2017年12月7日

Novo Nordisk

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

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

PR71438

ABU DHABI, UAE, Dec. 7, 2017 /PRNewswire=KYODO JBN/ —

In people with type 2 diabetes who fast during Ramadan, Ryzodeg(R) (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(R)
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(R) is not only a simple treatment option
which can make daily life easier for people with diabetes. Ryzodeg(R) 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(R) 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(R) and BIAsp 30.[1]

About the trial

The Ramadan trial compared the efficacy and safety of Ryzodeg(R) twice daily
and BIAsp 30 (NovoMix(R)) 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(R)

Ryzodeg(R) 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(R) incorporates the benefits of the degludec molecule.[7],[8]
Ryzodeg(R) is given as an injection once or twice daily with the main
meal(s).[4] Ryzodeg(R) offers a simpler regimen with fewer injections than
basal and bolus therapy, in one pen.[9]

Ryzodeg(R) received its first regulatory approval in December 2012 and European
Medicines Agency approval in January 2013. Since then, Ryzodeg(R) 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, Twitter, LinkedIn, YouTube

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 Ogren             +45 3079 8519   haoe@novonordisk.com
    Anders Mikkelsen        +45 3079 4461   armk@novonordisk.com
    Christina Kjaer          +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-diabetes-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(R) Summary of Product Characteristics. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_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.

SOURCE: Novo Nordisk