Semaglutide Demonstrated Superior Improvements in Glycaemic Control vs Sitagliptin (SUSTAIN 2) and Exenatide ER (SUSTAIN 3) in Two Clinical Trials in Adults With Type 2 Diabetes

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NEW ORLEANS, June 13, 2016 /PRNewswire=KYODO JBN/ --

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    Abstracts 185-OR and 187-OR

    Findings from two phase 3a clinical trials for semaglutide, an

investigational glucagon-like peptide-1 (GLP-1) analogue, were presented today

at the American Diabetes Association 76th Scientific Sessions.[1],[2] In the

SUSTAIN 2 trial, 0.5 mg and 1.0 mg semaglutide administered once-weekly

significantly improved glycaemic control compared to sitagliptin (100 mg), a

dipeptidyl peptidase-4 (DPP-4) inhibitor, in adults with type 2 diabetes.[1] In

the SUSTAIN 3 trial, 1.0 mg semaglutide administered once-weekly significantly

improved glycaemic control compared to 2.0 mg exenatide extended-release (ER) ,

a GLP-1 receptor agonist, in adults with type 2 diabetes.[2]

    The SUSTAIN 2 trial showed that from a mean baseline HbA1c of 8.1%, adults

with type 2 diabetes treated with 0.5 mg and 1.0 mg semaglutide achieved

superior HbA1c reductions of 1.3% and 1.6%, respectively, vs 0.5% with 100 mg

sitagliptin at 56 weeks (both p＜0.0001), as add-on to metformin and/or

thiazolidinediones.[1]

    In the 56-week SUSTAIN 3 trial, adults with type 2 diabetes and a mean

baseline HbA1c of 8.3% achieved a superior HbA1c reduction of 1.5% when treated

with 1.0 mg semaglutide vs 0.9% with 2.0 mg exenatide ER (p＜0.0001), as add-on

to one or two oral antidiabetics (metformin, sulfonylurea or

thiazolidinediones).[2]

    "Many people with type 2 diabetes struggle to reach individualised

treatment goals," said Bo Ahren, Professor of Clinical Metabolic Research at

the Department of Clinical Sciences, Lund University, Sweden. "The superior

glucose reductions achieved with once-weekly semaglutide vs sitagliptin in

SUSTAIN 2 are encouraging as new treatment options are needed to address these

treatment goal challenges."

    More adults with type 2 diabetes achieved the HbA1c target of ＜7% when

treated with 0.5 mg and 1.0 mg semaglutide vs sitagliptin in SUSTAIN 2 (69% and

78% vs 36%)[1] and with 1.0 mg semaglutide vs exenatide ER in SUSTAIN 3 (67% vs

40%).[2]

    In addition, from a mean baseline body weight of 89.5 kg, adults with type

2 diabetes achieved significantly greater reductions in mean body weight when

treated with 0.5 mg and 1.0 mg semaglutide vs sitagliptin in SUSTAIN 2 (4.3 kg

and 6.1 kg vs 1.9 kg; both p＜0.0001).[1] Similarly, from a mean baseline body

weight of 95.8 kg, adults with type 2 diabetes achieved significantly greater

reductions in mean body weight when treated with 1.0 mg semaglutide vs

exenatide ER in SUSTAIN 3 (5.6 kg vs 1.9 kg; p＜0.0001).[2]

    "The superior and sustained glycaemic control and weight loss demonstrated

in SUSTAIN 2 and 3 add to the growing clinical evidence for our next-generation

GLP-1 analogue, once-weekly semaglutide," said Mads Krogsgaard Thomsen,

executive vice president and chief science officer of Novo Nordisk. "We are

excited about these results and look forward to further data from the

comprehensive SUSTAIN clinical trial programme being presented later this year."

    In SUSTAIN 2, the most common adverse events observed for adults treated

with 0.5 mg and 1.0 mg semaglutide and sitagliptin were gastrointestinal (43.5%

and 39.9% vs 23.6%). Comparable rates of serious adverse events were observed

for all treatment groups (7.3% and 7.3% vs 7.1%). The proportions of adults

discontinuing 0.5 mg, 1.0 mg or 100 mg sitagliptin due to adverse events were

8.1% and 9.5% vs 2.9%, respectively.[1]

    Similarly, in SUSTAIN 3, the most common adverse events observed for adults

treated with 1.0 mg semaglutide and exenatide ER were also gastrointestinal

(41.8% and 33.3%). Fewer adults reported injection site reactions with 1.0 mg

semaglutide (1.2%) compared with exenatide ER (22.0%). The rates of serious

adverse events observed for adults treated with 1.0 mg semaglutide compared

with exenatide ER were 9.4% and 5.9%, respectively. The proportions of adults

discontinuing due to adverse events were 9.4% and 7.2%.[2]

    About semaglutide

    Semaglutide is an investigational analogue of native human glucagon-like

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

a glucose-dependent manner, as well as decreases appetite and food intake.[3]

Semaglutide administered subcutaneously once-weekly is in phase 3 development

for the treatment of adults with type 2 diabetes.

    About SUSTAIN 2

    SUSTAIN 2 is a randomised, double-blind, double-dummy, multicentre,

multinational 56-week trial investigating the safety and efficacy of

semaglutide, administered once-weekly, vs sitagliptin, a once-daily DPP-4

inhibitor, in 1,231 adults with type 2 diabetes, where both drugs were added on

to metformin and/or thiazolidinediones. The primary endpoint was change in

HbA1c from baseline after 56 weeks of treatment. Secondary endpoints included

change in body weight from baseline after 56 weeks of treatment. The trial was

conducted in Argentina, Bulgaria, Czech Republic, Hong Kong, Hungary, India,

Japan, Mexico, Norway, Portugal, Romania, Russia, South Africa, Spain, Sweden,

Thailand, Turkey and Ukraine.

    About SUSTAIN 3

    SUSTAIN 3 is a randomised, open-label, multicentre, multinational 56-week

trial investigating the safety and efficacy of semaglutide, administered

once-weekly, vs 2.0 mg exenatide extended release (ER) once-weekly as add-on to

one or two oral antidiabetic treatments in 813 adults with type 2 diabetes. The

primary endpoint was change in HbA1c from baseline after 56 weeks of treatment.

Secondary endpoints included change in body weight from baseline after 56 weeks

of treatment. The trial was conducted in Argentina, Croatia, Finland, France,

Germany, Greece, Italy, the Netherlands, Puerto Rico, Serbia, Switzerland, UK

and the US.

    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

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

1,000 people 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 41,600 people in

75 countries and markets its products in more than 180 countries. For more

information, visit 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

     Kasper Veje (US)

     +1-609-235-8567

     kpvj@novonordisk.com

     References

    1. Ahren B, Comas LM, Kumar H, et al. Efficacy and safety of once-weekly

semaglutide vs sitagliptin as add-on to metformin and/or thiazolidinediones

after 56 weeks in subjects with type 2 diabetes (SUSTAIN 2). Abstract number

185-OR. American Diabetes Association 76th Scientific Session, New Orleans, US;

10-14 June 2016.

    2. Ahmann A, Capehorn M, Charpentier G, et al. Efficacy and safety of

once-weekly semaglutide vs exenatide ER after 56 weeks in subjects with type 2

diabetes (SUSTAIN 3). Abstract number 187-OR. American Diabetes Association

76th Scientific Session, New Orleans,  US; 10-14 June 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