Investigational 2 mg Dose of Ozempic® (semaglutide) Injection Demonstrates Superior Reductions in Blood Sugar vs Ozempic® 1 mg in Adults With Type 2 Diabetes in a Phase 3 Trial

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Jun 26, 2021, 16:30 ET

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 81^st Annual Scientific Sessions of the American Diabetes Association (ADA)^1,2and 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 Endpoint Change in A1C²				Post hoc Subgroup Analysis of Secondary Endpoint Change in body weight²
Baseline	A1C <9.0%	A1C ≥9.0%	BMI <35	BMI ≥35	A1C <9.0%	A1C ≥9.0%	BMI <35	BMI ≥35
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:

along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus.
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.

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:

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^®. See symptoms of serious allergic reaction in "What are the possible side effects of 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 swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.

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, Facebook, Instagram and Twitter.

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References

Frias J, Auerbach P, Bajaj H, et al. Efficacy and Safety of Once-Weekly Semaglutide 2.0 vs 1.0 mg for Type 2 Diabetes: SUSTAIN FORTE Randomized Trial. Presented during the 81st Scientific Sessions of the American Diabetes Association: Oral 101-OR.
Frias J, Auerbach P, Bajaj H, et al. Efficacy and Safety of Once-Weekly Semaglutide 2.0 vs 1.0 mg by Baseline HBA_1c and BMI: SUSTAIN FORTE Subgroup Analyses. Presented during the 81st Scientific Sessions of the American Diabetes Association: ePoster 665-P.
EMA. Ozempic^® (once-weekly semaglutide) Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004174/WC500244163.pdf. Last accessed: June 2021.
FDA. Ozempic^® (once-weekly semaglutide) US Prescribing Information. Available at: https://www.novo-pi.com/ozempic.pdf. Last accessed: May 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