New Study Results Show That Patients Have Higher Treatment Satisfaction With
Liraglutide Compared to Exenatide

MONTREAL , Oct. 22 /CNW/ - New data on patient treatment satisfaction from the LEAD(TM) 6 trial presented on the 22nd October at the 20th World Diabetes Congress (International Diabetes Federation) shows that patients have higher overall treatment satisfaction with liraglutide than they do with exenatide.(1)

    
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Specifically, among the 379 patients who completed the Diabetes Treatment Satisfaction Questionnaires (DTSQ) during the LEAD(TM) 6 trial, those taking liraglutide perceived less hypoglycaemia (abnormally low blood sugar levels) or hyperglycaemia (abnormally high blood sugar levels) compared to those on exenatide.(1)

"Liraglutide has shown here in a convincing study that it is associated with less nausea, less perceived hypoglycaemia and definitely higher patient satisfaction compared to exenatide," said Dr Wolfgang Schmidt, professor and chair of the Department of Medicine at St. Josef-Hospital and one of the principal investigators in the trial.

"Patient-reported outcomes data is an important extension of the efficacy data. If a patient is satisfied with his or her treatment, then they are much more likely to really stick to the treatment over the long term, which is necessary in type 2 diabetes," Dr Schmidt noted.

Treatment satisfaction was also evaluated during an open-label extension of the LEAD(TM) 6 trial, in which patients were either switched from exenatide to liraglutide or continued on liraglutide for another 14 weeks. These results show that switching patients from exenatide to liraglutide further improves patient satisfaction, as evidenced by the larger rise in DTSQs scores for switched patients compared to those who continued on liraglutide from weeks 26-40.

Other key liraglutide data at IDF Congress

Two separate meta-analyses of all six LEAD(TM) (Liraglutide Effect and Action in Diabetes) trials were also presented at the congress. Meta-analyses are a type of statistical analysis that summarise the results for a given treatment from several different studies in order to evaluate its overall effect on a specific outcome.

The meta-analyses presented at the congress documented:

1) Liraglutide's positive effect on lipid profile in patients with type 2 diabetes(2) and 2) liraglutide's ability to lower both HbA1C and weight without inducing hypoglycaemia versus that of the other active comparators in the LEAD(TM) programme including exenatide, glimepiride, rosiglitazone and insulin glargine.(3) Each of the meta-analyses comprised 3,967 people with type 2 diabetes.

In the lipid meta-analysis, total cholesterol, low density lipoprotein, free fatty acids and triglycerides were all statistically significantly reduced from baseline with liraglutide over 26 weeks of treatment. Furthermore, total cholesterol and low density lipoproteins were significantly reduced with liraglutide treatment compared to rosiglitazone, glimepiride or insulin glargine.(2)

In the meta-analysis evaluating efficacy on combined treatment targets of HbA1c and weight without hypoglycaemia, more patients in the liraglutide group reached HbA1c(less than)7.0% with no weight gain or hypoglycaemia than those on comparator treatments. Patients were more likely to reach these treatment goals without hypoglycaemia on liraglutide compared to other commonly used diabetes treatments.(3)

LEAD(TM) 6 trial, extension and sub-analysis designs

LEAD(TM) 6 was a 26-week, open-label trial of 464 patients with type 2 diabetes and HbA1c levels between 7-11%, who were randomised to once-daily liraglutide or twice-daily exenatide on a metformin plus or minus sulphonylurea therapy background. Results from this direct comparison trial were published in The Lancet.(4)

In the LEAD(TM) 6 extension trial, patients were either switched from exenatide to liraglutide or continued on liraglutide for a period of 14 weeks. All 389 patients who completed the randomised trial entered into the extension phase.(5)

In the patient-reported outcomes analysis, a subgroup of 379 patients had treatment satisfaction evaluated using two versions of the Diabetes Treatment Satisfaction Questionnaire: status (DTSQs) at baseline and week 26, and change (DTSQc) at week 26. Patients had higher overall treatment satisfaction with liraglutide than they did with exenatide and, in particular, their perception of hyperglycaemia and hypoglycaemia was reduced more by liraglutide than by exenatide.

In the 14-week extension, 313 patients answered the DTSQs at weeks 34 and 40 and the DTSQc at week 34. These results showed that switching patients from exenatide to liraglutide further improves patient satisfaction, as evidenced by the larger rise in treatment satisfaction scores for switched patients compared to those who continued on liraglutide from weeks 26-40.(1)

About Victoza(R)

Victoza(R) is a human glucagon-like peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. Victoza(R) lowers blood glucose by stimulating the release of insulin when blood sugar levels are high and also by slowing gastric emptying. Victoza(R) also reduces body weight and body fat mass through mechanisms involving reduced hunger and lowered energy intake.

The European Commission granted marketing authorisation for Victoza(R) on 30 June 2009 for all 27 European Union member states and it is already on the market in Germany , the UK and Denmark . According to this authorisation, Victoza(R) is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control:

    
    -   in combination with metformin or a sulphonylurea in patients with
        insufficient glycaemic control despite maximal tolerated dose of
        monotherapy with metformin or sulphonylurea, and

    -   in combination with metformin and a sulphonylurea or metformin and a
        thiazolidinedione in patients with insufficient glycaemic control
        despite dual therapy.
    

Multimedia press release:

To view an online version of this press release, including video comments from Dr Wolfgang Schmidt, Professor of Medicine, St Josef Hospital Ruhr-Bochum University, Germany , Dr Bernard Zinman, Director, Leadership Sinai Centre for Diabetes, Professor of Medicine, University of Toronto , Canada and Dr Mads Krogsgaard Thomsen, Chief Science Officer, Novo Nordisk, Copenhagen , please visit, http://multivu.prnewswire.com/mnr/prne/novo/37559/

For more information on Victoza(R), please visit http://www.novonordisk.com/victoza-pressroom

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark , Novo Nordisk employs approximately 28,500 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London . Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit http://www.novonordisk.com.

    
    References

    (1) Christiansen et al. Improved patient-reported outcomes following
        treatment for type 2 diabetes with liraglutide compared with
        exenatide, in addition to metformin, sulphonylurea or both, 20th
        World Diabetes Congress 18-22 Oct 2009, Montreal, CAN; Abstract
        P-1403.

    (2) Plutzky et al. Reductions in lipids and CV risk markers in T2D
        patients treated with liraglutide: a meta-analysis. 20th World
        Diabetes Congress 18-22 Oct 2009, Montreal, CAN; Abstract O-0542.

    (3) Zinman et al. Impact of liraglutide on reaching target HbA1C without
        weight gain or hypoglycaemia, versus other T2D therapies. 20th World
        Diabetes Congress 18-22 Oct 2009, Montreal, CAN; Abstract D-0910.

    (4) Buse J et al. A switch from twice-daily exenatide to once-daily
        liraglutide further improves glycaemic control in patients with type
        2 diabetes on oral patients. Diabetologia 2009; 52 (Suppl. 1):
        Abstract 2.

    (5) Buse J, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett J,
        Zychma M, Blonde L for the LEAD 6 study group. Liraglutide once a day
        versus exenatide twice a day for type 2 diabetes: a 26-week
        randomised, parallel-group, multinational, open-label trial (LEAD-6).
        Lancet 2009; 374 (9683): 39-47.
    

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