Harmony Outcomes: A randomized, double-blind, placebo-controlled trial of the effect of albiglutide on major cardiovascular events in patients with type 2 diabetes mellitus—Rationale, design, and baseline characteristics

Jul 18, 2018American heart journal

Albiglutide’s impact on major heart problems in people with type 2 diabetes: study plan and participant details from a controlled trial

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Abstract

A total of 9,463 patients were enrolled in the Harmony Outcomes trial across 28 countries.

The trial is designed to evaluate the cardiovascular safety of albiglutide in patients with type 2 diabetes and established cardiovascular disease.
Participants have a mean age of 64.1 years and an average diabetes duration of 13.8 years, with a glycated hemoglobin level of 8.7%.
Seventy percent of the enrolled patients have a history of coronary artery disease, and a significant portion also has peripheral arterial disease (25.0%), stroke (17.7%), heart failure (20.2%), and chronic kidney disease (22.6%).
The trial aims to observe at least 611 confirmed major adverse cardiovascular events over a median follow-up of at least 1.5 years.

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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.

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Harmony Outcomes: A randomized, double-blind, placebo-controlled trial of the effect of albiglutide on major cardiovascular events in patients with type 2 diabetes mellitus—Rationale, design, and baseline characteristics

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