Last updated: 07/17/2024 16:45:29

Effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular events in subjects with Type 2 diabetes mellitus

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GSK study ID
116174
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Clinicaltrials.gov ID
NCT02465515
See results summary
EudraCT ID
2014-001824-32
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: A long term, randomised, double blind, placebo-controlled study to determine the effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular events in patients with Type 2 diabetes mellitus
Trial description: Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Time to first occurrence of major adverse cardiovascular events (MACE; cardiovascular death, myocardial infarction, or stroke) [Non-inferiority]

Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.

Secondary outcomes:

Time to first occurrence of MACE [Superiority]

Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.

Time to first occurrence of MACE or urgent revascularisation for unstable angina

Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.

Time to first occurrence of the individual components of the primary endpoint

Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.

Time to first occurrence of cardiovascular death or hospitalization due to heart failure

Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.

All cause mortality

Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.

Time to initiation of insulin of more than 3 months duration for those subjects not treated with insulin at study start

Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.

The proportion of subjects achieving glycemic control (HbA1c <=7.0% at final assessment) with no severe hypoglycemic incidents and weight gain <5% of body weight

Timeframe: Subjects will remain in the study until a specified number of MACE events have occurred. The maximum time subjects will be in the study is estimated to be between 3 and 5 years.

Interventions:
  • Biological/vaccine: Albiglutide 30 mg
  • Biological/vaccine: Albiglutide 50 mg
  • Biological/vaccine: Albiglutide matching placebo
    • Enrollment:
    9463
    Primary completion date:
    2018-20-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    John McMurray, Stefano Del Prato, Adrian Hernandez, Larry Leiter, Chris Granger, Ralph D’Agostino, Jennifer Green, Kristina Sigmon, Anne Rosenberg Nigel Jones, Karl Thorpe, Matt Somerville, Salim Janmohamed .Albiglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Cardiovascular Disease.Lancet.2018;392(10157):1519-1529 DOI: http://dx.doi.org/10.1016/S0140-6736(18)32261-X
    Medical condition
    Diabetes Mellitus
    Product
    albiglutide
    Collaborators
    Duke Clinical Research Institute
    Study date(s)
    July 2015 to March 2018
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
    • Diagnosis of type 2 diabetes.
    • Severely reduced kidney function: eGFR <30 ml/min/1.73 m^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
    • Use of a GLP-1 receptor agonist at Screening.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
    • Diagnosis of type 2 diabetes.
    • Established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
    • HbA1c >7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).
    • Able and willing to provide informed consent.
    Exclusion criteria:
    • Severely reduced kidney function: eGFR <30 ml/min/1.73 m^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
    • Use of a GLP-1 receptor agonist at Screening.
    • Severe gastroparesis
    • History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.
    • Personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic neuroendocrine tumours.
    • Medical history which might limit the subject’s ability to take trial treatments for the duration of the study or to otherwise complete the study.
    • Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.
    • Known allergy to any GLP-1 receptor agonist or excipients of albiglutide.
    • Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
    • Any other reason the investigator deems the subject to be unsuitable for the study.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    ALKMAAR, Netherlands, 1815 JD
    Status
    Study Complete
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    Location
    GSK Investigational Site
    AMSTERDAM, Netherlands, 1061 AE
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aberdeen, United Kingdom, AB25 2ZD
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Adrogue, Buenos Aires, Argentina, B1846DSK
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aguascalientes, Mexico, 20230
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aguascalientes, Ags, Aguascalientes, Mexico, 20127
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
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    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2018-20-02
    Actual study completion date
    2018-14-03

    Plain language summaries

    Summary of results in plain language
    Available language(s): English (UK), Greek, Spanish (Argentina), Spanish, Spanish (Mexico), Spanish (Peru), Filipino-Tagalog, French (Belgium), French (Canadian), Afrikaans, Bulgarian, Catalan, Czech, Danish, German, French, Galician, Hungarian, Italian, Korean, Norwegian, Dutch (Belgium), Dutch, Southern Sotho, Polish, Russian, Russian (Ukraine), Swedish, Thai, Ukrainian, Xhosa, Chinese (Hong Kong), Chinese (Taiwan), Zulu
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    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Additional information
    Not applicable
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