Mar 4, 2019   SOURCE: PR NewsWire

Ozempic® superior in lowering blood sugar and weight vs placebo, both in combination with SGLT-2 inhibitors

PLAINSBORO, N.J., March 4, 2019 /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) injection 1 mg in combination with SGLT-2 inhibitor (SGLT-2i) therapy.(1) In SUSTAIN 9, adults with type 2 diabetes were randomized to receive once-weekly semaglutide or placebo in addition to an SGLT-2i, either as monotherapy or in combination with metformin or a sulfonylurea.(1) Ozempic® (semaglutide) 0.5 mg or 1 mg is an injectable prescription medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.

The trial met its primary endpoint, with Ozempic(®) (semaglutide) injection 1 mg demonstrating a statistically significant and superior reduction in A1C of 1.5% vs 0.1% with placebo (p<0.0001), 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 mg demonstrated a statistically significant and superior reduction in body weight of 4.7 kg vs 0.9 kg with placebo (p<0.0001), 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(®) combined with an SGLT-2 inhibitor is effective in lowering blood sugar and reducing body weight [as a secondary endpoint]. These data further reinforce the results from across the SUSTAIN clinical development program 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 mg vs placebo, both in combination with an SGLT-2i, achieved the American Diabetes Association (ADA) A1C target of <7% (<53 mmol/mol), with 78.7% vs 18.7%, respectively (p<0.0001).(1) A statistically significant greater proportion of people also met the more stringent American Association of Clinical Endocrinologists (AACE) A1C target of <=6.5% (<=48 mmol/mol) with Ozempic(®) 1 mg vs placebo, both combined with an SGLT-2i, with 56.1% vs 3.9% respectively (p<0.0001).(1)

In SUSTAIN 9, the safety profile of Ozempic(®) 1 mg in combination with SGLT-2i therapy was consistent with the overall SUSTAIN program. The most common adverse event (AE) for Ozempic(®) 1 mg was nausea. Gastrointestinal AEs were reported in 37.3% and 13.2% of people treated with Ozempic(®) 1 mg and placebo, respectively. Serious AEs occurred in 4.7% and 4.0% of people, respectively. Severe or blood glucose-confirmed hypoglycemic events were reported in 4 people treated with Ozempic(®) 1 mg (2.7%) vs 0 people with placebo.(1)

About Ozempic(®
)Ozempic(®) (semaglutide) injection 0.5 mg or 1 mg is a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.(2) Ozempic(®) was approved by the U.S. Food and Drug Administration on December 5, 2017, by Health Canada on January 4, 2018, by the European Commission on February 9, 2018, by the Japanese Ministry of Health, Labour and Welfare on March 23, by Swissmedic on July 2, 2018, and by the Brazilian National Health Surveillance Agency on August 6, 2018.(3-8)

About SUSTAIN 9
SUSTAIN 9 is a double-blind, randomized, parallel-group Phase 3b trial, which included 302 adults with type 2 diabetes, conducted across six countries. Adults with type 2 diabetes and A1C 7.0-10.0% treated with a stable dose (>=90 days' treatment) of an SGLT-2 inhibitor, either as monotherapy or in combination with either metformin (71.5%) or sulfonylurea (12.9%), were randomized 1:1 to receive once-weekly Ozempic(®) (semaglutide) injection 1 mg, or a volume-matched placebo for 30 weeks. The primary endpoint was changed in A1C from baseline at Week 30. The primary and confirmatory analysis were based on Multiple Imputation (MI) followed by ANCOVA.

About the SUSTAIN clinical trial program
The SUSTAIN clinical development program 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 program involves more than 8,700 adults with type 2 diabetes in total (includes people from SUSTAIN 1-7 and 9).

What is Ozempic(®)?
Ozempic(®) (semaglutide) injection 0.5 mg or 1 mg is an injectable prescription medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.

    --  Ozempic(®) is not recommended as the first choice of medicine for
        treating diabetes. It is not known if Ozempic(® )can be used in people
        who have had pancreatitis.
    --  Ozempic(®) is not a substitute for insulin and is not for use in people
        with type 1 diabetes or people with diabetic ketoacidosis.
    --  It is not known if Ozempic(®) is safe and effective for use in children
        under 18 years of age.

