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

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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 <=6.5% (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

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

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-naïve 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.

ots Originaltext: Novo Nordisk A/S
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