Ryzodeg(R) Delivers Significantly Lower Rates of Hypoglycaemia and Nocturnal Hypoglycaemia in a Broad Range of Type 2 Diabetes Patients

PR62717

VANCOUVER, British Columbia, Dec. 2/PRNewswire=KYODO JBN/ --

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                           Abstracts 0336-P, 0337-P, 0338-P

    New analyses demonstrate that Ryzodeg(R) (insulin degludec/insulin aspart)

achieved successful glycaemic control with significantly lower rates of

hypoglycaemia (low blood sugar) and nocturnal hypoglycaemia in patients with

type 2 diabetes versus BIAsp 30 and/or a basal-bolus regimen of insulin

degludec and insulin aspart[1]-[3]. These findings were presented today at the

23rd World Diabetes Congress of the International Diabetes Federation (IDF).

    The analyses of pooled data from five clinical studies highlighted that

these benefits were delivered to patients irrespective of baseline HbA1c,

disease duration or body mass index (BMI)[1]-[3]. The results also revealed

that Ryzodeg(R) versus both comparators resulted in statistically significant

reductions in fasting plasma glucose (FPG), and a lower insulin dose with

significant differences in patients with BMI less than or equal to30 or a

disease duration longer than 10 years[1]-[3].

    "Managing hypoglycaemia while also achieving optimal glycaemic control are

important considerations when selecting a treatment regimen," commented Dr.

Helena Rodbard, presenting author of the analyses. "These findings are

especially relevant in the era of personalised medicine, and provide valuable

assistance to the clinical use of Ryzodeg(R) in patients with type 2 diabetes."

    These data are from the analyses of five 26-week treat-to-target phase 3a/b

clinical trials in people with type 2 diabetes.

    About the analyses  

    The post-hoc pooled analyses evaluated the efficacy and safety of

Ryzodeg(R) in controlling glycaemic parameters and rates of hypoglycaemia in

patients with type 2 diabetes stratified according to baseline HbA1c, disease

duration and body mass index (BMI). End of trial HbA1c, FPG, insulin dose and

confirmed and nocturnal confirmed hypoglycaemia were analysed in the

aforementioned patient categories, according to baseline characteristics

stratification: HbA1c (＜7.5%, greater than or equal to 7.5-＜8.5%, greater than

or equal to 8.5-＜9.0%, greater than or equal to 9.0%), FPG (＜5.5, ＞5.5-＜7.0,

＞7.0-＜10.0, ＞10.0 mmol/L), disease duration (less than or equal to 10 or ＞10

years) and BMI (less than or equal to 30 or ＞30 kg/m2)[1]-[3].

    About Ryzodeg(R)  

    Ryzodeg(R) is a combination of two distinct insulin analogues (insulin

degludec and insulin as part in the ratio of 70% and 30%) making it the first

combination of a basal insulin with a long duration of action and a

well-established mealtime insulin in one pen for people with type 2

diabetes[4]-[6]. Ryzodeg(R) delivers a simple regimen with fewer injections

than basal and bolus therapy[7].

    Ryzodeg(R) received its first regulatory approval in December 2012, and has

since been approved in more than 60 countries globally. Ryzodeg(R) was most

recently approved by the U.S. Food and Drug Administration on 25 September 2015

for the treatment of diabetes mellitus in adults and is currently commercially

available in India, Mexico and Bangladesh.

    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 other

serious chronic conditions: haemophilia, growth disorders and obesity.

Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in

75 countries and markets its products in more than 180 countries. For more

information, visit novonordisk.com [http://www.novonordisk.com ], Facebook

[http://www.facebook.com/novonordisk ], Twitter

[http://www.twitter.com/novonordisk ], LinkedIn

[http://www.linkedin.com/company/novo-nordisk ], YouTube

[http://www.Youtube.com/novonordisk ]  

    References

    1) Rodbard H et al. Insulin degludec/insulin aspart lowers fasting plasma

glucose and hypoglycaemia rates independent of baseline HbA1c. Presented at the

IDF World Diabetes Congress, Vancouver, Canada; 30 November - 4 December 2015.

    2) Rodbard H et al. Insulin degludec/insulin aspart lowers fasting plasma

glucose and hypoglycaemia rates independent of disease duration. Presented at

the IDF World Diabetes Congress, Vancouver, Canada; 30 November - 4 December

2015.

    3) Rodbard H et al. Insulin degludec/insulin aspart lowers fasting plasma

glucose and rates of hypoglycaemia irrespective of body mass index. Presented

at the IDF World Diabetes Congress, Vancouver, Canada; 30 November - 4 December

2015.

    4) Ryzodeg(R) Summary of Product Characteristics (SPC). Bagsvaerd, Denmark,

Novo Nordisk A/S; April 2015.

    5) Fulcher G, Christiansen JS, Bantwal G, et al; on behalf of the BOOST:

Intensify Premix I Investigators. 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(8):2084-2090.

    6) De Rycke A, Mathieu C. Degludec - first of a new generation of insulins.

European Endocrinology. 2011;7(2):84-87

    7) Cooper et al. Treatment intensification with IDegAsp BID vs IDeg OD plus

IAsp in insulin-treated patients with type 2 diabetes: a randomised, controlled

phase 3 trial. Diabetologia, 2014;57(Suppl 1):s69 (abstract147)

    SOURCE: Novo Nordisk