Ozempic(R) Provided Greater Weight Reductions for Adults With a Baseline BMI Greater Than or Equal to 25kg/m2 Than Those With Lower Baseline BMI Less Than 25kg/m2, in a SUSTAIN 7 Post-hoc Analysis

PR74106

ORLANDO, Florida, June 24, 2018 /PRNewswire=KYODO JBN/ -

Poster Presentation #1083-P

Ozempic(R) (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 greater than or equal to 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 (less than

25, 25- less than 30, 30- less than 35, greater than or equal to 35 kg/m2) with

Ozempic(R) 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(R) 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

(greater than or equal to 25 kg/m2) taking Ozempic(R) generally achieved

greater weight reductions than those with lower baseline BMI (<25 kg/m2).1

In addition, more people achieved weight reductions of greater than or equal to

5% and greater than or equal to 10% with Ozempic(R) 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(R) 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 (R) 0.5 and 1.0 mg and dulaglutide 1.5 mg).1 The most

common adverse events (greater than or equal to 5%) for both Ozempic(R) dosages

were GI adverse events.1

About Ozempic(R)

Ozempic(R) (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(R) 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(R) 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, Facebook, Twitter, LinkedIn, YouTube.   

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(R) Prescribing Information. Available at:

http://www.novo-pi.com/ozempic.pdf. Last accessed: May 2018.

4. Novo Nordisk. Ozempic(R) Canada Product Monograph. Available at

https://pdf.hres.ca/dpd_pm/00043163.PDF . Last accesed: May 2018.

5. EMA. Ozempic(R) (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(R) approved in Japan for the treatment of type 2

diabetes. Available at:

https://www.novonordisk.com/content/Denmark/HQ/www-novonordisk-com/en_gb/home/media/news-details.2178681.html.

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

Asa 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 Kjaer, +45-3079-3009, cnje@novonordisk.com

Source: Novo Nordisk