New Study Confirms Tresiba (insulin degludec) U200 Delivers Significantly Lower Rates of Confirmed Hypoglycaemia Versus Insulin Glargine U100

STOCKHOLM, September 15, 2015

New data presented at the 51st annual meeting of the European Association for the Study of Diabetes (EASD) show that patients with type 2 diabetes receiving the U200 formulation of Tresiba (insulin degludec) experienced significantly lower rates of confirmed hypoglycaemia and significantly reduced mean fasting blood glucose compared to those receiving insulin glargine U100. Degludec U200 is twice as concentrated as U100, allowing patients to inject up to 160 units in a single injection, rather than in two separate injections.

he more concentrated formulation of Tresiba also means fewer injections, which will be a welcome option for those patients who require higher than 80 units.

The 32-week, open-label, crossover, treat-to-target trial compared the safety, efficacy and patient-reported outcomes of Tresiba U200 to insulin glargine U100 in patients who might benefit from a low-volume basal insulin. In the study, patients with type 2 diabetes also reported higher satisfaction,numerically lower cases of nocturnal hypoglycaemia and lower weight change with Tresiba U200, highlighting an overall preference versus insulin glargine U100.

After 16 weeks, the study demonstrated:

  • Tresiba U200 delivered non-inferiority to insulin glargine with respect to change in patient blood glucose levels
  • Significantly reduced mean fasting plasma glucose with Tresiba U200 versus insulin glargine (-0.82 mmol/L vs -0.05 mmol/L, p<0.05)
  • Significantly lower confirmed hypoglycaemia rate with Tresiba U200 versus insulin glargine (estimated rate ratio [ERR]; 0.59, p<0.05)
  • Tresiba U200 delivered numerically lower nocturnal hypoglycaemia rate versus insulin glargine (ERR; 0.66)
  • Lower mean weight change with Tresiba U200 versus insulin glargine (0.42 kg vs 1.04kg).

In addition, 32.1% of patients in the Tresiba U200 arm and 35.2% in the insulin glargine arm reported adverse events. Of these, 2.9% and 2.8% respectively were serious adverse events requiring third party intervention.

Source:

  1. Express pharma.
  2. Warren M, et al. Efficacy, patient reported outcomes and safety of insulin degludec U200 compared with insulin glargine in patients with type 2 diabetes (T2D) requiring high-dose insulin. Presented at the 51st annual meeting of the European Association for the Study of Diabetes (EASD); Stockholm, Sweden, 14-18 September 2015.