NOVO NORDISK

Press release

Wed, 16 Jun 2021 09:07:00 -0400

Novo Nordisk to present research across diabetes and obesity portfolio at the 81st Annual American Diabetes Association Scientific Sessions

New data to be shared, including results from SUSTAIN FORTE phase 3 trial studying the efficacy and safety of investigational 2 mg dose of Ozempic® (semaglutide) injection for the treatment of type 2 diabetes

PLAINSBORO, N.J., June 16, 2021 /PRNewswire/ -- Novo Nordisk announced that new data from more than 30 abstracts will be presented from the company's approved and investigational medicines highlighting its broad diabetes and obesity portfolio at the upcoming 81^st Annual Scientific Sessions of the American Diabetes Association (ADA). The meeting will be held virtually from June 25-29, 2021.

"The range of data that we are proud to share at this scientific exchange reflects the tremendous unmet need that still exists, and the need to better understand the links between obesity, diabetes and cardiovascular disease," said Doug Langa, executive vice president, North America operations and president of Novo Nordisk Inc. "We continue to leverage our nearly 100 years of dedication to research and innovation to lead in the area of cardiometabolic diseases and bring forth relevant clinical data that supports better medicines and better treatment for patients."

New data will be presented across our diabetes and obesity portfolio, including results from the SUSTAIN FORTE phase 3 clinical trial evaluating an investigational 2 mg dose of Ozempic^® (semaglutide) injection in adults with type 2 diabetes.

Diabetes
Ozempic^® (semaglutide) injection

Efficacy and safety of once-weekly semaglutide 2 vs 1 mg for type 2 diabetes: SUSTAIN FORTE randomized trial (Oral 101-OR)
Efficacy and safety of once-weekly semaglutide 2 vs 1 mg by baseline HbA1c and BMI: SUSTAIN FORTE subgroup analyses (ePoster 665-P)
Mobile health application as a real-world data resource – self-recorded weight reduction with once-weekly semaglutide (ePoster 645-P)

Rybelsus^® (semaglutide) tablets

Achievement of near-normal HbA1c with early initiation of oral semaglutide: an exploratory subgroup analysis of PIONEER 1 (ePoster 663-P)
Time spent in glycemic control after initiating treatment with oral semaglutide vs. empagliflozin: an exploratory analysis of the PIONEER 2 trial (ePoster 670-P)

Insulins

Similar hypoglycemia duration with once-weekly insulin icodec vs once daily insulin glargine U100 in insulin naïve or experienced patients with T2D (Oral 191-OR)
CGM-based measurements for once-weekly insulin icodec vs once-daily insulin glargine U100 in insulin-treated patients with T2D: a post-hoc analysis (ePoster 731-P)
CGM-derived parameters for once-weekly insulin icodec vs once-daily insulin glargine U100 in insulin-naïve patients with T2D (ePoster 732-P)
Association between Time in Range and A1C in basal insulin-treated people with type 2 diabetes (ePoster 618-P)
Association between change in Time in Range and A1C in basal insulin-treated people with type 2 diabetes (ePoster 618-P)
Higher derived Time in Range with IDegLira vs insulin glargine U100 in patients with T2D (ePoster 606-P)

Cardiovascular Care in Type 2 Diabetes

Total costs of care in patients with T2D and cardiovascular disease: a comparative cohort study (OFFSET) (ePoster 82-LB)
Cardiovascular autonomic neuropathy and risk of heart failure in participants with type 2 diabetes enrolled in DEVOTE trial (Oral 225-OR)
Associations between patient characteristics and cardiovascular disease: a post-hoc analysis from the CAPTURE study (ePoster 974-P)
Use of glucose-lowering agents according to cardiovascular risk factors in people with T2D and with or without CVD in the CAPTURE study (ePoster 990-P)

Obesity
Research will also be presented on the use of Wegovy™ (semaglutide) injection 2.4 mg, in adults with excess weight or obesity and type 2 diabetes from the STEP (Semaglutide Treatment Effect in People with Obesity) program. Wegovy™ was approved by the US Food and Drug Administration (FDA) on June 4, 2021 to treat adults with obesity (BMI≥30) or overweight (excess weight) (BMI ≥27) who also have weight-related medical problems to help them lose weight and keep the weight off. Wegovy™ should be used with a reduced calorie meal plan and increased physical activity. Select highlights include:

Once-weekly semaglutide 2.4 mg effects on glucose metabolism and prediabetes in adults with overweight/obesity in the STEP 1 trial (Oral 81-OR)
Treatment with once-weekly semaglutide 2.4 mg effects on cardiometabolic risk factors in adults with overweight/obesity and type 2 diabetes: STEP 2 post-hoc analysis (Oral 80-OR)

The above abstracts and presentations are representative of the data that will be presented or published by Novo Nordisk. This press release contains forward-looking statements about investigational products currently in development by Novo Nordisk. As is expected, there is significant risk with drug development and there is no guarantee that future studies will reflect similar results as presented at ADA. For further information about the Novo Nordisk drug pipeline, visit http://www.novonordisk.us.

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.

About Rybelsus^® Rybelsus^® (semaglutide) tablets 7 mg or 14 mg is an analog of the naturally occurring hormone GLP-1. Rybelsus^® is a prescription medicine for adults with type 2 diabetes that, along with diet and exercise, may improve blood sugar. Rybelsus^® is the first and only GLP-1 receptor agonist in a pill. It is administered once daily and is approved for use in two therapeutic doses: 7 mg and 14 mg.

About Wegovy™
Wegovy™ (semaglutide) injection 2.4 mg is an injectable prescription medicine used with a reduced calorie meal plan and increased physical activity for adults with obesity (BMI ≥30) or overweight (excess weight) (BMI ≥27) who also have weight related medical problems to help them lose weight and keep the weight off. Wegovy™ was approved by the FDA on June 4, 2021. It is currently under review in the European Union and other countries.

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.

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

SOURCE Novo Nordisk