Tresiba demonstrated significantly improved blood sugar control and lower rates of hypoglycaemia versus insulin glargine U300 in CONFIRM real-world evidence study.- Novo Nordisk.

Adults with type 2 diabetes treated with Tresiba (insulin degludec injection) from Novo Nordisk had a significant reduction in HbA1c and a 30% lower rate of hypoglycaemic episodes after starting basal insulin. Findings from CONFIRM - a large real-world evidence (RWE) study comparing the effectiveness of Tresiba (insulin degludec injection) versus insulin glargine U300 - will be presented on Monday, 25 June 2018 at the American Diabetes Association's 78th Scientific Sessions (ADA) in Orlando, US.

The retrospective, non-interventional comparative effectiveness study, which included more than 4,000 adults with type 2 diabetes who were starting basal insulin for the first time, showed that after six months those treated with Tresiba had significantly lower HbA1c compared to those treated with insulin glargine U300 (-1.5% vs. -1.2% respectively; p=0.029). As a secondary endpoint, there was a 30% lower rate of hypoglycaemic episodes with Tresiba compared to insulin glargine U300 (p=0.045). In this study, hypoglycaemic events, ranging from mild to severe, were registered using the International Classification of Diseases (ICD) codes 9/10 following diagnosis from a physician. This real-world study also showed in another secondary endpoint that people treated with Tresiba were more likely to stay on their treatment. Those treated with insulin glargine U300 had a 37% higher rate of discontinuing treatment after two years (p<0.001).

The CONFIRM study is a retrospective, non-interventional comparative effectiveness study that investigated Tresiba and insulin glargine U300 (Toujeo) in 4,056 insulin-naïve (defined as no evidence of basal insulin use at least 365 days prior to index date) adults with type 2 diabetes in the US. Study groups were equal in size (n=2,028) and patients in each group were comparable after matching for baseline characteristics. Patients were uncontrolled on one or more oral antidiabetic drugs or a GLP-1 (glucagon-like peptide-1) receptor agonist and prescribed Tresiba or insulin glargine U300 according to local practice. Electronic health records were sourced from multiple health systems in the US. The primary endpoint was change in HbA1c (blood sugar control) from baseline to six months follow-up. Secondary endpoints included rate of hypoglycaemia, proportion of patients with at least one hypoglycaemic episode and the rate of treatment discontinuation. As with all real-world studies, CONFIRM was not randomised and it carries the limitations of real-world evidence. This includes potential under-reporting of hypoglycaemia (however, this is the case in both treatment arms in CONFIRM meaning that the rate ratio as well as the odds ratio are expected to be preserved), and the short follow-up period of 3-6 months (though this corresponds to when the largest changes in HbA1c tend to occur and is commonly used in many trials). Additionally, in CONFIRM there is only evidence of prescribed basal insulin and not actual use (whether the medication was picked up at the pharmacy).