BOSTON, MA, June 6, 2015 /CNW/ - This material is intended for medical
non-UK media only. For journalistic assessment and preparation before
New findings showed that adults with type 2 diabetes treated with
Victoza® , in combination with metformin, experienced similar improvements in
blood glucose control while fasting during Ramadan (four weeks)
compared with sulfonylurea (SU) plus metformin. People treated with Victoza® also demonstrated significantly better weight loss and fewer confirmed
hypoglycaemic episodes compared with those treated with sulfonylurea
during Ramadan. Findings from the LIRA-Ramadan™ 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® sustained blood glucose control during four weeks of Ramadan, with
similar reductions in fructosamine levels compared with sulfonylurea
(-12.8 µmol/L vs. -16.4 µmol/L; estimated treatment difference [ETD]
3.51 µmol/L [-5.26;12.28]; P=0.43). Testing fructosamine allows the effectiveness of diabetes treatment to
be reliably evaluated after a couple of weeks., During Ramadan, patients treated with Victoza® experienced fewer confirmed hypoglycaemic episodes compared with people
treated with sulfonylurea (2.0% vs. 4.3%), even though the Victoza® group had lower fructosamine concentration at the start of Ramadan. In
addition, greater weight loss was observed in people treated with
Victoza® 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).
"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™ 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, the majority of which have been estimated to have type 2 diabetes. 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, which takes place 18 June - 17 July this year.
In the LIRA-Ramadan™ study, people treated with Victoza® 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® 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 µmol/L vs. -29.3 µmol/L; ETD -10.3 µmol/L [-18.7; -1.89]; P=0.0165).
The percentage of patients experiencing adverse events (AEs) during
Ramadan was similar in the Victoza® and sulfonylurea groups (23.7% vs. 20.9%), with gastrointestinal side
effects more common with Victoza® treatment (10.5% vs. 3.7%). Overall, a low incidence of severe AEs was
observed (Victoza®, 1.3% vs. sulfonylurea,0%).
The most common AEs seen during the entire study period were
gastrointestinal (Victoza®, 56.7% vs. sulfonylurea, 9.4%), and these included nausea, diarrhoea,
vomiting, abdominal pain and abdominal distension.
About the Study
The study was a 33-week, open-label, multinational clinical trial
involving 343 people (172 for Victoza®, 171 for sulfonylurea). The study included people with type 2 diabetes
with intent to fast during Ramadan, HbA1c 7-10%, BMI ≥20 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® (1.8 mg) or continue pre-trial sulfonylurea, both in combination with
pre-trial metformin. Victoza® 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.
Victoza® (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® 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.[*], In addition, Victoza® reduces body weight and body fat mass through mechanisms involving
reduced appetite and lowered energy intake.
Victoza® 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., In Europe, Victoza® 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. In the US, Victoza® was approved on 25 January 2010 as an adjunct to diet and exercise to
improve blood glucose control in adults with type 2 diabetes.
[*]Hypoglycaemia has primarily been observed when Victoza® 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, Facebook, Twitter, LinkedIn, YouTube.
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
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.
Lab Tests Online. Fructosamine testing. Available at: http://labtestsonline.org.uk/understanding/analytes/fructosamine/tab/test/ Accessed on: 23/05/2015.
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.
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.
EMA. Victoza® 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.
Internal Calculations based on IMS Midas Quantum data. March 2015.
FDA. Victoza® US prescribing information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf Last accessed 01.05.2015
SOURCE Novo Nordisk
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