Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial Public Deposited

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  • Holman, R.R.
    • Other Affiliation: University of Oxford, Oxford
  • Bethel, M.A.
    • Other Affiliation: University of Oxford, Oxford
  • George, J.
    • Other Affiliation: University of Oxford, Oxford
  • Sourij, H.
    • Other Affiliation: University of Oxford, Oxford
  • Doran, Z.
    • Other Affiliation: University of Oxford, Oxford
  • Keenan, J.
    • Other Affiliation: University of Oxford, Oxford
  • Khurmi, N.S.
    • Other Affiliation: AstraZeneca Research and Development
  • Mentz, R.J.
    • Other Affiliation: Duke University School of Medicine
  • Oulhaj, A.
    • Other Affiliation: University of Oxford, Oxford
  • Buse, J.B.
    • Affiliation: School of Medicine
  • Chan, J.C.
    • Other Affiliation: The Chinese University of Hong Kong
  • Iqbal, N.
    • Other Affiliation: Bristol-Myers Squibb
  • Kundu, S.
    • Other Affiliation: Bristol-Myers Squibb
  • Maggioni, A.P.
    • Other Affiliation: ANMCO Research Centre
  • Marso, S.P.
    • Other Affiliation: University of Texas Southwestern Medical Center
  • Öhman, P.
    • Other Affiliation: AstraZeneca Research and Development
  • Pencina, M.J.
    • Other Affiliation: Duke University School of Medicine
  • Poulter, N.
    • Other Affiliation: Imperial College London
  • Porter, L.E.
    • Other Affiliation: Dance Biopharm, Inc
  • Ramachandran, A.
    • Other Affiliation: India Diabetes Research Foundation
  • Zinman, B.
    • Other Affiliation: University of Toronto
  • Hernandez, A.F.
    • Other Affiliation: Duke University School of Medicine
Abstract
  • Exenatide once-weekly is an extended release formulation of exenatide, a glucagon-like peptide–1 receptor agonist, which can improve glycemic control, body weight, blood pressure, and lipid levels in patients with type 2 diabetes mellitus (T2DM). The EXenatide Study of Cardiovascular Event Lowering (EXSCEL) will compare the impact of adding exenatide once-weekly to usual care with usual care alone on major cardiovascular outcomes. EXSCEL is an academically led, phase III/IV, double-blind, pragmatic placebo-controlled, global trial conducted in 35 countries aiming to enrol 14,000 patients with T2DM and a broad range of cardiovascular risk over approximately 5 years. Participants will be randomized (1:1) to receive exenatide once-weekly 2 mg or matching placebo by subcutaneous injections. The trial will continue until 1,360 confirmed primary composite cardiovascular end points, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, have occurred. The primary efficacy hypothesis is that exenatide once-weekly is superior to usual care with respect to the primary composite cardiovascular end point. EXSCEL is powered to detect a 15% relative risk reduction in the exenatide once-weekly group, with 85% power and a 2-sided 5% alpha. The primary safety hypothesis is that exenatide once-weekly is noninferior to usual care with respect to the primary cardiovascular composite end point. Noninferiority will be concluded if the upper limit of the CI is <1.30. EXSCEL will assess whether exenatide once-weekly can reduce cardiovascular events in patients with T2DM with a broad range of cardiovascular risk. It will also provide long-term safety information on exenatide once-weekly in people with T2DM. ClinicalTrials.gov Identifier: NCT01144338
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Resource type
  • Article
Rights statement
  • In Copyright
Journal title
  • American Heart Journal
Journal volume
  • 174
Page start
  • 103
Page end
  • 110
Language
  • English
ISSN
  • 0002-8703
Publisher
  • Mosby Inc.
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