New Study With Victoza(R) (Liraglutide) Showed Improvements in Blood Glucose Control in Adults With Type 2 Diabetes Who Fasted During Ramadan

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BOSTON, Massachusetts, June 7, 2015 /PRN=KYODO JBN/ --

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    Abstract #1121-P

    New findings showed that adults with type 2 diabetes treated with

Victoza(R), in combination with metformin, experienced similar improvements in

blood glucose control while fasting during Ramadan (four weeks) compared with

sulfonylurea (SU) plus metformin.[1] People treated with Victoza(R) also

demonstrated significantly better weight loss and fewer confirmed hypoglycaemic

episodes compared with those treated with sulfonylurea during Ramadan.[1]

Findings from the LIRA-Ramadan(TM) study were presented today at the 75th

Annual Scientific Sessions of the American Diabetes Association (ADA) in

Boston, MA.

    The 33-week, open-label, randomised study showed that Victoza(R) sustained

blood glucose control during four weeks of Ramadan, with similar reductions in

fructosamine levels compared with sulfonylurea (-12.8 micromol/L vs. -16.4

micromol/L; estimated treatment difference [ETD] 3.51 micromol/L [-5.26;12.28];

P=0.43).[1] Testing fructosamine allows the effectiveness of diabetes treatment

to be reliably evaluated after a couple of weeks.[2],[3] During Ramadan,

patients treated with Victoza(R) experienced fewer confirmed hypoglycaemic

episodes compared with people treated with sulfonylurea (2.0% vs. 4.3%), even

though the Victoza(R) group had lower fructosamine concentration at the start

of Ramadan. In addition, greater weight loss was observed in people treated

with Victoza(R) during Ramadan vs. sulfonylurea (-1.43 kg/ -3.1 lbs vs. -0.89

kg/ -2.0 lbs; ETD -0.54 kg/ -1.2 lbs [-0.94/ -2.07; -0.14/ -0.31]; P=0.0091).[1]

    "Fasting during Ramadan presents unique medical challenges for people

living with type 2 diabetes and their healthcare providers," said Dr Sami Azar,

Professor of Medicine at the American University of Beirut Medical Center,

Beirut, Lebanon and principal investigator of the LIRA-Ramadan(TM) trial.

"Prolonged fasting, often followed by large nighttime meals, can affect blood

glucose levels and result in severe hypoglycaemia and hyperglycaemia. To help

minimise these risks, physicians and people with type 2 diabetes should

consider evaluating and discussing diabetes management plans in advance of

Ramadan."

    More than 50 million Muslims worldwide with diabetes fast during

Ramadan,[4] the majority of which have been estimated to have type 2

diabetes.[5] Muslims with type 2 diabetes who fast have an estimated 7.5-fold

increased risk of severe hypoglycaemia and a five-fold increased risk of severe

hyperglycaemia (requiring hospitalisation) during Ramadan,[5] which takes place

18 June - 17 July this year.

    In the LIRA-Ramadan(TM) study, people treated with Victoza(R) from baseline

to the end of Ramadan were more likely to achieve an HbA1c target of ＜7% with

no confirmed hypoglycaemic episodes compared with sulfonylurea (53.9% vs.

23.5%; OR 3.80 [2.24;6.46]; P＜0.0001). Also, people treated with Victoza(R)

compared with sulfonylurea experienced significantly greater weight loss (-5.40

kg/ -11.9 lbs vs. -1.46 kg/ -3.2 lbs; ETD -3.94 kg/ -8.7 lbs [-4.54/ -10.0;

-3.33/ -7.3];P＜0.0001), had significantly greater improvements in HbA1c (-1.24%

vs. -0.65%; ETD -0.59% [-0.79; -0.38]; P＜0.0001), were more likely to achieve

the target level of HbA1c ＜7% (57.1% vs. 26.4%; OR 3.71 [2.18; 6.30];

P＜0.0001), and experienced significant reductions in fructosamine levels (-39.6

micromol/L vs. -29.3 micromol/L; ETD -10.3 micromol/L [-18.7; -1.89]; P=0.0165).

    The percentage of patients experiencing adverse events (AEs) during Ramadan

was similar in the Victoza(R) and sulfonylurea groups (23.7% vs. 20.9%), with

gastrointestinal side effects more common with Victoza(R) treatment (10.5% vs.

