Data show patients with type 2 diabetes are likelier to reach HbA1c target <7% during 26 weeks' treatment with Victoza® (liraglutide) compared with sitagliptin or exenatide BID (27 November 2012)

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Kyoto, Japan, 27 November 2012 - New data analyses show that more patients with type 2 diabetes achieve target HbA1c levels of less than 7.0% for the first time with liraglutide at any given time point during 26 weeks of treatment (12, 20 and 26 weeks) than with sitagliptin or exenatide BID. A Cox proportional hazards model indicates that patients with type 2 diabetes treated with:

·         liraglutide 1.2 mg had a significant higher estimated chance of reaching the target of HbA1c<7.0% (1.76 times more likely, 95% CI 1.32; 2.34) across the 26-week treatment period than those treated with sitagliptin (p<0.0030) 1.

·         Liraglutide 1.8 mg was estimated to be 2.1 times (95% CI 1.62; 2.82) more likely to reach the target of HbA1c<7.0% across the 26-week treatment period than those treated with sitagliptin (p<0.0001) 1.

·         liraglutide 1.8 mg had a significantly higher estimated chance of reaching the target of HbA1c<7.0% (1.5 times more likely, 95% CI 1.17; 1.92) across the 26-week treatment period than those treated with exenatide BID (p<0.0068)1.

These data were presented today at the 9th Annual International Diabetes Federation Western Pacific Region congress in Kyoto, Japan.

Another analysis2, presented today, demonstrated that in type 2 diabetes patients treated with add-on to only metformin with a baseline of HbA1c<8%, liraglutide 1.8 mg brings significantly more patients to HbA1c target of <7% compared to exenatide BID (84% vs 61.5%, p=0.03) and sitagliptin (77.6% vs 36.7%, p<0.0001) over a 26-week period. Improving blood sugar control, even in patients who are close to their blood sugar target, can help to reduce the risk of complications associated with diabetes3,4.

"These results show the benefit of liraglutide in helping physicians to manage their patients' blood glucose levels" said Dr Allen King from the Diabetes Care Centre, Salinas, California. "In patients who are slightly above goal, liraglutide is more likely to achieve target HbA1c <7% compared to sitagliptin and exenatide BID. We know that by achieving treatment goals sooner, outcomes are improved so it's important that effective treatments, such as liraglutide, are used early in the management of type 2 diabetes."

Key findings from the studies include:

Patients likelier to reach HbA1c target during 26 weeks' treatment with liraglutide compared with sitagliptin or exenatide BID (Poster 00490)1

·           A post-hoc analysis of two Phase 3b studies, involving patients with type 2 diabetes,  looked at how many patients reached the study target of HbA1c<7.0% for the first time at 12, 20 and 26 weeks of treatment. 

·           In both studies, greater proportions of patients reached the study target for the first time at each time point with liraglutide (once daily, compared to sitagliptin (100 mg once daily) or exenatide BID (10 µg twice daily).

·          In the liraglutide (n=439) vs sitagliptin (n=219) study the likelihood of achieving target of HbA1c<7.0% during the trial was significantly higher for liraglutide 1.2 mg or 1.8 mg compared to sitagliptin (after 26 weeks' treatment liraglutide 1.2 mg HR 1.76 [1.32; 2.34], p<0.0030; liraglutide 1.8 mg HR 2.13 [1.62; 2.82], p<0.0001).

·          In the LEAD-6 study the likelihood of achieving target of HbA1c<7.0% during the trial was significantly higher with liraglutide 1.8 mg (n=233) compared to exenatide BID (n=231) (after 26 weeks' treatment HR 1.50 [95% CI: 1.17; 1.92], p<0.0068).

 

In type 2 diabetes patients with baseline HbA1c<8.0%, liraglutide achieves HbA1c targets more often than sitagliptin or exenatide BID (Poster 00441)2

·           A post-hoc analysis of the LEAD-6 and liraglutide vs sitagliptin studies investigated efficacy of liraglutide 1.8 mg (once daily) compared to exenatide BID (10 µg twice daily) and sitagliptin (100 mg once daily), after 26 weeks' treatment. Only patients treated with add-on to only metformin, and with baseline HbA1c< 8.0%, were included.

·           In these analyses, liraglutide treatment resulted in a significantly higher proportion of patients reaching a target of HbA1c<7.0% compared to exenatide BID and sitagliptin. 

·          In the liraglutide vs sitagliptin study liraglutide 1.8 mg (n=72) demonstrated a significantly greater reduction in HbA1c and a higher proportion of patients reached targets of <7.0% compared to sitagliptin (n=61) (after 26 weeks' treatment odds ratio 6.0 [2.7; 13.1] p<0.0001). Few patients experienced minor hypoglycaemia with liraglutide or sitagliptin (8.3% vs. 8.2%).

