Semaglutide Reduced Major Cardiovascular Events by 26% in Adults With Type 2 Diabetes at High Cardiovascular Risk

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MUNICH, Sep. 16 /PRNewswire=KYODO JBN/--

HOLD UNTIL 16/09/2016 16:31 SYDNEY TIME

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    Novo Nordisk today announced that semaglutide, an investigational

glucagon-like peptide-1 (GLP-1) analogue administered once-weekly,

significantly reduced the risk of the primary composite endpoint of time to

first occurrence of either cardiovascular (CV) death,  non-fatal myocardial

infarction (heart attack) or non-fatal stroke by 26% vs placebo, when added to

standard of care in 3,297 adults with type 2 diabetes at high CV risk.[1]  

These results were based on an accumulation of first major adverse CV events

(MACE) in 254 people.[1]

    The main results from SUSTAIN 6 were presented today at the 52nd Annual

Meeting of the European Association for the Study of Diabetes (EASD) 2016[2]

and also published in the New England Journal of Medicine.[1]

    Furthermore, there was a significant 39% decrease in non-fatal stroke and a

non-significant 26% decrease in non-fatal myocardial infarction and a neutral

outcome (2% decrease) in CV death after only two years of treatment.[1]

    "The reduction in cardiovascular events observed with semaglutide in

SUSTAIN 6 is notable given the small study population and the short trial

duration," said Dr Steven Marso, SUSTAIN 6 investigator and the lead author for

the New England Journal of Medicine publication of SUSTAIN 6. "These findings

are clinically relevant, as cardiovascular disease is the leading cause of

death in people with type 2 diabetes and new treatment options that can also

reduce the risk of cardiovascular events are needed."

    In this outcomes trial, from an overall mean baseline of 8.7%, semaglutide

0.5 mg and 1.0 mg significantly reduced HbA1c by -1.1% and -1.4% vs -0.4% for

both placebo 0.5 mg and 1.0 mg at 104 weeks, when added to standard of care. In

addition, from a mean baseline of 92.1 kg, adults treated with semaglutide 0.5

mg and 1.0 mg experienced superior and sustained weight loss of -3.6 kg and

-4.9 kg, vs -0.7 kg for placebo 0.5 mg and -0.5 kg for placebo 1.0 mg.[1]

    Fewer serious adverse events were seen with semaglutide vs placebo;

however, treatment discontinuation due to adverse events was more frequent with

semaglutide, mainly due to gastrointestinal events. The incidence of

pancreatitis was lower with semaglutide vs placebo. In terms of microvascular

complications, significantly fewer people treated with semaglutide (62 [3.8%])

vs placebo (100 [6.1%]) had new onset or worsening nephropathy while

significantly more people treated with semaglutide (50 [3.0%]) vs placebo (29

[1.8%])  experienced diabetic retinopathy complications.[1]

    "The results of SUSTAIN 6 support the strong potential of once-weekly

semaglutide in type 2 diabetes treatment and we look forward to regulatory

submission later this year," said Mads Krogsgaard Thomsen, executive vice

president and chief science officer of Novo Nordisk. "The SUSTAIN 6 results

further strengthen the clinical evidence for the Novo Nordisk GLP-1 receptor

agonist portfolio with the finding of additional benefits beyond glycaemic

control and weight loss in adults with type 2 diabetes at high cardiovascular

risk."

    About semaglutide

    Semaglutide is a once-weekly investigational analogue of human

glucagon-like peptide-1 (GLP-1) that stimulates insulin and suppresses glucagon

secretion in a glucose-dependent manner, while decreasing appetite and food

intake.[3] With SUSTAIN 6, semaglutide, administered subcutaneously

once-weekly, has completed six phase 3a clinical trials for the treatment of

adults with type 2 diabetes.

    About SUSTAIN 6

    SUSTAIN 6 was a multicentre, international, randomised, double-blind,

placebo-controlled pre-marketing CV outcomes trial (CVOT) investigating the

long-term effects of semaglutide (0.5 mg and 1.0 mg) administered once-weekly,

compared to placebo, when added to standard of care, in adults with type 2

diabetes at high risk of CV events. Standard of care included lifestyle

modifications, glucose-lowering treatments and CV medications. The trial was

initiated in February 2013 and randomised 3,297 adults with type 2 diabetes

from 20 countries that were treated for 104 weeks.[1]

    SUSTAIN 6 is the first dedicated pre-marketing CVOT in a type 2 diabetes

population to report data. SUSTAIN 6 was designed to assess non-inferiority,

i.e. demonstrate no increased risk of major CV events vs placebo, when added to

standard of care. Superiority testing was not part of the pre-specified

analysis. The primary endpoint was the first occurrence of a composite CV

outcome comprising CV death, non-fatal myocardial infarction or non-fatal

stroke.[1]

    About the SUSTAIN clinical programme

    SUSTAIN (Semaglutide Unabated Sustainability in Treatment of Type 2

Diabetes) is a clinical programme for semaglutide, administered once-weekly,

that comprises six phase 3a global clinical trials encompassing more than 7,000

adults with type 2 diabetes as well as two Japanese trials encompassing around

1,000 adults with type 2 diabetes.

    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;      

    Asa 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 Ogren

    +45-3079-8519

    haoe@novonordisk.com

    Kasper Veje (US)

    +1-609-235-8567

    kpvj@novonordisk.com

    References

    1) Marso SP, Bain S, Consoli A, et al. Semaglutide and cardiovascular

outcomes, efficacy and safety in type 2 diabetes. New England Journal of

Medicine. 2016; In Press.

    2) Results of the SUSTAIN 6 trial. Scientific Sessions at the 52nd Annual

Meeting of the European Association for the Study of Diabetes (EASD 2016). 16

September 2016.

    3) Nauck MA, Petrie JR, Sesti G, et al. A phase 2, randomized, dose-finding

study of the novel once-weekly human GLP-1 analog, semaglutide, compared with

placebo and open-label liraglutide in patients with type 2 diabetes. Diabetes

Care. 2015; 39:231-241.

   SOURCE: Novo Nordisk