Two-year data show investigational drug liraglutide more effective at lowering blood sugar than glimepiride

    NEW ORLEANS, June 8 /CNW/ - Data presented today at the 69th Annual
Scientific Sessions of the American Diabetes Association (ADA) showed that
once-daily liraglutide, taken as monotherapy, leads to statistically
significant and sustained reductions in blood sugar and weight after two years
of treatment.
    In the study, 58% of patients treated with liraglutide 1.8 mg once daily,
and 53% of patients treated with liraglutide 1.2 mg once daily reached and
maintained the ADA's blood sugar target of HbA(1C) less than 7% versus 37% of
patients treated with glimepiride 8 mg once daily.(1)
    "The fact that liraglutide continues to effectively lower blood sugar
after two years of treatment is consistent with its other long-term clinical
benefits such as continued reductions in fasting blood sugar and weight,"
said, Dr Alan Garber, Baylor College of Medicine, Houston, a LEAD(TM) 3
principal study investigator. "Even with available treatments, many type 2
diabetes patients still struggle to control their blood sugar, while losing
weight. Liraglutide represents an important advance for these patients."
    The LEAD(TM) 3 extension study also documented that treatment with
liraglutide leads to early and lasting weight loss. Many currently available
diabetes treatments lead to weight gain,(2) a concern for type 2 diabetes
patients, most of whom are already overweight.(3) After two years of treatment
with 1.8 mg or 1.2 mg of liraglutide, mean body weight decreased significantly
(-2.7 kg and -2.1 kg) compared to overall weight increase in the glimepiride
group (+1.1 kg).
    Hypoglycaemia is a condition where blood sugar levels become too low.
Minor hypoglycaemia was six times less frequent in the liraglutide treatment
groups compared with the glimepiride group.(1)

    About LEAD(TM) 3 extension

    The LEAD(TM) 3 extension compared the efficacy and safety of liraglutide
(1.8 mg and 1.2 mg, once daily) to glimepiride (8 mg, once daily) in patients
with type 2 diabetes. Patients were treated previously with diet/exercise or
low doses of one oral antidiabetic drug (OAD). The trial had a 52-week
randomised, double-blind period followed by the one-year extension; 59%
entered the extension period of the trial and 43% of these patients completed
the full two-year study period.

    LEAD(TM) 3: two-year data

    Two years'                    Liraglutide    Liraglutide     Glimepiride
    monotherapy                    1.8 mg, QD     1.2 mg, QD      8 mg, QD
                                  N equals 154   N equals 149   N equals 137
    Diabetes duration,
    years at baseline             5.0            5.0            5.0
    % diet/exercise               35%            38%            34%
    % OAD                         65%            62%            66%
    HbA(1C) % at
    baseline                      8.1            8.1            8.0
    BMI, kg/m(2) at
    baseline                      33             33             33
    Change in HbA(1C)%
    from baseline                 -1.1           -0.9           -0.6
    Change in HbA(1C)%
    from baseline (in patients    -1.4           -1.1           -0.7
    with less than 3 years'
    duration of diabetes)
    HbA(1C)% less than 7.0%       58             53             37
    Change FPG
    (Fasting Plasma
    Glucose) mg/dL                -27 (-1.5)     -24 (-1.3)     -6 (-0.3)
    (mmol/L) from baseline
    Weight change, kg
    from baseline                 -2.7           -2.1           1.1
    Minor hypoglycaemic
    events/patient/year           0.23           0.21           1.76

    Safety and tolerability of liraglutide

    The rate of minor hypoglycaemia was statistically significantly lower
with both liraglutide dose groups compared to the glimepiride-treated group.
The most common gastrointestinal-related adverse events were nausea, diarrhoea
and vomiting, and most were transient.(4)

    About LEAD(TM) (Liraglutide Effect and Action in Diabetes)

    The LEAD(TM) programme comprises five randomised, controlled,
double-blinded studies plus one open-label head-to-head study against
exenatide and involved more than 4,000 patients with type 2 diabetes in 40

    About liraglutide

    Once-daily liraglutide is the first human Glucagon-Like Peptide-1 (GLP-1)
analogue developed for the treatment of type 2 diabetes. Liraglutide works by
stimulating the release of insulin only when blood sugar levels are high.
Weight loss with liraglutide is attributed to the fact that it slows gastric
emptying and leads to increased satiety after meals. Liraglutide is naturally
broken down in the body and does not require renal excretion.
    On 23 May 2008, Novo Nordisk submitted a New Drug Application to the Food
and Drug Administration (FDA) in the US, as well as a marketing authorisation
application to the European Medicines Agency (EMEA), for the approval of
liraglutide for the treatment of people with type 2 diabetes. A New Drug
Application was also submitted for approval in Japan on 14 July 2008.
    On 23 April 2009, Novo Nordisk announced that the Committee for Medicinal
Products for Human Use (CHMP) under the EMEA adopted a positive opinion,
recommending marketing authorisation of liraglutide for treatment of type 2
diabetes in Europe.
    In the US, a regulatory decision from FDA is pending.
    For more information, please visit - Media - Liraglutide
press room.

    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 27,900 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


    (1) Garber A, Henry R, Ratner R et al. Monotherapy with Liraglutide, a
        Once-Daily Human GLP-1 Analog, Provides Sustained Reductions in
        HBHBA1C, FPG, and Weight Compared with Glimepiride in Type 2
        Diabetes: LEAD-3 mono 2- year Results. 2009. Presented at the
        American Diabetes Association annual congress, 6 June 2009, New
        Orleans, USA.

    (2) Krentz AJ. Management of type 2 diabetes in the obese patient:
        current concerns and emerging therapies. 2008: 401-417.

    (3) Triplitt C, McGill JB, Porte D, Jr. et al. The changing landscape of
        type 2 diabetes: the role of incretin-based therapies in managed care
        outcomes. J Manag Care Pharm 2007; 13(9 Suppl C):S2-16.

    (4) Garber A, Henry R, Ratner R et al. Liraglutide versus glimepiride
        monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week,
        phase III, double-blind, parallel-treatment trial. Lancet 2009; 373

For further information:

For further information: Media: Elin K. Hansen, Tel: (+45) 4442 3450,; In Canada: Marsha Knoll, Edelman, (416) 979-1120 x. 329,; Investors: Mads Veggerby Lausten, Tel: (+45) 4443
7919,; Kasper Roseeuw Poulsen, Tel: (+45) 4442 4471,; Hans Rommer, Tel: (+1) 609 919 7937,

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