Victoza® (liraglutide) Provides Significantly Greater HbA1c Reduction than Lixisenatide in New Clinical Trial

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Abstract #75

Findings from a head-to-head trial comparing Victoza(R) (liraglutide)
and lixisenatide, both in combination with metformin, demonstrated a
significantly greater reduction in HbA1c of -1.83% for liraglutide vs
-1.21% for lixisenatide in adults with type 2 diabetes.[1]Results
from the LIRA-LIXI trial were announced today in an oral presentation
at the 51st Annual Meeting of the European Association for the Study
of Diabetes (EASD) in Stockholm, Sweden.

The 26-week LIRA-LIXI trial compared the efficacy and safety of
Victoza(R) versus lixisenatide, both as add-on to metformin in 404
people with type 2 diabetes.[1] People with type 2 diabetes treated
with Victoza(R) achieved a significantly greater reduction in HbA1c
versus lixisenatide at 26 weeks, meeting the trial's primary endpoint
(-1.83% vs -1.21%; estimated treatment difference [ETD] -0.62%
[-0.80;  -0.44]; P<0.0001).[1] In addition, more people treated
with Victoza(R) achieved HbA1c targets of <7% (74.2% vs 45.5%;
odds ratio (OR) 4.16; [2.58; 6.73]; P<0.0001)[1] and less than or
equal to6.5% (54.6% vs 26.2%; OR 3.66; [2.31; 5.81]; P<0.0001)
compared with lixisenatide.[1]

"The significant difference in blood glucose control between
liraglutide and lixisenatide reported in the LIRA-LIXI trial
reinforces the value of liraglutide as an efficacious treatment for
those with type 2 diabetes otherwise treated with oral
glucose-lowering drugs," said Professor Michael A Nauck, director and
diabetologist, Division of Diabetology, St. Josef Hospital,
Ruhr-University Bochum, Germany and principal investigator of the
LIRA-LIXI trial. "Many people living with type 2 diabetes remain
uncontrolled and it is crucial for these patients to gain control of
their blood glucose levels to help prevent further complications from
this disease."

Furthermore, Victoza(R) demonstrated significantly greater reductions
in fasting plasma glucose (-2.85 mmol/L vs -1.70 mmol/L; ETD -1.15
mmol/L [95% CI -1.51; -0.80] ; P<0.0001) and mean 9-point
self-measured plasma glucose (-2.64 mmol/L vs. -1.89 mmol/L; ETD
-0.75 mmol/L [95% CI -1.08;  -0.42]; P<0.0001) compared with
lixisenatide.[1] Lixisenatide, however, had smaller postprandial
increments for the meal following injection compared to Victoza(R)
(morning meal: -2.12 mmol/L vs -0.88 mmol/L; ETD 1.24 mmol/L; [0.69;
1.79]; P<0.0001; and evening meal: -1.88 mmol/L vs -0.53 mmol/L;
ETD 1.36 mmol/L; [0.44; 2.27];P=0.0039).[1]

Weight loss was observed in both treatment groups (Victoza(R): -4.26
kg vs lixisenatide: -3.67 kg; ETD -0.59 kg [-1.55; 0.38];
P=0.2347).[1] Systolic and diastolic blood pressure decreased with
both Victoza(R) and lixisenatide treatment (systolic blood pressure:
-4.70 mmHg vs -3.49 mmHg; ETD -1.21 mmHg [-3.87; 1.45]; P=0.3722;
diastolic blood pressure: -2.62 mmHg vs  -2.69 mmHg; ETD 0.07 mmHg
[-1.53; 1.67];P=0.9318, respectively).[1]

The safety profile in the LIRA-LIXI trial was similar between the two
treatment groups. The most common adverse events were
gastrointestinal, which included nausea and diarrhoea. No severe
hypoglycaemic episodes were reported.[1]

About the LIRA-LIXI Trial      

The trial was a 26-week, parallel group, open-label trial involving
404 adults with type 2 diabetes randomised 1:1.[1] The trial
participants were randomised to Victoza(R)  1.8 mg or lixisenatide 20
microg, both as add-on to metformin (at maximum tolerated dose,
1000-3000 mg daily).[1] Dose escalation and administration of
Victoza(R) and lixisenatide were according to the approved label for
both drugs at the time of the trial.[1] Victoza(R)  was administered
once-daily at any time of the day irrespective of meals. Lixisenatide
was administered once-daily within an hour prior to the morning or
evening meal.[1]

About Victoza(R) 

Victoza(R) (liraglutide) is a human glucagon-like peptide-1 (GLP-1)
analogue with an amino acid sequence 97% similar to endogenous human
GLP-1. Like natural GLP-1, Victoza(R)  works by stimulating the
beta-cells to release insulin and suppressing glucagon secretion from
the alpha cells only when blood sugar levels are high. Due to this
glucose-dependent mechanism of action, Victoza(R) is associated with
a low rate of hypoglycaemia.[*],[2] In addition, Victoza(R) reduces
body weight and body fat mass through mechanisms involving reduced
appetite and lowered energy intake.[2]

Victoza(R) was launched in the EU in 2009 and is commercially
available in more than 80 countries with more than 3 million patient
years of use in people with type 2 diabetes globally.[2],[3] In
Europe, Victoza(R) is indicated for treatment of adults with type 2
diabetes to achieve glycaemic control in combination with oral
glucose-lowering medicinal products and/or basal insulin when these,
together with diet and exercise, do not provide adequate glycaemic
control.[2]

[*]Hypoglycaemia has primarily been observed when Victoza(R) is
combined with a sulfonylurea or basal insulin.

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 39,700 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. Nauck M, Rizzo M, Pirags V, et al. Once-daily liraglutide vs.
lixisenatide as add-on to metformin in type 2 diabetes: a 26-week
randomised controlled clinical trial. Oral presentation. Abstract
number 75. 51st Annual Meeting of the European Association of
Diabetes (EASD). 2015

2. EMA. Victoza(R) EU Summary of Product Characteristics. Available a
t: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Product
_Information/human/001026/WC500050017.pdf   Last accessed 17.06.2015.

3. Internal Calculations based on IMS Midas Quantum data. April 2015.

Further information     


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


Asa Josefsson 
+45-30797708 
aajf@novonordisk.com


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


Melanie Raouzeos 
+45-3075-3479 
mrz@novonordisk.com


Daniel Bohsen 
+45-3079-6376 
dabo@novonordisk.com


Frank Daniel Mersebach (US) 
+1-609-235-8567 
fdni@novonordisk.com 

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