PR55197

Ryzodeg(R) Offers Improved glycaemic Control With Significantly Lower Rates of Hypoglycaemia Compared to biphasic insulin aspart 30 in Adults With Type 2 Diabetes[1]

COPENHAGEN, Dec 3, 2013 /PRN=KYODO JBN/ --

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[1].

To view the Multimedia News Release, please click:

http://www.multivu.com/mnr/64158-ryzodeg-improved-glycaemic-control

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[2]-[4].

"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 andnocturnal 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[1]:

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.

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).

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).

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.

A 39% lower rate of overallconfirmed hypoglycaemia(RR 0.61, 95% CI 0.45; 0.83,

p=0.0015).

A 77% lower rate of nocturnal confirmed hypoglycaemia(RR 0.23, 95% CI 0.13;

0.41, p＜0.0001).

An 89% lower rate of severe hypoglycaemia (RR 0.11, 95% CI 0.01; 0.91, p=0.04).

About Ryzodeg(R)

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[2] with lower

rates of hypoglycaemia versus biphasic insulin aspart 30 in people with type 2

diabetes[5],[6]. 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.

Further information

Media:       

Katrine Sperling    

+45-4442-6718    

krsp@novonordisk.com

Ken Inchausti (US)    

+1-609-514-8316    

kiau@novonordisk.com

Investors:       

Kasper Roseeuw Poulsen    

+45-4442-4303    

krop@novonordisk.com

Frank Daniel Mersebach

Daniel Bohsen    

+45-4442-0604

+45-3079-6376    

fdni@novonordisk.com

dabo@novonordisk.com

Lars Borup Jacobsen    

+45-3075-3479    

lbpj@novonordisk.com

Jannick Lindegaard (US)    

+1-609-786-4575    

jlis@novonordisk.com

_______________________

References

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.

Ryzodeg(R) Summary of Product Characteristics (SmPC). May 2013.

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.

De Rycke A, et al. Degludec - first of a new generation of insulins. Eur

Endocrinol 2011;7:84-7.

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).

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).

SOURCE: Novo Nordisk