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

Bagsværd, Denmark (ots/PRNewswire) -

Oral Presentation #127-OR

Adults with type 2 diabetes treated with Xultophy® (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® (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® study
group versus a 2.0 kg weight gain with insulin glargine U-100.
Treatment with Xultophy® 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® 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® 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 (>=5%) in the Xultophy® treated patients
included viral upper respiratory tract infection, headaches, back
pain, increased lipase and nausea. The safety profile of Xultophy® in
DUAL IX was consistent with previous Xultophy® 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) ± 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® 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®

Xultophy® 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® 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® is called Xultophy® 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® 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) ± 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® Summary of Product Characteristics. Available
at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produ
ct_Information/human/002647/WC500177657.pdf. Last accessed: June
2018.

4. Xultophy® 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 Kjær, +45-3079-3009, cnje@novonordisk.com

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