Ozempic® provided greater weight reductions for adults with a baseline BMI ≥25kg/m2 than those with lower baseline BMI <25kg/m2, in a SUSTAIN 7 post-hoc analysis

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Jun 23, 2018, 10:09 ET

ORLANDO, Fla., June 23, 2018 /PRNewswire/ -- Ozempic^® (semaglutide) injection 0.5 mg or 1 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 A1C, this post-hoc exploratory analysis examined the secondary endpoint of change in body weight by baseline BMI.¹ The results will be presented on June 24, 2018 at the American Diabetes Association's 78^th Scientific Sessions (ADA) in Orlando, Fla.

Greater weight reductions were demonstrated across all BMI subgroups (<25, 25–<30, 30–<35, ≥35 kg/m²) with Ozempic^®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^® 1 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^® generally achieved greater weight reductions than those with lower baseline BMI (<25 kg/m²).

In addition, more people achieved weight reduction of ≥5% and ≥10% with Ozempic^® vs dulaglutide in all BMI subgroups.

"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^® can help people living with type 2 diabetes manage their A1C 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^® 0.5 and 1 mg, and dulaglutide 1.5 mg). The most common adverse events (≥5%) for both Ozempic^® dosages were GI adverse events.

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 glycaemic control in adults with type 2 diabetes.³ 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 and on March 23 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^® 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 in January 2018. The primary outcome measure was change in A1C from baseline after 40 weeks of treatment. Change in body weight from baseline to week 40 was a predefined secondary endpoint.⁷In 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 mg vs dulaglutide 1.5 mg: p= 0.8175).

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, a global healthcare company, has been committed to discovering and developing innovative medicines to help people living 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, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for 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 nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook and Twitter.

References:

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.
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: June 2018.
Novo Nordisk. Ozempic^®Prescribing Information. Available at: http://www.novo-pi.com/ozempic.pdf. Last accessed: June 2018.
Novo Nordisk. Ozempic^® Canada Product Monograph. Available at https://pdf.hres.ca/dpd_pm/00043163.PDF. Last accessed: June 2018.
EMA. Ozempic^®(semaglutide) SmPC. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR Product_Information/human/004174/WC500244163.pdf. Last accessed: June 2018.
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: June 2018.
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.

Ozempic^® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
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