In June 2017, Novo Nordisk (NVO) presented results from the DEVOTE trial, which was conducted to evaluate the safety and efficacy of Tresiba (insulin deglidec injection) compared to insulin glargine U100 in adults with type 2 diabetes mellitus and at high risk of cardiovascular disease. In the trial, 7,637 individuals with type 2 diabetes were randomized to either Tresiba therapy or insulin glargine U100 along with the standard of care.
Tresiba achieved the primary endpoint of non-inferiority versus insulin glargine U100 for major adverse cardiovascular events (or MACE). Further, all components of MACE were consistent with the primary endpoint. The trial showed a hazard ratio of 0.85 for cardiovascular death, 0.85 for non-fatal myocardial infarction, and 0.90 for non-fatal stroke. Tresiba’s safety profile was consistent with previous clinical trials with the drug.
In June 2017, Novo Nordisk demonstrated that patients switching to Tresiba achieved significant reductions in glucose and lower rates of hypoglycemia. The EU-TREAT trial demonstrated that type 1 and type 2 diabetes patients who, after six months from switching from another basal insulin or insulin glargine or insulin detemir to Tresiba, experienced significant reductions in HbA1c. Type 1 and type 2 diabetes patients who, after six months from switching to Tresiba, showed a 0.20% and 0.50% reduction in HbA1c, respectively. The results of the EU-TREAT trial remained consistent at 12 months. Type 1 and type 2 diabetes patients demonstrated 85.0% and 92.0% reductions, respectively, in the rate of severe hypoglycemia.
The DEVOTE trial also demonstrated that patients who switched to the Tresiba therapy had a significant reduction in fasting plasma glucose. Type 1 and type 2 diabetes patients had -18.7 mg/dL (milligrams per deciliter) and -23.7 mg/dL reductions, respectively, in fasting plasma glucose. The real world superior clinical trial statistics could significantly boost the marketing capabilities of Tresiba around the world.
Novo Nordisk’s peers in the diabetes care drugs market include Sanofi (SNY), Merck & Co. (MRK), Astra Zeneca, Eli Lilly (LLY), and Johnson & Johnson. Growth in sales of Novo Nordisk’s Tresiba could boost the share prices of the Vanguard FTSE All-World ex-US ETF (VEU). Novo Nordisk makes up ~0.36% of VEU’s total portfolio holdings.