BAGSVÆRD, Denmark, September 1, 2014 /PRNewswire/ --
Novo Nordisk today announced that in Mexico, as the first country in the world, Ryzodeg® is now launched and made available for people with type 2 diabetes. 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 well-established mealtime insulin in one pen for people with type 2 diabetes-.
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Ryzodeg® offers adults with type 2 diabetes successful reductions in HbA1c,-, with lower risk of hypoglycaemia versus biphasic insulin aspart 30,[*]. As Ryzodeg® is a combination product it requires fewer daily injections than administering basal and mealtime insulin in separate injections.
"Ryzodeg® is a new approach to diabetes management, and we are very pleased to make it available now for people with diabetes. Ryzodeg® has documented excellent glucose control and a low risk of hypoglycaemia in clinical trials, and it represents an excellent opportunity for intensification of insulin treatment with fewer injections than other treatment options," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
*From two multinational trials comparing Ryzodeg® with biphasic insulin aspart 30 in previous insulin-using and insulin-naïve patients,.
Type 2 diabetes is a progressive disease, which means some patients will need to eventually intensify insulin treatment by adding mealtime insulin - bolus therapy - to achieve or maintain their glycaemic targets over time. Studies have shown that more than 50% of people with type 2 diabetes on basal insulin are not achieving their glycaemic targets as measured by HbA1c-.
Complications from diabetes caused by failing to keep optimal glycaemic control can be serious, and may include problems such as heart disease, stroke, blindness, kidney disease, nerve damage and premature mortality,. In Mexico, where 8.7 million people live with diabetes, the number of diabetes-related deaths was 70,281 in 2013.
Novo Nordisk expects to make Ryzodeg® available in additional countries around the world within the next year.
In a multinational trial, Ryzodeg® (insulin degludec/insulin aspart) delivered twice daily at main meals offered a successful reduction in HbA1c,with lower risk of hypoglycaemia versus biphasic insulin aspart 30 in people with type 2 diabetes, showing a:
- 32% lower risk of overall confirmed hypoglycaemia
- 73% lower risk of nocturnal confirmed hypoglycaemia
In other studies no apparent differences were shown between Ryzodeg® and its comparators, with respect to adverse events and standard safety parameters,,,.
Ryzodeg® has been approved in Aruba, Brazil, Chile, Costa Rica, El Salvador, the EU, Hong Kong, Iceland, India, Israel, Japan, Kazakhstan, Macedonia, Mexico, Norway, Russia, South Korea and Switzerland.
About the clinical trial programme
The clinical trial programmes for insulin degludec (BEGIN®) and Ryzodeg® (BOOST®) comprise the largest in the field of insulin therapy, including more than 11,000 people. Novo Nordisk completed the phase 3a BOOST® programme in 2010. This programme consisted of six randomised, controlled, treat-to-target trials in more than 30 countries. More than 2000 people were included in the development programme. The programme was designed after consultancy with regulatory agencies in Europe, Japan and USA.
About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 40,700 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com.
- Ryzodeg® Summary of Product Characteristics (SPC). Bagsværd, Denmark, Novo Nordisk A/S; February 2014.
- De Rycke A, et al. Degludec - first of a new generation of insulins. European Endocrinology. 2011;7:84-7.
- Fulcher 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;37:2084-90.
- Franek E, et al. Insulin degludec/insulin aspart (IDegAsp) provides superior FPG control and reduced hypoglycaemia vs. biphasic insulin aspart 30 (BIAsp 30) in insulin-naive adults with type 2 diabetes in a randomized phase 3 trial. Diabetes. 2014;63(Suppl.1):A225 (abstract 882-P).
- Christiansen JS, et al. Superior FPG control and less nocturnal hypoglycaemia with IDegAsp vs BIAsp 30 in Asian subjects poorly controlled on basal or pre/self-mixed insulin: randomised phase 3 trial. Diabetologia. 2013;56(Suppl.1):S420 (abstract 1045).
- Inzucchi SE, et al. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2012;55:1577-96.
- Dale J, et al. Insulin initiation in primary care for patients with type 2 diabetes: 3-year follow-up study. Prim Care Diabetes. 2010;4:85-9.
- Giugliano D, et al. Efficacy of Insulin Analogs in Achieving the Hemoglobin A1c Target of <7% in Type 2 Diabetes. Diabetes Care. 2011;34:510-7.
- Blak BT, et al. A retrospective database study of insulin initiation in patients with Type 2 diabetes in UK primary care. Diabet Med. 2012;29:e191-8.
- Imran SA, et al. Clinical practice guidelines: targets for glycaemic control. Can J Diabetes. 2013;37(Suppl.1):S31-4.
- Diabetes UK. Diabetes in the UK 2010: Key statistics on diabetes. Available at: http://www.diabetes.org.uk/Documents/Reports/Diabetes_in_the_UK_2010.pdf Last accessed June 2014.
- International Diabetes Federation. Diabetes Atlas. Sixth Edition. 2013. Available at http://www.idf.org/diabetesatlas Last accessed August 2014.
- Barquera S. et al. Diabetes in Mexico: cost and management of diabetes and its complications and challenges for health policy. Global Health. 2013;9:3.
- Hirsch IB, et al. Insulin degludec/insulin aspart administered once daily at any meal, with insulin aspart at other meals versus a standard basal-bolus regimen in patients with type 1 diabetes: a 26-week, phase 3, randomized, open-label, treat-to-target trial. Diabetes Care. 2012;35:2174-81.
- Onishi Y, et al. Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial. Diabetes Obes Metab. 2013;15:826-32.
Kasper Roseeuw Poulsen
Jannick Lindegaard Denholt
Frank Daniel Mersebach (US)
CVR no: 24 25 67 90
ZINC ID: HQMMA/RY/0714/0031
Date of approval: August 2014
SOURCE Novo Nordisk A/S