Ozempic® Superior in Lowering Blood Sugar and Weight Vs Placebo, Both in Combination with SGLT-2 Inhibitors

Bagsværd, Denmark (ots/PRNewswire) -

Novo Nordisk today announced publication of results from the
SUSTAIN 9 Phase 3b trial in The Lancet Diabetes & Endocrinology. The
objective of this 30 week trial was to assess the efficacy and safety
of Ozempic® (semaglutide) 1.0 mg when added to SGLT-2 inhibitor
(SGLT-2i) therapy.1 In SUSTAIN 9, adults with type 2 diabetes were
randomised to receive once-weekly semaglutide or placebo in addition
to an SGLT-2i, either as monotherapy or in combination with metformin
or sulfonylurea.1

The trial met its primary endpoint, with Ozempic® (semaglutide)
injection 1.0 mg demonstrating a statistically significant and
superior reduction in HbA1c of 1.5% vs 0.1% with placebo, both in
combination with SGLT2-i treatment, from an overall mean baseline of
8.0%.1 Additional findings of a secondary endpoint showed that
Ozempic® 1.0 mg demonstrated a statistically significant and superior
reduction in body weight of 4.7 kg vs 0.9 kg with placebo, from an
overall mean baseline of 91.7 kg.1

"Despite current treatment, almost 50% of people with type 2
diabetes are still living with uncontrolled blood sugar," said Mads
Krogsgaard Thomsen, executive vice president and chief science
officer of Novo Nordisk. "The results from SUSTAIN 9 demonstrated
that Ozempic® in combination with an SGLT-2 inhibitor is effective in
lowering blood sugar and reducing body weight. These data further
reinforce the results from across the SUSTAIN clinical development
programme and the benefits of Ozempic® that clinicians from many
countries are already seeing in their day-to-day practices."

Within the study, a statistically significant greater proportion
of people treated with Ozempic® 1.0 mg vs placebo (both in
combination with an SGLT-2i) achieved the American Diabetes
Association (ADA) HbA1C target of <7% (<53 mmol/mol), with 78.7% vs
18.7%, respectively.1 A statistically significant greater proportion
also met the more stringent American Association of Clinical
Endocrinologists (AACE) HbA1C target of <=6.5% (<=48 mmol/mol) with
Ozempic® 1.0 mg vs placebo (both in combination with an SGLT-2i),
with 56.1% vs 3.9% respectively.1

In SUSTAIN 9, the safety profile of Ozempic® 1.0 mg in combination
with SGLT-2i therapy was consistent with the overall SUSTAIN clinical
trial programme. The most common adverse event (AE) for Ozempic® was
nausea. Gastrointestinal AEs were reported in 37.3% and 13.2% of
people treated with Ozempic® 1.0 mg and placebo, respectively.
Serious AEs occurred in 4.7% and 4.0% of people, respectively. Severe
or blood glucose-confirmed hypoglycaemic events were reported in 4
people treated with Ozempic® 1.0 mg (2.7%) vs 0 people with placebo.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.2,3 Ozempic® was approved by the US Food and Drug
Administration on 5 December 2017, by Health Canada on 4 January
2018, by the European Commission on 8 February 2018, by the Japanese
Ministry of Health, Labour and Welfare on 23 March 2018, by
Swissmedic on 2 July 2018, and by the Brazilian National Health
Surveillance Agency on 6 August 2018.4-9

About SUSTAIN 9

SUSTAIN 9 is a double-blind, randomised, parallel-group Phase 3b
trial, which included 302 adults with type 2 diabetes, conducted
across six countries. Adults with type 2 diabetes and HbA1c
7.0-10.0%, with >=90 days' treatment of an SGLT-2i, either as
monotherapy or in combination with either metformin (71.5%) or
sulfonylurea (12.9%), were randomised 1:1 to receive once-weekly
Ozempic®(semaglutide) injection 1.0 mg, or a volume-matched placebo
for 30 weeks. The primary outcome was change in HbA1c from baseline
at Week 30. The primary and confirmatory analyses were based on
Multiple Imputation (MI) followed by ANCOVA.1

About the SUSTAIN clinical trial programme

The SUSTAIN clinical development programme for Ozempic® comprises
10 Phase 3 global clinical trials, including a cardiovascular
outcomes trial, which included people with type 2 diabetes and high
cardiovascular risk. The programme involved more than 8,700 adults
with type 2 diabetes in total (includes people from SUSTAIN 1-7 and
9).

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 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 43,200 people in 80 countries and markets its
products in more than 170 countries. For more information, visit
novonordisk.com (https://www.novonordisk.com/), Facebook (https://url
defense.proofpoint.com/v2/url?u=http-3A__www.facebook.com_novonordisk
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Further information

Media:

Mette Kruse Danielsen, +45 4442 3883, mkd@novonordisk.com

Ken Inchausti (US), +1 609 786 8316, kiau@novonordisk.com

Investors:

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

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

Valdemar Borum Svarrer, +45 3079 0301, jvls@novonordisk.com

Ann Søndermølle Rendbæk, +45 3075 2253, arnd@novonordisk.com

References

1. Zinman B, et al. Semaglutide once weekly as add-on to SGLT-2
inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised,
placebo-controlled trial. The Lancet Diabetes and Endocrinology.
2019. ePub ahead of print. DOI: https://doi.org/10.1016/S2213-8587
(19)30066-X.
2. EMA. Ozempic® Summary of Product Characteristics. Available at: ht
tp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_
Information/human/004174/WC500244163.pdf. Last accessed: March
2019.
3. FDA. Ozempic® US Prescribing Information. December 2017. Available
at: http://www.novo-pi.com/ozempic.pdf. Last accessed: March 2019.
4. Novo Nordisk. Ozempic® approved in Japan for the treatment of type
2 diabetes. Available at: https://www.novonordisk.com/content/Denm
ark/HQ/www-novonordisk-com/en_gb/home/media/news-details.2178681.h
tml. Last accessed: March 2019.
5. Novo Nordisk. Ozempic® approved in Canada for the treatment of
adults with type 2 diabetes. Available at: http://www.novonordisk.
ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/News/Ozempic%20
press%20release_Eng_01.08.2018_FINAL.pdf. Last accessed: March
2019.
6. Novo Nordisk. Company Announcement. Ozempic® (semaglutide)
approved in the US. Available from: https://www.novonordisk.com/co
ntent/Denmark/HQ/www-novonordisk-com/en_gb/home/media/news-details
.2154210.html. Last accessed: March 2019.
7. Novo Nordisk. Ozempic® (semaglutide) recommended for approval by
the European regulatory authorities. Available at: https://www.nov
onordisk.com/content/Denmark/HQ/www-novonordisk-com/en_gb/home/med
ia/news-details.2156392.html. Last accessed: March 2019.
8. Ozempic® (semaglutide) Brazil letter of marketing authorisation.
August 2018.
9. Swissmedic. Ozempic® (semaglutide) approval. July 2018. Available
at: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel
/authorisations/authorised-medicinal-products-with-new-active-subs
tances/semaglutidum.html. Last accessed: March 2019.

ots Originaltext: Novo Nordisk A/S
Im Internet recherchierbar: http://www.presseportal.de

Original-Content von: Novo Nordisk A/S, übermittelt durch news aktuell