Jennifer B Green1, Adrian F Hernandez1, Ralph B D'Agostino2, Chris B Granger1, Salim Janmohamed3, Nigel P Jones3, Lawrence A Leiter4, Drusilla Noronha3, Rachael Russell5, Kristina Sigmon1, Stefano Del Prato6, John J V McMurray7. 1. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. 2. Department of Mathematics and Statistics, Boston University, Boston, MA. 3. GlaxoSmithKline Pharmaceuticals, Middlesex, United Kingdom. 4. Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, Ontario, Canada. 5. GlaxoSmithKline Pharmaceuticals, Collegeville, PA. 6. Section of Diabetes, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. 7. British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, United Kingdom. Electronic address: john.mcmurray@glasgow.ac.uk.
Abstract
BACKGROUND:Albiglutide is a long-acting glucagon-like peptide-1 receptor agonist that improves glycemic control in patients with type 2 diabetes mellitus (T2DM). Harmony Outcomes is a randomized, double-blind, placebo-controlled trial of the effect of albiglutide on major adverse cardiovascular (CV) events in patients with T2DM and established CV disease. METHODS: The trial was designed to recruit 9,400 patients aged ≥40 years with T2DM, prior atherosclerotic CV disease, and suboptimal glycemic control. Participants were assigned in a 1:1 ratio to albiglutide 30 mg (potentially increasing to 50 mg) or matching placebo administered once weekly by subcutaneous injection. The trial will continue until ≥611 confirmed primary outcome events (CV death, myocardial infarction, or stroke) occur over a median follow-up of at least 1.5 years. RESULTS: A total of 9,463 patients were enrolled at 611 sites in 28 countries between July 2015 and December 2016. The mean age was 64.1 years; duration of T2DM, 13.8 years; and glycated hemoglobin, 8.7%. The percentage of patients with prior coronary artery disease was 70.5%; peripheral arterial disease, 25.0%; stroke, 17.7%; heart failure, 20.2%; and chronic kidney disease, 22.6%. CONCLUSIONS: Harmony Outcomes will assess the CV safety of albiglutide in patients with T2DM and CV disease. Trials of other agents in the glucagon-like peptide-1 receptor agonist class have shown CV benefit for only some of these medications, possibly due to differences in trial design or instead due to differences in drug structure or metabolism. Harmony Outcomes will provide information critical to our understanding of this heterogenous class of glucose-lowering agents.
RCT Entities:
BACKGROUND: Albiglutide is a long-acting glucagon-like peptide-1 receptor agonist that improves glycemic control in patients with type 2 diabetes mellitus (T2DM). Harmony Outcomes is a randomized, double-blind, placebo-controlled trial of the effect of albiglutide on major adverse cardiovascular (CV) events in patients with T2DM and established CV disease. METHODS: The trial was designed to recruit 9,400 patients aged ≥40 years with T2DM, prior atherosclerotic CV disease, and suboptimal glycemic control. Participants were assigned in a 1:1 ratio to albiglutide 30 mg (potentially increasing to 50 mg) or matching placebo administered once weekly by subcutaneous injection. The trial will continue until ≥611 confirmed primary outcome events (CV death, myocardial infarction, or stroke) occur over a median follow-up of at least 1.5 years. RESULTS: A total of 9,463 patients were enrolled at 611 sites in 28 countries between July 2015 and December 2016. The mean age was 64.1 years; duration of T2DM, 13.8 years; and glycated hemoglobin, 8.7%. The percentage of patients with prior coronary artery disease was 70.5%; peripheral arterial disease, 25.0%; stroke, 17.7%; heart failure, 20.2%; and chronic kidney disease, 22.6%. CONCLUSIONS: Harmony Outcomes will assess the CV safety of albiglutide in patients with T2DM and CV disease. Trials of other agents in the glucagon-like peptide-1 receptor agonist class have shown CV benefit for only some of these medications, possibly due to differences in trial design or instead due to differences in drug structure or metabolism. Harmony Outcomes will provide information critical to our understanding of this heterogenous class of glucose-lowering agents.
Authors: S Kalra; S Ghosh; A K Das; T Nair; S Bajaj; G Priya; R N Mehrotra; S Das; P Shah; V Deshmukh; M Chawla; D Sanyal; S Chandrasekaran; D Khandelwal; A Joshi; F Eliana; H Permana; M D Fariduddin; P K Shrestha; D Shrestha; S Kahandawa; M Sumanathilaka; A Shaheed; A A Rahim; A Orabi; A Al-Ani; W Hussein; D Kumar; K Shaikh Journal: Indian Heart J Date: 2020-01-13
Authors: Emily C O'Brien; Sudha R Raman; Alicia Ellis; Bradley G Hammill; Lisa G Berdan; Tyrus Rorick; Salim Janmohamed; Zachary Lampron; Adrian F Hernandez; Lesley H Curtis Journal: Trials Date: 2021-07-19 Impact factor: 2.279
Authors: Kevin M Pantalone; Kashif Munir; Clinton M Hasenour; Charles M Atisso; Oralee J Varnado; Juan M Maldonado; Manige Konig Journal: Diabetes Obes Metab Date: 2020-09-06 Impact factor: 6.577