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The American Diabetes Association and the European Association for the Study of Diabetes convened a panel to update the prior position statements, published in 2012 and 2015, on the management of type 2 diabetes in adults. A systematic evaluation of the literature since 2014 informed new recommendations. These include additional focus on lifestyle management and diabetes self-management education and support. For those with obesity, efforts targeting weight loss, including lifestyle, medication, and surgical interventions, are recommended. With regards to medication management, for patients with clinical cardiovascular disease, a sodium–glucose cotransporter 2 (SGLT2) inhibitor or a glucagon-like peptide 1 (GLP-1) receptor agonist with proven cardiovascular benefit is recommended. For patients with chronic kidney disease or clinical heart failure and atherosclerotic cardiovascular disease, an SGLT2 inhibitor with proven benefit is recommended. GLP-1 receptor agonists are generally recommended as the first injectable medication.

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LeaderT here is a demand from regulators that new treatments for the management of hyperglycaemia in people with type 2 diabetes should not increase cardio vascular risk. 1,2 For most new therapies this will include the performance of a dedicated randomised-controlled cardiovascular outcomes trial (CVOT). This can be conducted prior to licensing, like the SUSTAIN-6 trial with semaglutide, 3 or post-licensing, like the LEADER trial with liraglutide. 4 The results of CVOTs with albiglutide, a once-weekly GLP-1 receptor agonist, and linagliptin, a DPP-4 inhibitor, were presented at the recent meeting of the European Association for the Study of Diabetes (EASD) in Berlin. 5,6 As there are now several completed trials with GLP-1 receptor agonists and DPP-4 inhibitors it is relevant to place the results of these studies in the context of the results of previous studies. Harmony OutcomesAlbiglutide is a once-weekly GLP-1 receptor agonist composed of two copies of modified human GLP-1 fused to human albumin. It was available for clinical use in the US and Europe from 2014. In the summer of 2017 the manufacturer GlaxoSmithKline announced that albiglutide would be withdrawn from the worldwide market by 2018 for economic reasons that were not detailed, and marketing ceased in July 2018. A lack of potency compared to other GLP-1 receptor agonists, 7 and the inconvenience to the patient of having to reconstitute the lyophilised powder with a diluent and wait 15-30 minutes before injection 8 may have contributed to the low use of albiglutide in countries where other onceweekly GLP-1 receptor agonists were available.Harmony Outcomes was a post-licensing CVOT comparing albiglutide and placebo in 9463 people with type 2 diabetes and established cardiovascular disease, including coronary vascular disease, cerebrovascular disease and peripheral arterial disease. 5 Other inclusion criteria included age over 40 years, and HbA1c over 7.0% (53mmol/mol). At baseline 70% of participants had coronary heart disease, 47% had a previous myocardial infarction and 20% were recorded as having baseline heart failure by their local clinical investigator. Subjects were followed for a median of 1.6 years and the primary outcome was major adverse cardiovascular events (MACE), a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.Subjects in the albiglutide arm had a statistically significant 22% reduction in MACE compared to the placebo group. This was despite one-quarter of the subjects discontinuing therapy during this short study. Of the components of the MACE outcome, myocardial infarction (fatal or non-fatal) was significantly reduced, with insignificant effects on stroke and cardiovascular death. The number of subjects needed to treat with albiglutide for 1.6 years to prevent one major adverse cardiovascular event was 50. In the placebo group there was as expected a greater use of sulphonylureas and insulin, including greater use of bolus insulin. Hypoglycaemia rates were lower with albiglutide, including le...