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

          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 [http://www.linkedin.com/company/novo-nordisk ], YouTube [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://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

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          Michael Bachner (US) +1-609-664-7308 [email protected]

          Investors:

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          Melanie Raouzeos +45-3075-3479 [email protected]
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          Frank Daniel Mersebach (US) +1-609-235-8567 [email protected]

          Source: Novo Nordisk