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

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Abstract #689-P

Findings from a clinical trial comparing Victoza® (liraglutide 1.8
mg) and sitagliptin (100 mg), both in combination with metformin,
demonstrated that switching from sitagliptin to Victoza® 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® 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® (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<0.0001).[1]

Additionally, adults who switched to Victoza® 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<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® vs sitagliptin achieved HbA1c targets <7%
(50.6% vs 26.9%; OR [odds ratio]: 3.36; 95% CI: 2.08 to 5.42,
p<0.0001) and <=6.5% (29.5% vs 9.9%; OR: 5.44; 95% CI: 2.82 to 10.47,
p<0.0001).[1] Furthermore, adults treated with Victoza® 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<0.0001).[1],[2]

Adverse events were more common in the Victoza® group vs the
sitagliptin group (68.8% vs 56.9%), with gastrointestinal side
effects more frequent with Victoza®: 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 (>=1500 mg daily or
maximum tolerated dose >=1000 mg daily) for >=90 days.[1]
Participants were randomised 1:1 to switch to Victoza® 1.8 mg or
continue sitagliptin 100 mg, both in combination with metformin.[1]

About Victoza®

Victoza® (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® 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® 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® 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® 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® 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® 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

Åsa 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, Takács 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® EU Summary of Product Characteristics. November
2015. Available at: http://www.ema.europa.eu/docs/en_GB/document_l
ibrary/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® US prescribing information. Available at: http://www
.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf.
Last accessed 29.03.2016.

ots Originaltext: Novo Nordisk A/S
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