NOVO NORDISK
Sat, 26 Jun 2021 16:30:00 -0400
Sat, 26 Jun 2021 16:30:00 -0400
PLAINSBORO, N.J., June 26, 2021 /PRNewswire/ -- Novo Nordisk today presented data showing that an investigational 2 mg dose of Ozempic® (semaglutide) injection provided statistically significant and superior reductions in blood sugar (A1C) compared with Ozempic® 1 mg.1 These data were the outcome of the SUSTAIN FORTE trial, a phase 3b, 40-week, efficacy and safety trial comparing once-weekly semaglutide 2 mg vs Ozempic® 1 mg as an add-on to metformin with or without sulfonylureas in 961 adults with type 2 diabetes in need of additional blood sugar reduction. The results were presented at the 81st Annual Scientific Sessions of the American Diabetes Association (ADA)1,2 and the primary results are in press for publication in The Lancet Diabetes & Endocrinology.
The trial met its primary endpoint, where people treated with once-weekly semaglutide 2 mg with an elevated mean baseline A1C of 8.9% demonstrated a statistically significant and superior 2.2% reduction in A1C compared with a reduction of 1.9% seen with Ozempic® 1 mg after 40 weeks, when taken as intended.1*
Further post hoc subgroup analyses, presented at the congress, showed that semaglutide 2 mg demonstrated greater reductions in blood sugar at 40 weeks compared with Ozempic® 1 mg, across baseline A1C subgroups (Table 1).2
"Some people living with type 2 diabetes require additional support to reach their blood glucose targets," said Dr. Juan Pablo Frias, medical director of the National Research Institute, Los Angeles and principal investigator of SUSTAIN FORTE. "The reductions in blood glucose seen with semaglutide 2 mg demonstrate that a higher dose of Ozempic® may offer individuals the opportunity to further improve their diabetes control, with comparable tolerability to Ozempic® 1 mg."
From a mean baseline body weight of 99.3 kg, semaglutide 2 mg demonstrated a statistically significant weight reduction of 6.9 kg compared with 6.0 kg with Ozempic® 1 mg.† Based on the treatment policy estimand, people treated with semaglutide 2 mg experienced a statistically non-significant weight reduction of 6.4 kg compared with 5.6 kg with Ozempic® 1 mg. Further post hoc analyses presented across baseline BMI subgroups showed greater non-significant reductions in body weight with semaglutide 2 mg compared with the 1 mg dose (Table 1).2
The incidence of adverse events (AEs) was similar for both doses in the primary analysis and included gastrointestinal events (nausea, diarrhea, and vomiting). Gastrointestinal events are the most common AEs associated with GLP-1 RAs, including Ozempic®.
"Ozempic® has helped millions of people with type 2 diabetes worldwide lower their blood sugar, and although not indicated for weight loss, has demonstrated weight reduction for some patients. It has also helped reduce their risk of major cardiovascular events in adults with type 2 diabetes with established cardiovascular disease," said Martin Lange, executive vice president of Novo Nordisk. "For almost a century, our mission has been to drive change in diabetes treatment and innovation to improve the lives of people living with diabetes. These data show us that with a higher 2 mg dose of semaglutide, we can help even more adults living with type 2 diabetes, who are not at glycemic control, lower their A1C."
Post hoc Subgroup Analysis of
Primary Change in A1C2 |
Post hoc Subgroup Analysis of
Secondary Change in body weight2 | |||||||
Baseline | A1C <9.0% | A1C ≥9.0% | BMI <35 |
BMI | A1C <9.0% | A1C ≥9.0% |
BMI |
BMI |
Semaglutide 2 mg | -1.9% | -2.6% | -2.2% | -2.1% | -7.4 kg | -6.3 kg | -6.6 kg | -7.4 kg |
Ozempic® 1 mg | -1.7% | -2.3% | -1.9% | -2.0% | -6.2 kg | -5.8 kg | -5.2 kg | -7.1 kg |
Table 1. Post hoc subgroup analysis showing change in mean A1C and body weight stratified from baseline to Week 40.‡ |
On the basis of the primary results, Novo Nordisk previously announced the submission of a label extension application to the European Medicines Agency (EMA) in December 2020, and to the US Food and Drug Administration (FDA) in May 2021, to evaluate an additional higher dose of 2 mg Ozempic® for adults with type 2 diabetes.
What is Ozempic®?
Ozempic®
(semaglutide) injection 0.5 mg or 1 mg is an injectable prescription
medicine used:
It is not known if Ozempic® can be used in people who have
had pancreatitis.
Ozempic® is not for use in people
with type 1 diabetes.
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:
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 Ozempic
®
Ozempic® (semaglutide) injection 0.5 mg or 1 mg is a
once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist
indicated along with diet and exercise to improve blood sugar
(glucose) in adults with type 2 diabetes mellitus and to reduce the
risk of major cardiovascular events such as heart attack, stroke, or
death in adults with type 2 diabetes mellitus with known heart disease.3,4
About the SUSTAIN clinical program
The SUSTAIN clinical development program for once-weekly
subcutaneous semaglutide injection currently comprises 11 phase 3
global clinical trials, including a cardiovascular outcomes trial,
involving more than 11,000 adults with type 2 diabetes in total.
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, hemophilia 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
six states, Novo Nordisk employs nearly 6,000 people throughout the
country. For more information, visit
novonordisk.us
,
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Twitter
.
_______________________
References
Ozempic® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk
A/S.
© 2021 Novo Nordisk All rights reserved.
US21OZM00497 June 2021
* Based on the trial product estimand: treatment effect if all people adhered to treatment and did not initiate other type 2 diabetes therapies. When applying the treatment policy estimand, which is the treatment effect regardless of treatment adherence or initiation of other type 2 diabetes therapies, people treated with semaglutide 2 mg experienced a reduction in A1C of 2.1% compared to 1.9% for people treated with the 1 mg dose at Week 40.
† Treatment effect if all people adhered to treatment and did not initiate other type 2 diabetes therapies.
‡ Treatment-by-treatment subgroup interactions were non-significant. Data are estimated mean values and represent all randomized participants who had not discontinued treatment or initiated additional antidiabetes medications.
SOURCE Novo Nordisk