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

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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 information, visit
novonordisk.com [http://novonordisk.com ], Facebook
[http://www.facebook.com/novonordisk ], Twitter
[http://www.twitter.com/novonordisk ], LinkedIn
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[http://www.Youtube.com/novonordisk ].

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://la
btestsonline.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/EP
AR_-_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

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