Important Safety Information

Do not share your Ozempic(®) pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

What is the most important information I should know about Ozempic(®)?
Ozempic(®) may cause serious side effects, including:

    --  Possible thyroid tumors, including cancer. Tell your health care
        provider if you get a lump or swelling in your neck, hoarseness, trouble
        swallowing, or shortness of breath. These may be symptoms of thyroid
        cancer. In studies with rodents, Ozempic(®) and medicines that work
        like Ozempic(®) caused thyroid tumors, including thyroid cancer. It is
        not known if Ozempic(®) will cause thyroid tumors or a type of thyroid
        cancer called medullary thyroid carcinoma (MTC) in people.
    --  Do not use Ozempic(®) if you or any of your family have ever had MTC,
        or if you have an endocrine system condition called Multiple Endocrine
        Neoplasia syndrome type 2 (MEN 2).

Do not use Ozempic(®) if: 

    --  you or any of your family have ever had MTC or if you have MEN 2.
    --  you are allergic to semaglutide or any of the ingredients in
        Ozempic(®).

Before using Ozempic(®), tell your health care provider if you have any other medical conditions, including if you:

    --  have or have had problems with your pancreas or kidneys.
    --  have a history of diabetic retinopathy.
    --  are pregnant or breastfeeding or plan to become pregnant or breastfeed.
        It is not known if Ozempic(®) will harm your unborn baby or passes into
        your breast milk. You should stop using Ozempic(®) 2 months before you
        plan to become pregnant.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

What are the possible side effects of Ozempic(®)?
Ozempic(®) may cause serious side effects, including:

    --  inflammation of your pancreas (pancreatitis). Stop using Ozempic(®) and
        call your health care provider right away if you have severe pain in
        your stomach area (abdomen) that will not go away, with or without
        vomiting. You may feel the pain from your abdomen to your back.
    --  changes in vision. Tell your health care provider if you have changes in
        vision during treatment with Ozempic(®).
    --  low blood sugar (hypoglycemia). Your risk for getting low blood sugar
        may be higher if you use Ozempic(® )with another medicine that can
        cause low blood sugar, such as a sulfonylurea or insulin. Signs and
        symptoms of low blood sugar may include: dizziness or lightheadedness,
        blurred vision, anxiety, irritability or mood changes, sweating, slurred
        speech, hunger, confusion or drowsiness, shakiness, weakness, headache,
        fast heartbeat, and feeling jittery.
    --  kidney problems (kidney failure). In people who have kidney problems,
        diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration),
        which may cause kidney problems to get worse. It is important for you to
        drink fluids to help reduce your chance of dehydration.
    --  serious allergic reactions. Stop using Ozempic(®) and get medical help
        right away if you have any symptoms of a serious allergic reaction,
        including itching, rash, or difficulty breathing.

The most common side effects of Ozempic(®) may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.

Please see Medication Guide and Prescribing Information, including Boxed Warning for Ozempic(®), at http://www.novo-pi.com/ozempic.pdf.

About Novo Nordisk
Novo Nordisk is a global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, haemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in four states, Novo Nordisk employs approximately 5,000 people throughout the country. For more information, visit novonordisk.us, Facebook and Twitter.

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 & Endocrinology (2019). doi:
       10.1016/s2213-8587(19)30066-x.
    2. Novo Nordisk. Ozempic(®) US Prescribing Information. Available at:
       http://www.novo-pi.com/ozempic.pdf. Last accessed: March 2019.
    3. Novo Nordisk. Ozempic(®) 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: March 2019.
    4. 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%20press%20release_Eng_01.08.2018_FINAL.pdf. Last accessed:
       March 2019.
    5. Novo Nordisk. Company Announcement. Ozempic(®) (semaglutide) approved in
       the US. Available at:
       https://www.novonordisk.com/content/Denmark/HQ/www-novonordisk-com/en_gb/
       home/media/news-details.2154210.html. Last accessed: March 2019.
    6. Novo Nordisk. Ozempic(®) (semaglutide) recommended for approval by the
       European regulatory authorities. Available at:
       https://www.novonordisk.com/content/Denmark/HQ/www-novonordisk-com/en_gb/
       home/media/news-details.2156392.html. Last accessed: March 2019.
    7. Ozempic(®) (semaglutide) Brazil letter of marketing authorisation.
       August 2018.
    8. Swissmedic. Ozempic(®) (semaglutide) approval. July 2018. Available at:
       https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisat
       ions/authorised-medicinal-products-with-new-active-substances/semaglutidu
       m.html. Last accessed: March 2019.

Ozempic(®) is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
All other trademarks, registered or unregistered, are the property of their respective owners

© 2019 Novo Nordisk All rights reserved. US19OZM00107 March 2019

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SOURCE Novo Nordisk