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 78th 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.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 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.
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:
Do not use Ozempic® if:
Before using Ozempic®, tell your health care provider if you have any other medical conditions, including if you:
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:
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:
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