Novo Nordisk A/S

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. 

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