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Novo Nordisk A/S (NVO)'s Ryzodeg® Offers Improved Glycemic Control With Significantly Lower Rates Of Hypoglycaemia Compared To Biphasic Insulin Aspart 30 In Adults With Type 2 Diabetes
12/3/2013 7:04:00 AM
Ryzodeg(R) Offers Improved Glycaemic Control With Significantly Lower Rates of Hypoglycaemia Compared to Biphasic Insulin Aspart 30 in Adults With Type 2 Diabetes
COPENHAGEN, Denmark, Dec. 3, 2013 /PRNewswire/ -- Data presented today at the World Diabetes Congress of the International Diabetes Federation (IDF) show that adults with type 2 diabetes achieved improved glycaemic control, significantly lower rates of overall and nocturnal confirmed hypoglycaemia for the full trial period, and a significantly lower rate of severe hypoglycaemia during the maintenance period (defined as week 16 onwards) with Ryzodeg(R) compared to biphasic insulin aspart 30, both administered twice-daily.
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Ryzodeg(R) is the first combination of two distinct insulin analogues, Tresiba(R) (insulin degludec), the once-daily basal insulin with an ultra-long duration of action, and the well-established mealtime insulin NovoRapid(R) (insulin aspart), in the ratio of 70% and 30%, in one pen for people with type 2 diabetes-.
"Type 2 diabetes is a progressive disease and many patients who are uncontrolled with basal insulin need to add mealtime insulin to achieve or maintain their glycaemic targets over time. As Ryzodeg(R) is a combination of two distinct insulins, a basal insulin with a long and steady action profile and a well-established mealtime insulin, it is a simple way for patients to add mealtime control with a reduced risk of overall and nocturnal confirmed, and severe hypoglycaemia," said lead investigator Gregory Fulcher, Royal North Shore Hospital, Sydney, Australia.
The multinational BOOST(TM) INTENSIFY PREMIXI trial was a 26-week, randomised, controlled open-label, treat-to-target trial comparing the efficacy and safety of Ryzodeg(R) and biphasic insulin aspart 30, both administered twice-daily with or without oral antidiabetic drugs in adult patients with type 2 diabetes previously treated with premixed or self-mixed insulin either once- or twice-daily.
Overall study results include:
-- Ryzodeg(R) achieved the primary endpoint of non-inferiority to biphasic insulin aspart 30 for mean change in HbA1c from baseline (estimated treatment difference [ETD] -0.03% points, 95% CI -0.18; 0.13).
-- Ryzodeg(R) achieved the secondary endpoint of superiority in lowering FPG compared withbiphasic insulin aspart 30(ETD -1.14 mmol/L, 95% CI -1.53; -0.76, p<0.001).
-- Final mean daily insulin dose was 11% lower for Ryzodeg(R) compared with biphasic insulin aspart 30 (1.08 U/kg versus 1.20 U/kg; estimated rate ratio [RR] 0.89, 95% CI 0.83; 0.96, p=0.002).
-- Significantly lower rates of overall confirmed (self-reported PG <3.1 mmol/L or severe episode requiring assistance) and nocturnalconfirmed hypoglycaemia (onset 00.01-05.59 hours) for Ryzodeg(R) versus biphasic insulin aspart 30 were reported.
o A 32% lower rate of overall confirmed hypoglycaemia(9.7 versus 14.0 episodes/patient/year, RR 0.68, 95%CI 0.52; 0.89, p=0.0049).
o A73% lower rate of nocturnalconfirmed hypoglycaemia (0.7 versus 2.5 episodes/patient/year; RR 0.27, 95% CI 0.18; 0.41, p<0.0001).
o A numerically lower rate of severe hypoglycaemia, although the difference was not significant (0.09 versus 0.25 episodes/patient/year, RR 0.50, 95% CI 0.19; 1.30, p=ns).
-- During the maintenance period (defined as week 16 onwards, a period when majority of patients achieve stable insulin dose and glycaemic control) significant differences were reported in rates of hypoglycaemia comparing Ryzodeg(R) with biphasic insulin aspart 30.
o A 39% lower rate of overallconfirmed hypoglycaemia(RR 0.61, 95% CI 0.45; 0.83, p=0.0015).
o A 77% lower rate of nocturnal confirmed hypoglycaemia(RR 0.23, 95% CI 0.13; 0.41, p<0.0001).
o An 89% lower rate of severe hypoglycaemia (RR 0.11, 95% CI 0.01; 0.91, p=0.04).
1.Fulcher G, et al. Insulin degludec/insulin aspart achieves superior FPG and less hypoglycaemia vs biphasic insulin aspart 30 in poorly controlled T2DM. Poster #1399, presented at International Diabetes Federation (IDF), World Diabetes Congress, Melbourne, December 2013.
2.Ryzodeg(R) Summary of Product Characteristics (SmPC). May 2013.
3.Jonassen I, et al. Ultra-long acting insulin degludec can be combined with rapid-acting insulin aspart in a soluble co-formulation. J Peptide Sci 2010;16(Suppl.1):32.
4.De Rycke A, et al. Degludec - first of a new generation of insulins. Eur Endocrinol 2011;7:84-7.
5.Fulcher G, et al. Superior FPG control and reduced hypoglycaemia with IDegAsp vs BIAsp 30 in adults with type 2 diabetes mellitus inadequately controlled on pre/self-mixed insulin: a randomised phase 3 trial. Diabetologia 2013;56(Suppl.1):S419-20 (abstract 1044).
6.Vaag A, et al. Lower rates of overall, nocturnal and severe hypoglycaemia during maintenance treatment with IDegAsp vs biphasic insulin aspart 30 in patients with type 2 diabetes mellitus: a meta-analysis. Diabetologia 2013;56(Suppl.1):S83 (abstract 187).
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Ryzodeg(R) is the global brand name forinsulin degludec/insulin aspart. It is a combination of two distinct insulin analogues, Tresiba(R) (insulin degludec) and NovoRapid(R) (insulin aspart) in the ratio of 70% and 30%. Ryzodeg(R) delivered twice-daily at main meals offers successful reductions in HbA1c with lower rates of hypoglycaemia versus biphasic insulin aspart 30 in people with type 2 diabetes,. Ryzodeg(R) has been approved in Japan, Mexico, EU, Norway, Iceland, Switzerland, El Salvador and Chile.
About the BOOST(TM) programme
Novo Nordisk completed the phase 3a BOOST(TM) programme in 2010. This programme consisted of six randomised, controlled, treat-to-target trials in more than 30 countries and comprised the majority of the data supporting the regulatory applications for Ryzodeg(R). More than 2000 people were included in the development programme. The programme was designed after consultancy with regulatory agencies in Europe and USA.
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 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. Headquartered in Denmark, Novo Nordisk employs approximately 37,000 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com.
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