Ryzodeg® Significantly Reduces the Risk of Low Blood Sugar in People With Type 2 Diabetes who Fast During Ramadan

Abu Dhabi, Uae (ots/PRNewswire) -

In people with type 2 diabetes who fast during Ramadan, Ryzodeg®
(insulin degludec/insulin aspart) reduced the overall rate of low
blood sugar (hypoglycaemia) including severe episodes by 62% and the
rate of nocturnal hypoglycaemia by 74% versus biphasic insulin aspart
30 (BIAsp 30 [NovoMix® 30]). The trial results were presented today
at the International Diabetes Federation Congress 2017 (IDF 2017).[1]

"Millions of people with type 2 diabetes participate in Ramadan
every year and we know that periods of prolonged fasting can increase
the risk of hypoglycaemia," said lead investigator Dr Mohamed
Hassanein of the Dubai Hospital, Dubai Health Authority, UAE and
chair of the Diabetes and Ramadan International Alliance (DAR). "This
highlights the importance of people with type 2 diabetes preparing
for Ramadan with their doctor and discussing treatment options for
preventing episodes of hypoglycaemia."

It is estimated that worldwide over 116 million Muslims with
diabetes may choose to fast during Ramadan.[2] Muslims with type 2
diabetes who fast during Ramadan have up to a 7.5-fold increased risk
of severe hypoglycaemia.[3]

"This trial has shown that Ryzodeg® is not only a simple treatment
option which can make daily life easier for people with diabetes.
Ryzodeg® also reduces the risk of potentially dangerous episodes of
hypoglycaemia in people with type 2 diabetes who choose to fast
during Ramadan," said Mads Krogsgaard Thomsen, executive vice
president and chief science officer of Novo Nordisk.

The trial was designed to investigate the effects of Ryzodeg® on
blood sugar control and hypoglycaemia reduction versus BIAsp 30, both
at the end of Ramadan and 4 weeks post-Ramadan. There was no
difference in overall blood sugar control between Ryzodeg® and BIAsp
30.[1]

About the trial

The Ramadan trial compared the efficacy and safety of Ryzodeg®
twice daily and BIAsp 30 (NovoMix®) twice daily in subjects with type
2 diabetes before, during and after Ramadan. The trial was a 28-week,
international, open-label, randomised, treat-to-target trial
involving 263 adults from five countries with large Muslim
populations (Algeria, India, Lebanon, Malaysia and South Africa). The
primary endpoint was change in HbA1c from baseline to the end of the
month of Ramadan (four-week period). Secondary confirmatory endpoints
included rates of blood sugar confirmed, nocturnal and severe
hypoglycaemia.[1]

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 an ultra-long
duration of action and a mealtime insulin in one pen for people with
type 1 and 2 diabetes.[4]-[6] Ryzodeg® incorporates the benefits of
the degludec molecule.[7],[8] Ryzodeg® is given as an injection once
or twice daily with the main meal(s).[4] Ryzodeg® offers a simpler
regimen with fewer injections than basal and bolus therapy, in one
pen.[9]

Ryzodeg® received its first regulatory approval in December 2012
and European Medicines Agency approval in January 2013. Since then,
Ryzodeg® has been approved in more than 70 countries, including the
US in September 2015. It is now commercially available in 13
countries.[4]

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 obesity, haemophilia, growth disorders and other
serious chronic diseases. Headquartered in Denmark, Novo Nordisk
employs approximately 41,700 people in 77 countries and markets its
products in more than 165 countries. For more information, visit
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)

Further information

Media:
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
Hanna Ögren +45 3079 8519 haoe@novonordisk.com
Anders Mikkelsen +45 3079 4461 armk@novonordisk.com
Christina Kjær +45 3079 3009 cnje@novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj@novonordisk.com

References

1. Hassanein M, Echtay A, Malek R, et al. Efficacy and safety
of insulin degludec/insulin aspart in adults with type 2 diabetes
fasting during Ramadan. Presented at the International Diabetes
Federation Congress 2017, Abu Dhabi, UAE. 4-8 December 2017.

2. International Diabetes Federation and the Diabetes and
Ramadan (DAR) International Alliance. Diabetes and Ramadan: Practical
Guidelines. Brussels, Belgium: International Diabetes Federation,
2016. Available at: https://www.idf.org/e-library/guidelines/87-diabe
tes-and-ramadan-practical-25. Last accessed: November 2017.

3. Salti I, Benard E, Detournay B, et al. A population-based
study of diabetes and its characteristics during the fasting month of
Ramadan in 13 countries: results of the epidemiology of diabetes and
Ramadan 1422/2001 (EPIDIAR) study. Diabetes Care. 2004;27:2306-2311.

4. EMA. Ryzodeg® Summary of Product Characteristics. Available
at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produ
ct_Information/human/002499/WC500139011.pdf. Last accessed: November
2017.

5. Fulcher GR, Christiansen JS, Bantwal G, et al. 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;37:2084-2090.

6. De Rycke A, Mathieu C. Degludec - first of a new generation
of insulins. European Endocrinology. 2011;7:84-87.

7. Haahr H, Heise T. A review of the pharmacological properties
of insulin degludec and their clinical relevance. Clinical
Pharmacokinetics. 2014;53:787-800.

8. Marso SP, McGuire DK, Zinman B, et al. Efficacy and Safety
of Degludec versus Glargine in Type 2 Diabetes. N Engl J Med.
2017;377:723-732.

9. Heise T, Tack CJ, Cuddihy R, et al. A new-generation
ultra-long-acting basal insulin with a bolus boost compared with
insulin glargine in insulin-naïve people with type 2 diabetes: a
randomized, controlled trial. Diabetes Care. 2011;34:669-674.

ots Originaltext: Novo Nordisk A/S
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