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