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Published on 15 September 2015

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New data confirm Tresiba® U200 delivers significantly lower rates of confirmed hypoglycaemia

New data presented today 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. (1) 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.

 

New data presented today 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. (1) 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.

 

These findings provide valuable insights to physicians treating patients with type 2 diabetes, many of whom require higher doses of insulin,” commented Dr Mark Warren, lead study investigator. “The 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 with Tresiba® U200, highlighting an overall preference versus insulin glargine U100. Patients receiving the more concentrated formulation of Tresiba® 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. (1)

 

Dr Simon Heller, Professor of Clinical Diabetes at Sheffield University, commented: “These new data show that Tresiba® U200 significantly lowers both rates of hypoglycaemia and mean fasting blood glucose compared to insulin glargine U100. Interestingly, data for patient-reported outcomes also tell us that the delivery device function, as well as the prospect of fewer injections, are factors that matter to patients.
Patient choice forms a key element in the successful uptake of any diabetes treatment and the data for patient-reported outcomes reinforce the idea that individual preferences should be carefully considered, alongside efficacy, when selecting a treatment regimen.

 

After 16 weeks, the study demonstrated: (1)

  • Tresiba® U200 delivered non-inferiority to insulin glargine U100 with respect to change in patient blood glucose levels
  • Significantly reduced mean fasting plasma glucose with Tresiba® U200 versus insulin glargine U100 (-0.82 mmol/l versus -0.05 mmol/l, p<0.05)
  • Significantly lower confirmed hypoglycaemia rate with Tresiba® U200 versus insulin glargine U100 (estimated rate ratio [ERR]; 0.59, p<0.05)
  • Tresiba® U200 delivered numerically lower nocturnal hypoglycaemia rate versus insulin glargine U100 (ERR; 0.66, p=ns)
  • Lower mean weight change with Tresiba® U200 versus insulin glargine U100 (0.42kg versus 1.04kg, p=ns)
  • Tresiba® 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 versus 260) and serious adverse event (9 versus 12, p=ns) rates per 100 patient-years of exposure were observed in the Tresiba® U200 arm versus insulin glargine U100. Only one patient withdrew due to an adverse event (insulin glargine U100). (1)

 

References:

  1. 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.
  2. Tresiba® Summary of Product Characteristics. Bagsværd, Denmark, Novo Nordisk A/S; June 2015.
  3. Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet 2014;53:787–800.
  4. Meneghini L et al. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily. Diabetes Care 2013;36:858–64.
  5. Mathieu C et al. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension. J Clin Endocrinol Metab 2013;98:1154–62.


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