Tresiba® ▼(insulin degludec) demonstrates significantly lower rates of hypoglycaemia vs insulin glargine U100

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Novo Nordisk

12 Jun, 2016, 23:01 GMT

LONDON, June 13, 2016 /PRNewswire/ --

This press release is intended for UK medical media only.

New results from two Phase 3b trials have shown that type 1 and type 2 diabetes patients treated with Tresiba® (insulin degludec) experience significantly lower rates of several types of hypoglycaemia, compared with patients treated with insulin glargine U100[1],[2] .

The findings are important for people with diabetes, as fear of hypoglycaemia or 'hypos' is a common problem and a feeling that is often shared by their friends and loved ones[3]. On average, people with type 1 diabetes experience two episodes of symptomatic hypoglycaemia per week and for people with type 2 diabetes, at least one episode per fortnight, with almost 50% of all types of hypos occurring during the night[4]-[6]. Hypos range from mild to severe and can greatly impact quality of life, affecting people's sleep patterns, their relationships and their ability to work[7]-[9].

The results from the SWITCH, treat to target, trials - the first-ever double-blinded, crossover basal insulin studies - assessing the safety and efficacy of insulin degludec compared to insulin glargine U100 in patients at high risk of hypoglycaemia with type 1 diabetes (SWITCH 1) and type 2 diabetes (SWITCH 2), were presented over the weekend at the 76th annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, USA.

Dr Simon Heller, Professor of Clinical Diabetes at Sheffield University said: "Hypoglycaemia is a common concern for patients I see treated with insulin, particularly night-time episodes that are harder to detect and manage. The SWITCH results add important new evidence to the overall body of data supporting the use of insulin degludec for people living with type 1 or type 2 diabetes who experience problematic hypoglycaemia - and provide additional clinical approaches in this important group of patients."

In SWITCH 1, type 1 diabetes patients on insulin degludec showed[1]:

  • Significantly lower rates of severe or blood-glucose confirmed symptomatic hypoglycaemia versus insulin glargine U100 in the maintenance period
  • Significantly lower number of severe of blood-glucose confirmed symptomatic nocturnal hypoglycaemia (occurring between the hours of 00:01-05:59) in the maintenance period
  • Significantly reduced rate of severe hypoglycaemia in the maintenance period and across total treatment period
  • Superiority to insulin glargine U100 regarding a lower proportion of patients experiencing severe hypoglycaemia during maintenance and total treatment periods
  • HbA1c non-inferiority of insulin degludec versus insulin glargine U100 at week 32 (6.95 vs 6.92%) and week 64 (6.95 vs. 6.97%)

In SWITCH 2, type 2 diabetes patients on insulin degludec showed[2]:

  • Significantly lower rates of severe or blood-glucose confirmed symptomatic hypoglycaemia during the maintenance period
  • Significantly lower number of severe or blood-glucose confirmed symptomatic nocturnal hypoglycaemia (occurring between the hours of 00:01-05:59) versus insulin glargine U100, during the maintenance period
  • Similar rates of severe hypoglycaemia during the maintenance period versus insulin glargine U100 (significantly lower in the full treatment period)
  • HbA1c non-inferiority of insulin degludec versus insulin glargine U100

In the trials, insulin degludec was well-tolerated. Adverse events were comparable between the two treatment arms across both trials. The most common adverse events were nasopharyngitis and upper respiratory tract infections and hypoglycaemia[1],[2].

 

NOTES TO EDITORS 

About SWITCH 1 and SWITCH 2 

The two 2 x32-weeks randomised, double-blind, cross-over, treat-to-target trials were initiated in January 2014 with purpose of comparing the safety and efficacy of Tresiba® and insulin glargine U100 in patients at risk of hypoglycaemia. The overall purpose of the trials is to document the hypoglycaemia profile in type 1 diabetes and type 2 diabetes respectively, compared to insulin glargine U100. In SWITCH 1, 501 people with type 1 diabetes were randomised to crossover treatment with Tresiba® and insulin glargine U100 in combination with insulin aspart. In SWITCH 2, 721 people with type 2 diabetes were randomised to crossover treatment with Tresiba® and insulin glargine U100 in combination with oral antidiabetics.

About Tresiba®  

Tresiba® (insulin degludec) is a once-daily basal insulin that provides duration of action beyond 42 hours[10],[11]. It is important for people with type 1 and type 2 diabetes to establish a routine for insulin treatment. On occasions when administration at the same time of day is not possible, insulin degludec allows for flexibility in day-to-day dosing time when needed[10],[12],[13]. A minimum of 8 hours between injections should be ensured.

Insulin degludec received its first regulatory approval in September 2012 and has since been approved in more than 60 countries globally.

About Novo Nordisk 

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders, and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 41,600 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.co.uk. 

Further information

Stephen Cull
+44-(0)-7584-447-280
scul@novonordisk.com

Rupal Patel
+44-(0)-7870-678-084
rupal.patel@packerforbes.com

Jade McCudden
+44-(0)-7424-410-749
jade.mccudden@packerforbes.com

References 

  1. Lane W, et al. SWITCH 1: Reduced hypoglycaemia with insulin degludec (IDeg) vs insulin glargine (IGlar), both U100, in patients with T1D at high risk of hypoglycaemia: a randomized, double-blind, crossover trial. Poster presented at the 76th Scientific Sessions of the American Diabetes Association (ADA). June 2016.
  2. Wysham C, et al. SWITCH 2: Reduced hypoglycaemia with insulin degludec (IDeg) vs insulin glargine (IGlar), both U100, in patients with T2D at high risk of hypoglycaemia: a randomized, double-blind, crossover trial. Poster presented at the 76th Scientific Sessions of the American Diabetes Association (ADA). June 2016.
  3. Diabetes.co.uk Fear of Hypoglycaemia. Available at: http://www.diabetes.co.uk/fear-of-hypoglycemia.html. Last accessed June 2016.
  4. McCrimmon R and Sherwin R. Hypoglycemia in Type 1 Diabetes. Diabetes. 2010; 59(10): 2333-2339.
  5. Diabetes UK. Survey reveals hidden incidence of 'hypos' among people with type 2 diabetes. Available at: https://www.diabetes.org.uk/About_us/News_Landing_Page/Survey-reveals-hidden-incidence-of-hypos-among-people-with-Type-2-diabetes/. Last accessed June 2016.
  6. Allen K and Frier B. Nocturnal hypoglycemia: clinical manifestations and therapeutic strategies toward prepisodeion. Endocr Pract 2003; 9(6):530-43.
  7. Diabetes World Awake Study. Conducted by Aequus August 2013. Funded by Novo Nordisk A/S.
  8. Kovacs Burns K, et al. Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national benchmarking indicators for family members living with people with diabetes. Diabet Med 2013 Jul; 30(7):778-88.
  9. Brod M, et al. The impact of non-severe hypoglycemic episodes on work productivity and diabetes management. Value Health 2011; 14(5):665-71.
  10. Tresiba® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/medicine/27363. Last accessed June 2016
  11. Haahr H and Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet 2014;53:787-800.
  12. 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.
  13. 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.