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

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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)

ots Originaltext: Novo Nordisk A/S
Im Internet recherchierbar: http://www.presseportal.de

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