
    Primary completion date:
    2017-21-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bonnie C. Shaddinger, Joseph Soffer, Georgios Vlasakakis, Mayadah Shabbout, Cynthia Weston, Antonio Nino. Efficacy and Safety of an Albiglutide Liquid Formulation Compared With the Lyophilized Formulation: A 26-Week Randomized, Double-Blind, Repeat-Dose Study in Patients With Type 2 Diabetes Mellitus. Diabetes Res Clin Pract. 2019;31627-9 DOI: 10.1016/j.diabres.2019.04.018 PMID: 31004676
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    October 2016 to March 2017
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Subjects who have completed the 26 week Treatment Phase of Study 200952
    • Male or female
    • Subject meets one or more of the withdrawal stopping criteria at Visit 1 (Week 26)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who have completed the 26 week Treatment Phase of Study 200952
    • Male or female
    • Able and willing to provide informed consent.
    Exclusion criteria:
    • Subject meets one or more of the withdrawal stopping criteria at Visit 1 (Week 26)

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Columbiana, North Carolina, United States, 28150
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Fresno, California, United States, 93720
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Schertz, Texas, United States, 782154
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

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

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    Actual primary completion date
    2017-21-03
    Actual study completion date
    2017-21-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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