Victoza® lowered the progression of kidney damage in adults with type 2 diabetes at high CV risk

Munich (ots/PRNewswire) -

This material is intended for global medical media only.

For journalistic assessment and preparation before publication.

Novo Nordisk today announced that the progression of kidney damage
was significantly lower with Victoza® treatment vs placebo, as
measured by urinary albumin creatinine ratio, both added to standard
of care in 9,340 adults with type 2 diabetes at high cardiovascular
(CV) risk. Similar significant results were observed between Victoza®
and placebo across subgroups (with no, mild or moderate renal
impairment).[1] The results were presented today at the 52nd Annual
Meeting of the European Association for the Study of Diabetes (EASD)
2016.[1]

New onset or worsening kidney disease was part of a pre-specified
secondary endpoint in the landmark LEADER CV outcomes trial. The
overall risk reduction of 22% was primarily driven by the component
of new onset of persistent macroalbuminuria (high levels of a protein
called albumin found in the urine), which occurred significantly less
(26%) in adults treated with Victoza® vs placebo.[1]

"Kidney disease is one of the more common long-term complications
of type 2 diabetes, affecting up to 40% of adults living with this
disease," said Dr Johannes Mann, LEADER investigator and Professor of
Medicine, Dept. of Nephrology & Hypertension, University of
Erlangen-Nuremberg, Germany. "These findings are clinically relevant
as they indicate that Victoza® may have the potential to reduce the
risk of kidney disease in adults with type 2 diabetes at high
cardiovascular risk."

Furthermore, a secondary analysis on hospitalisations for heart
failure (HF) demonstrated that Victoza® did not increase the risk of
hospitalisation for HF in adults with type 2 diabetes and a history
of HF vs placebo. In a pre-specified secondary analysis for LEADER,
Victoza® reduced hospitalisations for HF by 13% vs placebo across all
adults with or without a history of HF at baseline.[1]

The proportion of adults experiencing adverse events was similar
between the Victoza® and the placebo groups (62.3% vs 60.8%
respectively). The most common adverse events leading to the
discontinuation of Victoza® were gastrointestinal events. The
incidence of pancreatitis was non-significantly lower in the Victoza®
group than in the placebo group.[2]

About LEADER

LEADER was a multicentre, international, randomised, double-blind,
placebo-controlled trial investigating the long-term (3.5 - 5 years)
effects of Victoza® (liraglutide up to 1.8 mg) compared to placebo,
both in addition to standard of care, in people with type 2 diabetes
at high risk of major cardiovascular events.[2] Standard of care was
comprised of lifestyle modifications, glucose-lowering treatments and
cardiovascular medications.[3]

LEADER was initiated in September 2010 and randomised 9,340 people
with type 2 diabetes from 32 countries. The primary endpoint was the
first occurrence of a composite cardiovascular outcome comprising
cardiovascular death, non-fatal myocardial infarction (heart attack)
or non-fatal stroke.[2]

Over a median follow-up of 3.8 years, Victoza® significantly
reduced the risk of the composite primary endpoint of cardiovascular
death, non-fatal myocardial infarction or non-fatal stroke by 13% vs
placebo. There was a significant 22% reduction in cardiovascular
death with Victoza® treatment vs placebo and non-significant
reductions in non-fatal myocardial infarction and non-fatal
stroke.[2]

Kidney disease was assessed by the composite renal outcome,
defined as: high levels of a protein called albumin found in the
urine (new onset of persistent macroalbuminuria); kidney filtration
function (persistent doubling of serum creatinine); need for dialysis
(continuous renal replacement therapy); or death due to kidney
disease.[2]

About kidney disease and type 2 diabetes

Diabetes significantly increases the risk of developing diabetic
nephropathy, which is the leading cause of end-stage kidney disease
(or kidney failure). Diabetic nephropathy affects 30-40% of those
with diabetes and males with type 2 diabetes have a six-fold
increased risk of developing this condition compared to those without
type 2 diabetes. Furthermore, the presence of diabetic nephropathy is
known to be a significant risk factor for cardiovascular disease.[4]

About Victoza®

Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1)
analogue with an amino acid sequence 97% similar to endogenous human
GLP-1.

Victoza® was approved in the EU in 2009[5] and is commercially
available in more than 85 countries, treating more than 1 million
people with type 2 diabetes globally.[6] In Europe, Victoza® is
indicated for the treatment of adults with type 2 diabetes to achieve
glycaemic control as monotherapy, when metformin is considered
inappropriate, and 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.[5] In
the US, Victoza® was approved in 2010 as an adjunct to diet and
exercise to improve blood glucose control in adults with type 2
diabetes.[7]

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 42,300 people in 75 countries and markets its products
in more than 180 countries. For more information, visit
novonordisk.com (http://www.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)

Further information

Media:

Katrine Sperling

+45 4442 6718

krsp@novonordisk.com

Åsa Josefsson

+45 3079 7708

aajf@novonordisk.com

Investors:

Peter Hugreffe Ankersen

+45 3075 9085

phak@novonordisk.com

Melanie Raouzeos

+45 3075 3479

mrz@novonordisk.com

Hanna Ögren

+45 3079 8519

haoe@novonordisk.com

Kasper Veje (US)

+1 609 235 8567

kpvj@novonordisk.com

References

1. Results of the liraglutide effect and action in diabetes -
evaluation of cardiovascular outcome results (LEADER) trial.
Scientific Sessions at the 52nd Annual Meeting of the European
Association for the Study of Diabetes (EASD) 2016. 15 September
2016.
2. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and
cardiovascular outcomes in type 2 diabetes. New England Journal of
Medicine 2016; 375:311-322.
3. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and
cardiovascular outcomes in type 2 diabetes. Supplementary
Information. New England Journal of Medicine 2016; 375:311-322.
4. Gallagher H, Suckling RJ. Diabetic nephropathy: where are we on
the journey from pathophysiology to treatment? Diabetes, Obesity
and Metabolism 2016; 18:641-647.
5. EMA. Victoza® EU summary of product characteristics. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produc
t_Information/human/001026/WC500050017.pdf. Last accessed:
September 2016.
6. Internal Calculations based on IMS Midas Quantum data. March 2016.
7. FDA. Victoza® US prescribing information. April 2016. Available
at: http://www.novo-pi.com/victoza.pdf. Last accessed: August
2016.

ots Originaltext: Novo Nordisk A/S
Im Internet recherchierbar: http://www.presseportal.de