Novo Nordisk A/S : New phase 3 study shows efficacy and safety of Victoza® for the treatment of type 2 diabetes in adults with moderate renal impairment

San Francisco, US, 14 June 2014 - Data from a new phase 3 study demonstrated that once-daily Victoza® (liraglutide) provided greater glycaemic control versus placebo with no worsening of renal function in adults with type 2 diabetes and moderate renal impairment.1 The data were presented today at the 74th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, California. Renal impairment is one of the more challenging and common long-term complications of diabetes and limits the use of available antidiabetic treatment options.2
The 26-week, double-blind, randomised, controlled study investigated the efficacy and safety of Victoza® compared with placebo when added to pre-existing oral antidiabetic treatment, insulin or a combination thereof. The study showed that adults with type 2 diabetes and moderate renal impairment, defined as those with stage 3 chronic kidney disease (estimated glomerular filtration rate [eGFR] 30-59 ml/min/1.73 m2; Modification of Diet in Renal Disease [MDRD]), treated with Victoza® had significantly greater improvements in mean HbA1c (a measure of blood glucose levels) (-1.05% vs -0.38%; ETD -0.66% [-0.90;-0.43] p<0.0001), were more likely to achieve the target level of HbA1c<7% (52.8% vs 19.5%; p<0.0001) and experienced significantly greater weight loss from baseline (-2.41 kg/5.31 lbs vs -1.09 kg/2.40 lbs; ETD -1.32 kg [-2.24;-0.40] p=0.0052) versus placebo. No worsening of renal function and a lower incidence of hypoglycaemia with treatment of Victoza ® compared with placebo were observed in the study.1
"Renal impairment is very common in patients with type 2 diabetes, especially in adults over 65 years of age", said Melanie Davies, professor of Diabetes Medicine and honorary consultant, Diabetes Research Centre, University of Leicester, UK. "Of the therapies available for type 2 diabetes, it is essential we have treatment options specifically for patients with associated renal impairment."
The most common adverse events (AEs) seen in this study were gastrointestinal. These included nausea (21.4% vs 4.4% placebo), vomiting (12.1% vs 2.2%), diarrhoea (7.1%
vs 2.9%) and constipation (5.7% vs 1.5%). Additional frequent AEs (≥5%) were renal

Corporate Communications

Novo Allé

2880 Bagsværd

Denmark

Telephone:

+45 4444 8888

APROM ID: 6171

Date of Approval: June 2014

Internet: www.novonordisk.com CVR no:

24 25 67 90

impairment (5% vs 5.8% placebo), nasopharyngitis, usually referred to as the common cold (5% vs 11.7%), headache (5% vs 2.9%), increased lipase (15% vs 8.8%) and decreased GFR (6.4% vs 5.1%).

The phase 3 study was a multinational study involving 277 adults. People with moderate renal impairment were defined as those with stage 3 chronic kidney disease (eGFR 30-
59). Participants were randomised to either Victoza® (liraglutide) 1.8 mg, the highest
dosage available, or placebo as add-on to existing oral antidiabetic treatment and/or insulin therapy. The mean age of participants was 68 and 66.3 years for people treated with Victoza® or placebo, respectively. The primary endpoint was percentage change in HbA1c from baseline. Other endpoints included HbA1c to target <7% and body-weight change from baseline. Renal function was measured by eGFR change 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 food intake.
Victoza® was launched in the EU in 2009 and is commercially available in more than 68 countries globally. Currently, there are more than 830,000 patients receiving Victoza® worldwide.3 In the US, Victoza® was approved on 25 January 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.

†Hypoglycaemia has primarily been observed when Victoza® is combined with a sulfonylurea.

Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately

40,000 employees in 75 countries, and markets its products in more than 180 countries. For more

information, visit novonordisk-us.com.

Corporate Communications

Novo Allé

2880 Bagsværd

Denmark

Telephone:

+45 4444 8888

APROM ID: 6171

Date of Approval: June 2014

Internet: www.novonordisk.com CVR no:

24 25 67 90

1 Davies M, Atkin S, Bain S, et al. Efficacy and Safety of Liraglutide versus Placebo as Add-on to Existing Diabetes Medication in Subjects with Type 2 Diabetes (T2DM) and Moderate Renal Impairment (LIRA-RENAL). Guided Audio Poster Tour 0965-P at 74th Scientific Sessions of the American Diabetes Association (ADA), 15 June 2014.

2Gonzalez Suarez ML, Thomas DB, Barisoni L, Fornoni A. Diabetic nephropathy: Is it time yet for

routine kidney biopsy? World Journal of Diabetes 2013; 4(6):245-255.

3 Internal Calculations based on IMS Midas Quantum data, March 2014.

Corporate Communications

Novo Allé

2880 Bagsværd

Denmark

Telephone:

+45 4444 8888

APROM ID: 6171

Date of Approval: June 2014

Internet: www.novonordisk.com CVR no:

24 25 67 90

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