Xultophy(R) Demonstrates Similar Glucose Control with Reduced Risk of Hypoglycaemia and a Superior Weight Profile Compared to Basal-Bolus Therapy

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BAGSVAERD, Denmark, Dec. 2, 2016 /PRNewswire=KYODO JBN/--

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    Novo Nordisk today announced new phase 3b trial (DUAL VII) results with

Xultophy(R) (IDegLira). Xultophy(R) is a once-daily, single injection fixed

combination of a long-acting basal insulin (insulin degludec) and a

glucagon-like peptide-1 (GLP-1) receptor agonist (liraglutide).[1] The

open-label trial investigated the efficacy and safety of Xultophy(R) compared

with insulin glargine U100 in combination with insulin aspart at all main

meals, after 26 weeks of treatment in 506 adults with type 2 diabetes. [2],[3]

    The trial successfully achieved its objective by demonstrating that

treatment with Xultophy(R) is non-inferior to insulin glargine U100 in

combination with insulin aspart with regards to lowering of HbA1c. From a mean

baseline HbA1c of 8.2%, both patient groups reached a similar HbA1c level of

6.7% after 26 weeks of treatment. At the end of the trial,  people treated with

Xultophy(R) required 40.1 units compared to a total of 84.6 units of insulin

for people treated with insulin glargine U100 in combination with insulin

aspart. [3]

    People treated with Xultophy(R) showed a superior reduction of 89% in the

rate of severe or blood glucose confirmed symptomatic hypoglycaemic episodes

compared to insulin glargine U100 in combination with insulin aspart.

Furthermore, from a mean baseline body weight of 87.7 kg, people treated with

Xultophy(R) experienced weight loss of 0.9 kg compared with weight gain of 2.6

kg for people treated with the basal-bolus regimen; a superior weight

difference of -3.6 kg.[3]

    "We are excited about the results of DUAL VII, showing the important

benefits Xultophy (R) offers for people inadequately controlled on insulin

glargine U100 as an alternative to intensification with basal-bolus therapy"

said Mads Krogsgaard Thomsen, executive vice president and chief science

officer, Novo Nordisk A/S. "Xultophy(R) shows these impressive results,

including reduction in hypoglycaemia and body weight, with a much lower dose

compared to insulin glargine U100 in combination with insulin aspart at the end

of the study."

    The safety profile of Xultophy(R) in DUAL VII was generally consistent with

previous Xultophy(R) clinical trials.[3]

    The complete trial results will be presented in the first half of 2017.

    About Xultophy(R)

    Xultophy(R) is a once-daily single injection fixed combination of

long-acting insulin degludec (Tresiba(R)) and the GLP-1 receptor agonist

liraglutide (Victoza(R)). The maximum dose of Xultophy(R) is 50 dose steps

(equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide).[1]

Xultophy(R) has been investigated in seven trials in the DUAL clinical trial

programme, encompassing more than 4,000 people with type 2 diabetes. Phase 3b

trials are still ongoing. On 21 November 2016, Xultophy(R) was approved by the

FDA under the brand name Xultophy(R) 100/3.6.[4] On 18 September 2014,

Xultophy(R) was granted marketing authorisation by the European Commission and

approved in Switzerland on 12 September 2014.[1],[5]

    About DUAL VII

    DUAL VII was a phase 3b, 26-week, randomised, open-label, multicentre trial

conducted in 12 countries with 506 patients.[2],[3] The trial was designed to

investigate the safety and efficacy of Xultophy(R) vs basal-bolus therapy in

adults with type 2 diabetes previously treated with insulin glargine U100 and

metformin.[2]

    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 42,600 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 ]

        Further information

        Media: Katrine Sperling

               +45-4442-6718

               krsp@novonordisk.com;

               Michael Bachner (US)

               +1-609-786-7796

               mzyb@novonordisk.com;

   Investors: Peter Hugreffe Ankersen

              +45-3075-9085

              phak@novonordisk.com

              Melanie Raouzeos

              +45-3075-3479

              mrz@novonordisk.com

             Hanna Ogren

             +45-3075-8519

             haoe@novonordisk.com

             Anders Mikkelsen

             +45-3079-4461

             armk@novonordisk.com

             Kasper Veje (US)

             +1-609-235-8567

             kpvj@novonordisk.com

     References

    1. EMA. Xultophy(R) summary of product characteristics. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002647/WC500177657.pdf

Last accessed: November 2016.

    2. ClinicalTrials.gov. A Clinical Trial Comparing Efficacy and Safety of

Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects

With Type 2 Diabetes Mellitus. Available at:

https://clinicaltrials.gov/ct2/show/NCT02420262?term=ideglira%2C+basal-bolus&rank=1

Last accessed November 2016.

    3. Novo Nordisk, Data on file.

    4. Novo Nordisk. Novo Nordisk receives US FDA approval for Xultophy(R)

100/3.6. Available at:  http://www.novonordisk.com/bin/getPDF.2058006.pdf Last

accessed November 2016.

    5. SwissMedic. Xultophy(R): information for professionals. 2014.

    SOURCE: Novo Nordisk