2. Tresiba Proven Safe for the Heart with

Lower Risk of Hypoglycaemia

The full study results of Trial Comparing Cardiovascular Safety of Insulin Degludec versus Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) were presented at the 77th Scientific Sessions of American Diabetes Association (ADA). According to the new data, Insulin Degludec (Tresiba) was found to be cardio vascular safe as insulin glargine and was associated with much lower rates of severe hypoglycemia.

In the trial, 7637 patients with type 2 diabetes were randomized to receive either insulin degludec (n = 3818) or insulin glargine U100 (n = 3819) once daily between dinner and bedtime in a double-blind, treat-to-target fashion. The DEVOTE trial achieved its primary endpoint by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with insulin degludec compared with insulin glargine U100 when added to standard of care. The primary endpoint of the DEVOTE trial was defined as the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke and showed a hazard ratio of 0.91 in favour of insulin degludec relative to insulin glargine U100, with no statistically significant difference between the two treatments arms (0.91 [0.78; 1.06]95% CI, P<0.001 for non-inferiority).

There was similar reductions in HbA1c with insulin degludec compared with insulin glargine (mean HbA1c was 7.5±1.2% in each group at the end of trial), thus fulfilling the requirements for objectively comparing hypoglycaemia rates between the two treatments. A 40% significant reduction in the rate of adjudicated severe hypoglycaemia (Rate ratio: 0.60 [0.48; 0.76]95% CI P<0.001) and a 53% significant reduction in the rate of adjudicated nocturnal severe hypoglycaemia (Rate ratio: 0.47 [0.31; 0.73]95% CI P<0.001) with insulin degludec compared with insulin glargine was demonstrated.

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