Semaglutide Demonstrated Superior Glycaemic Control vs Insulin Glargine U100 in Adults with Type 2 Diabetes

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ORLANDO, Florida, May 28, 2016 /PRNewswire=KYODO JBN/ --

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Abstract #290

Findings from a phase 3a clinical trial for semaglutide, an investigational

glucagon-like peptide-1 (GLP-1) analogue, demonstrated that treatment with

semaglutide, administered once-weekly, significantly improved glycaemic control

compared to insulin glargine U100 in adults with type 2 diabetes. Results from

the SUSTAIN 4 trial were presented today at the American Association of

Clinical Endocrinologists 25th Annual Scientific and Clinical Congress (AACE)

in Orlando, US.[1]

The 30-week SUSTAIN 4 trial showed that, from a mean baseline HbA1c of 8.2%,

adults with type 2 diabetes receiving metformin with or without sulfonylurea,

achieved statistically significant and superior improvements in HbA1c

reductions of 1.2% and 1.6% when treated with 0.5 mg and 1.0 mg semaglutide,

respectively, vs a 0.8% reduction with insulin glargine U100 (p＜0.0001 for

both).[1] End of trial mean dose of insulin glargine U100 was 29 IU/day.

"Type 2 diabetes is a complex disease and many patients on insulin are still

uncontrolled," said Vanita Aroda, SUSTAIN 4 investigator and Physician

Investigator at the MedStar Health Research Institute, Hyattsville, MD, US.

"The results of SUSTAIN 4 are encouraging, as once-weekly semaglutide

demonstrated superior glycaemic control compared to insulin glargine U100 in

people that generally had a relatively long duration of type 2 diabetes."

More adults treated with 0.5 mg and 1.0 mg semaglutide achieved HbA1c targets

compared with insulin glargine U100: HbA1c ＜7% (57.5% and 73.3% vs 38.1%) and

less than or equal to6.5% (37.3% and 54.2% vs 17.5%).[1] Additionally, from a

mean baseline body weight of 93.4 kg, adults treated with 0.5 mg and 1.0 mg

semaglutide achieved statistically significant and superior reductions in mean

body weight of 3.5 kg/7.72 lb and 5.2 kg/11.46 lb compared to an increase of

1.2 kg/2.65 lb with insulin glargine U100 (p＜0.0001 for both).[1]

The most common adverse events observed for adults treated with 0.5 mg and 1.0

mg semaglutide were gastrointestinal (nausea: 21.3% and 22.2% vs insulin

glargine U100, 3.6%; diarrhoea: 16.3% and 19.2% vs insulin glargine U100, 4.4%;

vomiting: 6.6% and 10.3% vs insulin glargine U100, 3.1%). Rates of serious

adverse events were comparable across treatment groups (6.1% and 4.7% vs 5.0%).

Fewer adults reported severe or blood glucose-confirmed hypoglycaemia with

either semaglutide dose compared to insulin glargine U100 (4.4% and 5.6% vs

10.6%). The proportion of adults treated with 0.5 mg and 1.0 mg semaglutide

discontinuing treatment due to adverse events was 5.5% and 7.5% vs 1.1% for

insulin glargine U100.[1]

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.[2]

Semaglutide administered subcutaneously once-weekly is in phase 3 development

for the treatment of adults with type 2 diabetes.

About SUSTAIN 4

SUSTAIN 4 was a randomised, open-label, multicentre, multinational 30-week

trial investigating the safety and efficacy of semaglutide, administered

once-weekly, vs once-daily insulin glargine (U100/mL), both added on to

metformin with or without sulfonylurea in 1,089 adults with an overall type 2

diabetes duration of 8.6 years and who had not previously received any

insulin-based therapies. Secondary endpoints included change in body weight

from baseline after 30 weeks of treatment. The trial was conducted in

Argentina, Croatia, France, Germany, India, Macedonia, Mexico, the Netherlands,

Puerto Rico, Romania, Slovakia, Slovenia, South Africa, 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.    Aroda VR, Bain SC, Cariou B, et al. Efficacy and safety of once-weekly

semaglutide vs once-daily insulin glargine in insulin-naive subjects with type

2 diabetes (SUSTAIN 4). Abstract number 290. American Association of Clinical

Endocrinologists 25th Annual Scientific and Clinical Congress (AACE), Orlando,

FL, US; 25-29 May 2016.

2.    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