·          In the LEAD-6 study, treatment with liraglutide 1.8 mg (n=44) resulted in a non-significant greater reduction in HbA1c compared to exenatide BID (n=41). Significantly more patients achieved a target of <7.0% HbA1c with liraglutide 1.8 mg compared to exenatide BID (at 26 weeks' treatment odds ratio 3.3 [1.2; 9.5] p<0.05). The proportion of patients experiencing minor hypoglycaemia was similarly low with liraglutide and exenatide BID (9.1% vs. 9.8%).

·           Estimated treatment differences in body weight from baseline showed that liraglutide 1.8 mg demonstrated significant greater weight loss compared to sitagliptin (-2.96 kg [p<0.0001]) and greater weight loss compared to exenatide BID (-1.06 kg [did not reach statistical significance]).

 

About Victoza®

Victoza® 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[1]. The mechanism of blood sugar lowering also involves a delay in gastric emptying.5

Victoza® was approved on 30 June 2009 by the European Commission in all 27 European Union member states. In Europe, Victoza® is indicated for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control, in combination with metformin and or sulphonylurea or metformin and thiazolidinedione.5 On 25 January 2010, Victoza® was approved in the US as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes. Victoza® has been commercially launched in more than 50 countries globally. Since its launch in 2009, Victoza® has been prescribed to more than half a million patients.6

 

About Cox proportional hazards model

Clinical trials commonly record the length of time from study entry to achieve a specific outcome for a treatment and a control group. The analyses presented in this press release looked at the duration of treatment to reach HbA1c<7% for the first time, over a study period of 26 weeks.

In this study, investigators used a statistical model, known as a Cox proportional hazards model with treatment and previous OAD treatment as fixed effects; baseline HbA1c as covariate, to estimate the differences between liraglutide and sitagliptin or exenatide BID over the 26-week period. These estimates are represented as hazard ratios which estimate the chance of reaching HbA1c<7% across the 26-week treatment period with liraglutide compared with exenatide BID or sitagliptin. In the analysis of the LEAD-6 study, the estimated hazard ratio was 1.50 (95% CI: 1.17; 1.92). This indicates that patients treated with Victoza® 1.8 mg had a significantly higher estimated chance of reaching HbA1c<7% (1.5 times more likely) across the 26-week treatment period than those treated with exenatide BID (p<0.0068).

In the analysis of the liraglutide vs sitagliptin study the estimated hazard ratio was 1.76 (95% CI: 1.32; 2.34). This indicates that patients treated with Victoza® 1.2 mg had a significantly higher estimated chance of reaching HbA1c<7% (1.76 times more likely) across the 26-week treatment period than those treated with sitagliptin (p<0.0030).

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk.com.

   

Further information

Media:

   

Katrine Sperling

+45 4442 6718

krsp@novonordisk.com

Ambre Morley (US)

+1 609 216 5240 

abmo@novonordisk.com

     

Investors:

   

Kasper Roseeuw Poulsen

+45 4442 4303

krop@novonordisk.com

Frank Daniel Mersebach

+45 4442 0604

fdni@novonordisk.com

Lars Borup Jacobsen

+45 3075 3479

lbpj@novonordisk.com

Jannick Lindegaard (US)

+1 609 786 4575

jlis@novonordisk.com

References

[1] Donsmark et al. Patients Likelier to Reach A1c Target during 26 Weeks' Treatment with Liraglutide Compared with Sitagliptin or Exenatide, presented at the 9th annual International Diabetes Federation Western Pacific Region congress 2012.

[2] King et al. In T2D Patients with Baseline A1c<8.0%, Liraglutide Achieves A1c Targets More Often than Sitagliptin or Exenatide, presented at the 9th annual International Diabetes Federation Western Pacific Region congress 2012.

[3] Standards of Medical Care in Diabetes - 2012. Diabetes Care 2012;35:S11-S63

[4] Stratton et al. Association of glycaemia with microvascular and macrovascular complications of type 2 diabetes (UKPDS 35): prospective observational stud. BMJ 2000;321:405-412.

[5] Victoza® Summary of Product Characteristics (2012). Available at URL: http://www.medicines.org.uk/EMC/medicine/21986/SPC/Victoza+6+mg+ml+solution+for+injection+in+pre-filled+pen. Last accessed: September 2012.

[6] Internal Calculations based on IMS Midas Quantum data, May 2012


[1] Hypoglycaemia has primarily been observed when Victoza® is combined with a sulphonylurea.