New Xultophy® (IDegLira) Phase 3b Study Showed Statistically Significant HbA1c Reduction, Body Weight Change and Lower Rate of Hypoglycaemia Versus Insulin Glargine

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- 166-OR

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New phase 3b findings showed adults with type 2 diabetes treated
with Xultophy(R) (IDegLira), a once-daily, single-injection
combination of insulin degludec and liraglutide, demonstrated
statistically significant reduction in HbA1c(average blood glucose
over the previous three months), change in body weight and a lower
rate of hypoglycaemia compared with patients treated with insulin
glargine.[1]

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Findings from the phase 3b DUAL(TM) V 26-week trial that compared
the efficacy and safety of Xultophy(R) versus insulin glargine, both
added on to metformin, in patients with type 2 diabetes uncontrolled
on insulin glargine (20-50 units/day), were presented today at the
75th Annual Scientific Sessions of the American Diabetes Association
(ADA) in Boston, Massachusetts, United States.[1]

At 26 weeks, patients randomised to Xultophy(R) treatment achieved
a statistically significant mean reduction in HbA1c of 1.8% from
baseline (8.4% to 6.6%) compared with a 1.1% reduction (8.2% to 7.1%)
achieved by patients who further increased their dose of insulin
glargine (p<0.001).[1] In the Xultophy(R) group, 72% of patients
achieved an HbA1c of <7% at the end of the trial, compared with 47%
of patients in the insulin glargine group (p?0.001).[1] Furthermore,
39% of patients treated with Xultophy(R) achieved an HbA1c <7%
without hypoglycaemia and weight gain versus 12% treated with insulin
glargine (p<0.001).[1]

"The results demonstrated that IDegLira treatment could positively
impact patients who are not in control on their current basal insulin
therapy," said Professor John Buse, University of North Carolina
School of Medicine, Chapel Hill, North Carolina, US. "IDegLira
patients achieved an end of trial mean HbA1c of 6.6% while still
experiencing weight reduction, and had significantly less
hypoglycaemia than patients taking higher doses of insulin glargine."

There was a 57% lower rate of confirmed hypoglycaemia with
Xultophy(R) compared with insulin glargine (2.23
episodes/patient-year vs 5.05 episodes/patient-year; p<0.001).[1]
Additionally, there was a significant difference of 3.2 kg (7.1 lb)
in change in body weight between treatment groups (p<0.001); body
weight decreased by 1.4 kg (3.0 lb) from baseline for patients
treated with Xultophy(R) and increased by 1.8 kg (4.0 lb) for
patients treated with insulin glargine.[1] Patients treated with
Xultophy(R) required significantly less insulin than patients treated
with insulin glargine, demonstrated by the end-of-trial dose of 41
units of the insulin degludec component in Xultophy(R) versus 66
units respectively (p<0.001).[1]

In the DUAL(TM) V trial, there were similar rates of overall and
serious adverse events in the two treatment groups.[1]

Also presented during the scientific meeting were additional
patient-reported outcomes (PRO) data measured by TRIM-D (Treatment
Related Impact Measure-Diabetes) and SF-36 v2 (Short-Form 36 Health
Survey version 2) from DUAL(TM) V:

- Insulin Degludec/Liraglutide (IDegLira) Improves Patient-Reported Impacts
in Subjects With Type 2 Diabetes (T2D) Inadequately Controlled on Insulin Glargine
(IG) Plus Metformin (Met): DUAL(TM) V Study (Abstract #2550-PO).

About Xultophy(R)

Xultophy(R) is a once-daily single injection combination of
Tresiba(R) (insulin degludec), a once-daily basal insulin analogue
with an ultra-long duration of action and Victoza(R) (liraglutide), a
once-daily human GLP-1 analogue.[2] The maximum dose of Xultophy(R)
is 50 dose steps (equivalent to 50 units of insulin degludec and 1.8
mg of liraglutide). Xultophy(R) is being investigated in the DUAL(TM)
clinical trial programme which includes two phase 3a and a number of
phase 3b trials, encompassing more than 3,500 people with type 2
diabetes. Xultophy(R) was granted marketing authorisation by the
European Commission on 18 September 2014 and approved in Switzerland
on 12 September 2014.[2],[3]

About DUAL(TM) V

DUAL(TM) V was a phase 3b, 26-week, treat-to-target, randomised,
open-label, multicentre trial conducted in 10 countries with 557
patients. The trial was designed to show non-inferiority in HbA1c and
to subsequently demonstrate superiority in HbA1c, body weight and
hypoglycaemia. The trial compared the efficacy and safety of
Xultophy(R) versus insulin glargine, both added on to metformin, in
adults with type 2 diabetes uncontrolled on insulin glargine (20-50
units). The pre-trial mean dose of insulin glargine was 32 units.
Patients could be titrated to the maximum dose of Xultophy(R)
(equivalent to 50 units of insulin degludec and 1.8 mg of
liraglutide) and there was no maximum daily dose of insulin
glargine.[1],[4]

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 39,000 people in 75 countries and markets its products
in more than 180 countries. For more information, visit
novonordisk.com [http://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. Buse J, et al . Insulin Degludec/Liraglutide (IDegLira) is
Superior to Insulin Glargine (IG) in A1c reduction, Risk of
Hypoglycaemia and Weight Change: DUAL V Study. Oral presentation
(#166-OR) at the 75th Scientific Sessions of the American Diabetes
Association (ADA), 7 June 2015.

2. EMA. Xultophy(R) Summary of Product Characteristics. Available
at: http://ec.europa.eu/health/documents/community-register/2014/2014
0918129550/anx_129550_en.pdf Last accessed: 03.02.2015.

3. SwissMedic. Xultophy(R): Information for Professionals.
22.09.2014.

4. ClinicalTrials.gov. NCT01952145. A Trial Comparing the Efficacy
and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in
Subjects With Type 2 Diabetes Mellitus (DUAL(TM) V). Available at: ht
tps://www.clinicaltrials.gov/ct2/show/study/NCT01952145?show_locs=Y#l
ocn Last accessed: 03.02.2015.

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+45-3079-4303,
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