Novo Nordisk A/S

Ryzodeg® Delivers Significantly Lower Rates of Hypoglycaemia and Nocturnal Hypoglycaemia in a Broad Range of Type 2 Diabetes Patients

Vancouver, British Columbia (ots/PRNewswire) - This material is intended for global medical media only.

This material is not approved for Canadian journalists or Canadian audiences.

For journalistic assessment and preparation before publication.

Abstracts 0336-P, 0337-P, 0338-P

New analyses demonstrate that Ryzodeg® (insulin degludec/insulin aspart) achieved successful glycaemic control with significantly lower rates of hypoglycaemia (low blood sugar) and nocturnal hypoglycaemia in patients with type 2 diabetes versus BIAsp 30 and/or a basal-bolus regimen of insulin degludec and insulin aspart[1]-[3]. These findings were presented today at the 23rd World Diabetes Congress of the International Diabetes Federation (IDF).

The analyses of pooled data from five clinical studies highlighted that these benefits were delivered to patients irrespective of baseline HbA1c, disease duration or body mass index (BMI)[1]-[3]. The results also revealed that Ryzodeg® versus both comparators resulted in statistically significant reductions in fasting plasma glucose (FPG), and a lower insulin dose with significant differences in patients with BMI <=30 or a disease duration longer than 10 years[1]-[3].

"Managing hypoglycaemia while also achieving optimal glycaemic control are important considerations when selecting a treatment regimen," commented Dr. Helena Rodbard, presenting author of the analyses. "These findings are especially relevant in the era of personalised medicine, and provide valuable assistance to the clinical use of Ryzodeg® in patients with type 2 diabetes."

These data are from the analyses of five 26-week treat-to-target phase 3a/b clinical trials in people with type 2 diabetes.

About the analyses

The post-hoc pooled analyses evaluated the efficacy and safety of Ryzodeg® in controlling glycaemic parameters and rates of hypoglycaemia in patients with type 2 diabetes stratified according to baseline HbA1c, disease duration and body mass index (BMI). End of trial HbA1c, FPG, insulin dose and confirmed and nocturnal confirmed hypoglycaemia were analysed in the aforementioned patient categories, according to baseline characteristics stratification: HbA1c (<7.5%, >=7.5-<8.5%, >=8.5-<9.0%, >=9.0%), FPG (<5.5, >5.5-<7.0, >7.0-<10.0, >10.0 mmol/L), disease duration (<=10 or >10 years) and BMI (<=30 or >30 kg/m2)[1]-[3].

About Ryzodeg®

Ryzodeg® is a combination of two distinct insulin analogues (insulin degludec and insulin aspart in the ratio of 70% and 30%) making it the first combination of a basal insulin with a long duration of action and a well-established mealtime insulin in one pen for people with type 2 diabetes[4]-[6]. Ryzodeg® delivers a simple regimen with fewer injections than basal and bolus therapy[7].

Ryzodeg® received its first regulatory approval in December 2012, and has since been approved in more than 60 countries globally. Ryzodeg® was most recently approved by the U.S. Food and Drug Administration on 25 September 2015 for the treatment of diabetes mellitus in adults and is currently commercially available in India, Mexico and Bangladesh.

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 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com (http://www.novonordisk.com), Facebook (http://www.facebook.com/novonordisk), Twitter (http://www.twitter.com/novonordisk), LinkedIn (http://www.linkedin.com/company/novo-nordisk), YouTube (http://www.Youtube.com/novonordisk)

References

1. Rodbard H et al. Insulin degludec/insulin aspart lowers fasting 
   plasma glucose and hypoglycaemia rates independent of baseline 
   HbA1c. Presented at the IDF World Diabetes Congress, Vancouver, 
   Canada; 30 November - 4 December 2015.
2. Rodbard H et al. Insulin degludec/insulin aspart lowers fasting 
   plasma glucose and hypoglycaemia rates independent of disease 
   duration. Presented at the IDF World Diabetes Congress, Vancouver,
   Canada; 30 November - 4 December 2015.
3. Rodbard H et al. Insulin degludec/insulin aspart lowers fasting 
   plasma glucose and rates of hypoglycaemia irrespective of body 
   mass index. Presented at the IDF World Diabetes Congress, 
   Vancouver, Canada; 30 November - 4 December 2015.
4. Ryzodeg® Summary of Product Characteristics (SPC). Bagsværd, 
   Denmark, Novo Nordisk A/S; April 2015.
5. Fulcher G, Christiansen JS, Bantwal G, et al; on behalf of the 
   BOOST: Intensify Premix I Investigators. Comparison of insulin 
   degludec/insulin aspart and biphasic insulin aspart 30 in 
   uncontrolled, insulin-treated type 2 diabetes: a phase 3a, 
   randomized, treat-to-target trial. Diabetes Care. 
   2014;37(8):2084-2090.
6. De Rycke A, Mathieu C. Degludec - first of a new generation of 
   insulins. European Endocrinology. 2011;7(2):84-87
7. Cooper et al. Treatment intensification with IDegAsp BID vs IDeg 
   OD plus IAsp in insulin-treated patients with type 2 diabetes: a 
   randomised, controlled phase 3 trial. Diabetologia, 2014;57(Suppl 
   1):s69 (abstract147) 

Contact:

Katrine Sperling
+45-4442-6718
krsp@novonordisk.com
Åsa Josefsson
+45 3079 7708
aajf@novonordisk.com Investors: Peter Hugreffe Ankersen
+45 3075 9085
phak@novonordisk.com
Daniel Bohsen
+45 3079 6376
dabo@novonordisk.com
Melanie Raouzeos
+45 3075 3479
mrz@novonordisk.com
Kasper Veje
+45 3079 8519
kpvg@novonordisk.com

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