Victoza(R) (liraglutide 1.8 mg) Provided Superior HbA1c Reductions in Adults with Type 2 Diabetes Compared to Continued Sitagliptin Treatment

PR63973

BOSTON, Apr. 3 /PRNewswire=KYODO JBN/ --

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    Abstract #689-P

    Findings from a clinical trial comparing Victoza(R) (liraglutide 1.8 mg)

and sitagliptin (100 mg), both in combination with metformin, demonstrated that

switching from sitagliptin to Victoza(R) provided superior HbA1c reductions vs

continuing with sitagliptin treatment in adults with type 2 diabetes. Results

from the LIRA-SWITCH trial were presented at the Endocrine Society's 98th

Annual Meeting and Expo (ENDO 2016) in Boston, MA, US.[1]

    The 26-week LIRA-SWITCH trial assessed the efficacy and safety of

Victoza(R) as an add-on to metformin in 407 adults with type 2 diabetes who

switched from sitagliptin.[1] Of the 407 adults uncontrolled on sitagliptin

(HbA1c 7.5-9.5%) at week 26, those who switched to Victoza(R) (n=203) achieved

a superior reduction in HbA1c vs those who continued their sitagliptin

treatment (n=204) (-1.14% vs -0.54%; estimated treatment difference [ETD]

-0.61%, 95% confidence interval [CI]: -0.82 to -0.40, p less than 0.0001).[1]

    Additionally, adults who switched to Victoza(R) experienced significantly

greater body weight reductions vs those who continued with their sitagliptin

dose (-3.31 kg/-7.29 lb vs -1.64 kg/-3.62 lb; ETD -1.67 kg/-3.68 lb, 95% CI:

-2.34 to -0.99, p less than 0.0001).[1]

    "The LIRA-SWITCH trial results provide valuable insight that adults

uncontrolled on sitagliptin may achieve a superior HbA1c reduction with

liraglutide 1.8 mg vs continuing on sitagliptin treatment," said Dr Maximo

Maislos, Director of Western Negev Mobile Diabetes Clinic Program, and Diabetes

and Metabolism, Ben-Gurion University FOHS, Beer Sheva-Israel and investigator

of the LIRA-SWITCH trial. "These findings are valuable as there is limited

clinical evidence to guide treatment strategy when people with type 2 diabetes

are uncontrolled on second-line therapy."

    The trial demonstrated that more adults with type 2 diabetes treated with

Victoza(R) vs sitagliptin achieved HbA1c targets less than 7% (50.6% vs 26.9%;

OR [odds ratio]: 3.36; 95% CI: 2.08 to 5.42, p less than 0.0001) and less than

or equal to 6.5% (29.5% vs 9.9%; OR: 5.44; 95% CI: 2.82 to 10.47, p less than

0.0001).[1] Furthermore, adults treated with Victoza(R) demonstrated

significantly greater reductions in fasting plasma glucose vs those treated

with sitagliptin (-1.84 vs -0.73; ETD: -1.10; 95% CI -1.50 to -0.71, p less

than 0.0001).[1],[2]

    Adverse events were more common in the Victoza(R) group vs the sitagliptin

group (68.8% vs 56.9%), with gastrointestinal side effects more frequent with

Victoza(R): nausea (21.8% vs 7.8%) and diarrhoea (16.3% vs 9.3%).[1] There were

no reports of severe hypoglycaemia and no reports of confirmed nocturnal

hypoglycaemia.[1]

    About the LIRA-SWITCH Trial

    The 26-week trial was a randomised, double-blind, double-dummy,

active-controlled trial involving 407 adults with type 2 diabetes not achieving

adequate glycaemic control on sitagliptin as add-on to metformin.[1] Trial

participants were previously treated with stable doses of sitagliptin (100 mg

daily) and metformin (greater than or equal to1500 mg daily or maximum

tolerated dose greater than or equal to1000 mg daily) for greater than or equal

to90 days.[1] Participants were randomised 1:1 to switch to Victoza(R) 1.8 mg

or continue sitagliptin 100 mg, both in combination with metformin.[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.*[3] In addition,

liraglutide reduces body weight and body fat mass through mechanisms involving

reduced appetite and lowered energy intake.[3]

    Victoza(R) was launched in the EU in 2009 and is commercially available in

more than 80 countries, treating more than 1 million people with type 2

diabetes globally.[3],[4] In Europe, Victoza(R) is indicated for the 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.[3]

In the US, Victoza(R) was approved in 2010 as an adjunct to diet and exercise

to improve blood glucose control in adults with type 2 diabetes.[5]

    *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 41,000 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 ]

    Further information  

    Media:

    Katrine Sperling

    +45-4442-6718

    krsp@novonordisk.com;

    Asa Josefsson

    +45-3079-7708

    aajf@novonordisk.com

    Investors:

    Peter Hugreffe Ankersen

    +45-3075-9085

    phak@novonordisk.com;

    Daniel Bohsen

    +45-3079-6376

    dabo@novonordisk.com;

    Melanie Raouzeos

    +45-3075-3479

    mrz@novonordisk.com;

    Kasper Veje

    +45-3079-8519

    kpvj@novonordisk.com

    References

    1) Bailey T, Takacs R, Tinahones F, et al. Efficacy and safety of switching

from sitagliptin to liraglutide in subjects with type 2 diabetes: a randomized,

double-blind, double-dummy, active-controlled 26-week trial. Abstract number

689-P. Endocrine Society's 98th Annual Meeting and Expo (ENDO 2016), Boston,

MA, US; 1-4 April 2016.

    2) Data on file. Novo Nordisk. NCT01907854.

    3) EMA. Victoza(R) EU Summary of Product Characteristics. November 2015.

Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001026/WC500050017.pdf

Lastaccessed 29.03.2016.

    4) Internal Calculations based on IMS Midas Quantum data. September 2015.

    5) FDA. Victoza(R) US prescribing information. Available at:       

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf.

Last accessed 29.03.2016.

   SOURCE: Novo Nordisk