Significant Blood Sugar Improvement With Xultophy(R) Compared to Insulin Glargine U-100 When Used as Add-On to Oral Diabetes Medications

PR74114

BAGSVÆRD, Denmark, June 23, 2018 /PRNewswire=KYODO JBN/ --

     Oral Presentation #127-OR

    Adults with type 2 diabetes treated with Xultophy(R) (insulin degludec and

liraglutide injection) also experienced no change in body weight, lower rates

of hypoglycaemia and a lower insulin dose at 26 weeks

    Xultophy(R) (insulin degludec and liraglutide injection) provided superior

blood sugar reduction (HbA1c) compared to insulin glargine U-100 (1.94% vs

1.68% respectively; p<0.0001) when used as an add-on to an SGLT-2i (an

oral diabetes medication), according to results from the DUAL IX study

presented today at the American Diabetes Association's 78th Scientific Sessions

(ADA) in Orlando, US.1

    Results from some of the secondary endpoints in DUAL IX included change

from baseline in body weight, severe or blood glucose confirmed symptomatic

hypoglycaemic events and daily insulin dose at 26 weeks. Mean body weight

remained unchanged in the Xultophy(R) study group versus a 2.0 kg weight gain

with insulin glargine U-100. Treatment with Xultophy(R) demonstrated a 58%

lower rate of hypoglycaemia versus insulin glargine U-100 (0.37

events/patient-year of exposure vs 0.90 events/patient-year of exposure

respectively; p=0.0035). The average total daily insulin dose was significantly

less with Xultophy(R) than insulin glargine U-100 (36 units per day vs 54 units

per day respectively; p<0.0001).1

    "Type 2 diabetes is a progressive disease that often requires treatment

intensification," said Dr Athena Philis-Tsimikas, DUAL IX lead investigator and

corporate vice president, Scripps Whittier Diabetes Institute. "Xultophy(R) may

be an appropriate treatment option for those adults who are unable to meet

their blood sugar goals on their current medication."

    Adverse events were similar across both treatment groups; the most common

adverse events (greater than or equal to 5%) in the Xultophy(R) treated

patients included viral upper respiratory tract infection, headaches, back

pain, increased lipase and nausea. The safety profile of Xultophy(R) in DUAL IX

was consistent with previous Xultophy(R) clinical trials.1

    Additional DUAL IX patient-reported outcomes will be presented on Monday 25

June at ADA:

    - Patient-Reported Outcomes for Insulin Degludec/Liraglutide (IDegLira) vs

Insulin Glargine (IGlar U-100) as Add-On to Sodium-Glucose Co-Transporter-2

Inhibitor (SGLT2i) plus or minus Oral Antidiabetic Drug (OAD) Therapy in

Patients with Type 2 Diabetes: DUAL IX Trial (Poster Presentation 101-LB)

    About DUAL IX

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

conducted in 11 countries including 420 patients. The trial was designed to

investigate the safety and efficacy of Xultophy(R) versus insulin glargine

U-100 as add-on therapy in adults uncontrolled on sodium-glucose

co-transporter-2 inhibitor (SGLT-2i) treatment with or without additional oral

antidiabetic drug therapy.2 A hypoglycaemic event in DUAL IX was defined as an

event requiring assistance from another person or blood glucose (BG) confirmed

(less than 56 mg/dL) with symptoms consistent with hypoglycaemia.

    About Xultophy(R)

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

degludec, a long-acting human insulin analogue, and liraglutide, a

glucagon-like peptide 1 (GLP-1) receptor agonist. In Europe, Xultophy(R) is

indicated for the treatment of adults with insufficiently controlled type 2

diabetes mellitus to improve glycaemic control as an adjunct to diet and

exercise in addition to other oral medicinal products for the treatment of

diabetes.3

    In the US, Xultophy(R) is called Xultophy(R) 100/3.6, and is indicated as

an adjunct to diet and exercise to improve glycaemic control in adults with

type 2 diabetes inadequately controlled on basal insulin (less than 50 U daily)

or liraglutide (less than or equal to 1.8 mg daily). In the US, Xultophy(R)

100/3.6 is not indicated for use as an add-on to oral diabetes medications.4

    About Novo Nordisk

    Novo Nordisk is a global healthcare company with 95 years of innovation and

leadership in diabetes care. This heritage has given us experience and

capabilities that also enable us to help people defeat obesity, haemophilia,

growth disorders and other serious chronic diseases. Headquartered in Denmark,

Novo Nordisk employs approximately 42,700 people in 79 countries and markets

its products in more than 170 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.    Philis-Tsimikas A, Billings LK, Busch R, et al. Superior Efficacy of

Insulin Degludec/Liraglutide (IDegLira) vs Insulin Glargine (IGlar U100) as

Add-on to Sodium-Glucose Co-Transporter-2 Inhibitor (SGLT2i) plus or minus Oral

Antidiabetic Drug (OAD) Therapy in Patients with Type 2 Diabetes (T2D): DUAL IX

Trial (NCT02773368). 78th Annual Scientific Sessions of the American Diabetes

Association (ADA), Orlando, Florida, US; 22-26 June 2018.

    2.    ClinicalTrials.gov. A clinical trial comparing glycaemic control and

safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine

(IGlar) as add-on therapy to SGLT2i in subjects with type 2 diabetes mellitus

(DUAL IX). Available at: https://clinicaltrials.gov/ct2/show/study/NCT02773368.

Last accessed: June 2018.

    3.    EMA. Xultophy(R) Summary of Product Characteristics. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/0026

47/WC500177657.pdf. Last accessed: June 2018.

    4.    Xultophy(R) 100/3.6 [package insert]. Plainsboro, NJ: Novo Nordisk

Inc; November 2016.

     Further information

     Media:

     Katrine Sperling, +45-4442-6718, krsp@novonordisk.com

     Åsa Josefsson, +45-3079-7708, aajf@novonordisk.com

     Michael Bachner (US), +1-609-664-7308, mzyb@novonordisk.com

    Investors:

    Peter Hugreffe Ankersen, +45-3075-9085, phak@novonordisk.com

    Anders Mikkelsen, +45-3079-4461, armk@novonordisk.com

    Christina Kjaer, +45-3079-3009, cnje@novonordisk.com

Source:  Novo Nordisk