| [PRNewswire] Ozempic(R) Provided Greater Weight Reductions for Adults With a |
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Baseline BMI ≥25kg/m2 Than Those With Lower Baseline BMI <25kg/m2, in a SUSTAIN 7 Post-hoc Analysis
-- Poster Presentation #1083-P
(ORLANDO, Florida, June 23, 2018 PRNewswire=연합뉴스) 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 ≥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(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 (≥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 ≥5% and ≥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 (≥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 [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, Bluher 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 Kjær, +45-3079-3009, cnje@novonordisk.com
Source: Novo Nordisk
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