Ozempic(R)Superior in Lowering Blood Sugar and Weight Vs Placebo, Both in Combination with SGLT-2 Inhibitors
Ozempic(R)Superior in Lowering Blood Sugar and Weight Vs Placebo, Both in Combination with SGLT-2 Inhibitors
PR77683
BAGSVAERD, Denmark, March 5, 2019 /PRNewswire=KYODO JBN/ --
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(R) (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(R) (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(R) 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(R) 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(R) 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(R) 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(R)
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(R) 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(R) was nausea.
Gastrointestinal AEs were reported in 37.3% and 13.2% of people treated with
Ozempic(R) 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(R) 1.0 mg (2.7%) vs 0
people with placebo.[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.[2],[3] Ozempic(R) 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(R)(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(R) 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, [
] Twitter,[
] LinkedIn,[
] YouTube.[
]
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(R) Summary of Product Characteristics. Available at:
Last accessed: March 2019.
3. FDA. Ozempic(R) US Prescribing Information. December 2017. Available at:
http://www.novo-pi.com/ozempic.pdf. Last accessed: March 2019.
4. Novo Nordisk. Ozempic(R) approved in Japan for the treatment of type 2
diabetes. Available at:
Last accessed: March 2019. Novo Nordisk.
5. Ozempic(R) approved in Canada for the treatment of adults with type 2
diabetes. Available at:
Last accessed: March 2019.
6. Novo Nordisk. Company Announcement. Ozempic(R) (semaglutide) approved in
the US. Available from:
Last accessed: March 2019.
7. Novo Nordisk. Ozempic(R) (semaglutide) recommended for approval by the
European regulatory authorities. Available at:
Last accessed: March 2019.
8. Ozempic(R) (semaglutide) Brazil letter of marketing authorisation.
August 2018.
9. Swissmedic. Ozempic(R) (semaglutide) approval. July 2018. Available at:
Last accessed: March 2019.
Source: Novo Nordisk
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