Ozempic® Provided Greater Weight Reductions for Adults With a Baseline BMI >=25kg/m2 Than Those With Lower Baseline BMI <25kg/m2, in a SUSTAIN 7 Post-hoc Analysis

Orlando, Florida (ots/PRNewswire) -

Poster Presentation #1083-P

Ozempic® (semaglutide) 0.5 mg or 1.0 mg provided greater weight
reductions vs dulaglutide 0.75 mg or 1.5 mg, respectively, in adults
with type 2 diabetes, regardless of baseline body mass index (BMI),
with the greatest reductions occurring in adults with a baseline BMI
>=25 kg/m2. While the primary endpoint of SUSTAIN 7 was change in
HbA1c, this post-hoc exploratory analysis examined the secondary
endpoint of change in body weight by baseline BMI.1 The results will
be presented 24 June, 2018 at the American Diabetes Association's
78th Scientific Sessions (ADA) in Orlando, US.

Greater weight reductions were demonstrated across all BMI
subgroups (<25, 25-<30, 30-<35, >=35 kg/m2) with Ozempic® 0.5 mg vs
dulaglutide 0.75 mg (range of weight reduction across all subgroups:
3.6-5.5 kg vs 0.9-3.4 kg) and with Ozempic® 1.0 mg vs dulaglutide 1.5
mg (range of weight reduction across all subgroups: 5.2-7.6 kg vs
2.0-3.8 kg), from a mean baseline of 95.2 kg.1 Adults with a higher
baseline BMI (>=25 kg/m2) taking Ozempic® generally achieved greater
weight reductions than those with lower baseline BMI (<25 kg/m2).1

In addition, more people achieved weight reductions of >=5% and
>=10% with Ozempic® vs dulaglutide in all BMI subgroups.1

"Globally, up to ninety percent of people with type 2 diabetes are
overweight or have obesity.2 Therefore, it is important to consider
how to manage weight in this population," said Dr Adie Viljoen,
SUSTAIN 7 chief investigator and consultant chemical pathologist,
East and North Hertfordshire NHS Trust, UK. "Based on the SUSTAIN
clinical trial programme, Ozempic® can help people living with type 2
diabetes manage their HbA1C and has the potential to help them lose
some weight."

Across BMI subgroups, fewer people reported gastrointestinal (GI)
adverse events with the low dulaglutide dose (0.75 mg) compared with
the other three treatment groups (Ozempic® 0.5 and 1.0 mg and
dulaglutide 1.5 mg).1 The most common adverse events (>=5%) for both
Ozempic® dosages were GI adverse events.1

About Ozempic®

Ozempic® (semaglutide) is a once-weekly analogue of human
glucagon-like peptide-1 (GLP-1) indicated as an adjunct to diet and
exercise to improve glycaemic control in adults with type 2
diabetes.3 Ozempic® was approved by the U.S. Food and Drug
Administration on 5 December, 2017, by Health Canada on 4 January,
2018, by the European Commission on 9 February, 2018 and on 23 March
by the Japanese Ministry of Health, Labour and Welfare.3-6

About the SUSTAIN clinical trial programme

The SUSTAIN global clinical development programme for Ozempic®
comprises eight phase 3a trials, encompassing more than 8,000 adults
with type 2 diabetes. The phase 3a programme involves a broad range
of people with type 2 diabetes, including some with high
cardiovascular risk profiles.

The primary analysis of the SUSTAIN 7 trial was published in The
Lancet Diabetes & Endocrinology earlier this year. The primary
outcome measure was change in HbA1c from baseline after 40 weeks of
treatment. Change in body weight from baseline to week 40 was a
predefined secondary endpoint.7 In this post-hoc exploratory
analysis, which was conducted using Mixed Models for Repeated
Measurements, the interaction effect between treatment and subgroup
was not statistically significant (semaglutide 0.5 mg vs dulaglutide
0.75 mg: p= 0.9118; semaglutide 1.0 mg vs dulaglutide 1.5 mg: p=
0.8175).1

About Novo Nordisk

Novo Nordisk is a global healthcare company with 95 years of
innovation and leadership in diabetes care. This heritage has given
us experience and capabilities that also enable us to help people
defeat obesity, haemophilia, growth disorders and other serious
chronic diseases. Headquartered in Denmark, Novo Nordisk employs
approximately 42,700 people in 79 countries and markets its products
in more than 170 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).

References:

1. Viljoen A, Blüher M, Chow F, et al. Semaglutide reduces body
weight vs dulaglutide across baseline BMI subgroups in SUSTAIN 7.
Abstract 1083-P. 78th Scientific Sessions of the American Diabetes
Association (ADA), Orlando, USA; 22-26 June 2018.

2. World Health Organization. Global Strategy on Diet, Physical
Activity and Health.
http://www.who.int/dietphysicalactivity/media/en/gsfs_obesity.pdf.
Updated 2003. Last accessed: May 2018.

3. Novo Nordisk. Ozempic® Prescribing Information. Available at:
http://www.novo-pi.com/ozempic.pdf. Last accessed: May 2018.

4. Novo Nordisk. Ozempic® Canada Product Monograph. Available at
https://pdf.hres.ca/dpd_pm/00043163.PDF . Last accesed: May 2018.

5. EMA. Ozempic® (semaglutide) SmPC. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR
Product_Information/human/004174/WC500244163.pdf. Last accessed: May
2018.

6. Novo Nordisk. Ozempic® approved in Japan for the treatment of
type 2 diabetes. Available at: https://www.novonordisk.com/content/De
nmark/HQ/www-novonordisk-com/en_gb/home/media/news-details.2178681.ht
ml. Last accessed: May 2018.

7. Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide once weekly
versus dulaglutide once weekly in patients with type 2 diabetes
(SUSTAIN 7): a randomised, open-label, phase 3b trial. The Lancet
Diabetes & Endocrinology. 2018.

Further information

Media:

Katrine Sperling, +45-4442-6718, krsp@novonordisk.com

Åsa Josefsson, +45-3079-7708, aajf@novonordisk.com

Michael Bachner (US), +1-609-664-7308, mzyb@novonordisk.com

Investors:

Peter Hugreffe Ankersen, +45-3075-9085, phak@novonordisk.com

Anders Mikkelsen, +45-3079-4461, armk@novonordisk.com

Christina Kjær, +45-3079-3009, cnje@novonordisk.com

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