New data confirm Tresiba (insulin degludec) U200 delivers significantly lower rates of confirmed hypoglycaemia versus insulin glargine U100- Novo Nordisk

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 Lantus (insulin glargine) U100. Tresiba 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.

The 32-week, open-label, crossover, treat-to-target trial compared the safety, efficacy and patient-reported outcomes of insulin degludec 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 with insulin degludec U200, highlighting an overall preference versus insulin glargine U100. Patients receiving the more concentrated formulation of insulin degludec also reported numerically lower cases of nocturnal hypoglycaemia (p=not significant [ns]) and lower weight change (p=ns) and rated the delivery device FlexTouch significantly better for function compared to the insulin glargine U100 device.

After 16 weeks, the study demonstrated:

• Insulin degludec U200 delivered non-inferiority to insulin glargine U100 with respect to change in patient blood glucose levels
• Significantly reduced mean fasting plasma glucose with insulin degludec U200 versus insulin glargine U100 (-0.82 mmol/L vs -0.05 mmol/L, p<0.05)
• Significantly lower confirmed hypoglycaemia rate with insulin degludec U200 versus insulin glargine U100 (estimated rate ratio [ERR]; 0.59, p<0.05)
• Insulin degludec U200 delivered numerically lower nocturnal hypoglycaemia rate versus insulin glargine U100 (ERR; 0.66, p=ns)
• Lower mean weight change with insulin degludec U200 versus insulin glargine U100 (0.42kg vs 1.04kg, p=ns)
• Insulin degludec U200’s delivery device was rated significantly better for function (estimated treatment difference [ETD]: 8.40, p<0.05) and less bother (ETD: 6.01, p<0.05) compared to that of insulin glargine U100

In addition, similar adverse event (246 vs. 260) and serious adverse event (9 vs. 12, p=ns) rates per 100 patient-years of exposure were observed in the insulin degludec U200 arm versus insulin glargine U100. Only one patient withdrew due to an adverse event (insulin glargine U100).