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

PR61769

STOCKHOLM, Sweden, Sept. 16, 2015 /PRNewswire=KYODO JBN/ --

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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

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    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 at:

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

SOURCE: Novo Nordisk