3.7%). Overall, a low incidence of severe AEs was observed (Victoza(R), 1.3%

vs. sulfonylurea,0%).[1]

    The most common AEs seen during the entire study period were

gastrointestinal (Victoza(R), 56.7% vs. sulfonylurea, 9.4%), and these included

nausea, diarrhoea, vomiting, abdominal pain and abdominal distension.[1]

    About the Study

    The study was a 33-week, open-label, multinational clinical trial involving

343 people (172 for Victoza(R), 171 for sulfonylurea). The study included

people with type 2 diabetes with intent to fast during Ramadan, HbA1c 7-10%,

BMI greater than or equal to20 kg/m2, and treated with a stable dose of

metformin and sulfonylurea (at maximum tolerated dose). Study participants were

randomised to either switch to Victoza(R) (1.8 mg) or continue pre-trial

sulfonylurea, both in combination with pre-trial metformin. Victoza(R) doses

were escalated over 3 weeks, and followed by a 6- to 19-week treatment

maintenance period preceding Ramadan. The primary endpoint was change in

fructosamine from start to end of Ramadan (4-week period). Secondary endpoints

included number of confirmed hypoglycaemic episodes during Ramadan as well as

HbA1c reduction, HbA1c target ＜7% with no hypoglycaemic episodes and weight

change at end of Ramadan from baseline.

    About Victoza(R)

    Victoza(R) (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(R) 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(R) is associated with a low rate of hypoglycaemia.[*],[6] In addition,

Victoza(R) reduces body weight and body fat mass through mechanisms involving

reduced appetite and lowered energy intake.

    Victoza(R) was launched in the EU in 2009 and is commercially available in

more than 75 countries with more than 2.9 million patient years of use in

people with type 2 diabetes globally.[6],[7] In Europe, Victoza(R) is indicated

for 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.[6] In the US, Victoza(R) was approved on 25 January 2010 as an adjunct

to diet and exercise to improve blood glucose control in adults with type 2

diabetes.[8]

    [*]Hypoglycaemia has primarily been observed when Victoza(R) is combined

with a sulfonylurea or a 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 39,000 people in

75 countries, and markets its products in more than 180 countries. For more

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    References

    1. Azar S, Echtay A, Mohamad W, et al. Efficacy and safety of liraglutide

versus sulfonylurea both in combination with metformin during Ramadan in

subjects with type 2 diabetes (LIRA-Ramadan): A randomized trial. Poster

presented at 75th Scientific Sessions of the American Diabetes Association

(ADA). June 2015.

    2. Malmstrom H, Walldius G, Grill V, et al. Fructosamine is a useful

indicator of hyperglycaemia and glucose control in clinical and epidemiological

studies--cross-sectional and longitudinal experience from the AMORIS cohort.

PLoS One. 2014; 9:e111463.

    3. Lab Tests Online. Fructosamine testing. Available at:

http://labtestsonline.org.uk/understanding/analytes/fructosamine/tab/test

Accessed on: 23/05/2015.

    4. Al-Arouj M, Assaad-Khalil S, Buse J, et al. Recommendations for

management of diabetes during Ramadan: update 2010. Diabetes Care. 2010;

33:1895-1902.

    5. Salti I, Benard E, Detournay B, et al. A population-based study of

diabetes and its characteristics during the fasting month of Ramadan in 13

countries: results of the epidemiology of diabetes and Ramadan 1422/2001

(EPIDIAR) study. Diabetes Care. 2004; 27:2306-2311.

    6. EMA. Victoza(R) EU Summary of Product Characteristics. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001026/WC500050017.pdf

Last accessed 01.05.2015.

    7. Internal Calculations based on IMS Midas Quantum data. March 2015.

    8. FDA. Victoza(R) US prescribing information. Available at:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf Last

accessed 01.05.2015.

    Further Information

    Media:

    Katrine Sperling

    +45-4442-6718

    krsp@novonordisk.com;

    Michael Bachner (US)

    +1-609-664-7308 mzyb@novonordisk.com

    Investors:

    Kasper Roseeuw Poulsen

    +45-3079-4303

    krop@novonordisk.com;

    Melanie Raouzeos

    +45-3075-3479

    mrz@novonordisk.com;

    Daniel Bohsen

    +45-3079-6376

    dabo@novonordisk.com;

    Frank Daniel Mersebach (US)

    +1-609-235-8567

    fdni@novonordisk.com

    SOURCE: Novo Nordisk