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In the Phase 3 programme, acute pancreatitis confirmed by adjudication was reported in RYBELSUS® (<0.1%) and comparator (0.2%). Acute pancreatitis has been observed with the use of GLP-1 RAs. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, RYBELSUS® should be discontinued.1

In patients with diabetic retinopathy treated with insulin and Ozempic® (s.c. semaglutide), an increased risk of developing diabetic retinopathy complications has been observed, a risk that cannot be excluded for RYBELSUS®. Caution should be exercised when using semaglutide in patients with diabetic retinopathy. These patients should be monitored closely and treated according to clinical guidelines.1

RYBELSUS - The only type 2 diabetes pill of its kind

RYBELSUS® delivers HbA1c reduction with added benefit of weight loss, helping your patients reduce the risk of long-term complications associated with type 2 diabetes.
PIONEER clinical trials

Find out more about the Phase 3 clinical trial programme investigating RYBELSUS® (oral semaglutide).

 

 

How RYBELSUS ® works

By combining semaglutide with the SNAC absorption enhancer, we found a way to deliver a GLP-1 RA in a tablet.

 

 

1.

RYBELSUS® [summary of product characteristics]. Bagsværd, Denmark: Novo Nordisk A/ S; April 2023.

2.

CKD Work Group. Kidney Disease: Improving Global Outcomes (KDIGO). 2012 Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease. Kidney Inter. 2013;3(suppl):1-150.

3.

Bækdal TA, Thomsen M, Kupcova V, Hansen CW, Anderson TW. Pharmacokinetics, safety, and tolerability of oral semaglutide in subjects with hepatic impairment.) Clin Pharm. 2018;58(10):1314-1323.

4.

Mosenzon O, Blicher TM, Signe Rosenlund S, et al. Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial. Lancet Diabetes Endocinol. 2019;7(7):515-527.

5.

Husain M, Birkenfeld AL, Donsmark M, et al. Oral semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2019;381(9):841-851.

6.

Data on file. PIONEER 1 data. Novo Nordisk A/S Bagsværd, Denmark.

7.

Rasalam R, Barlow J, Kennedy M, et al. GLP-1 Receptor Agonists for Type 2 Diabetes and Their Role in Primary Care: An Australian Perspective. Diabetes Ther. 2019;10(4):1205–1217.

8.

Cornell S. A review of GLP-1 receptor agonists in type 2 diabetes: a focus on the mechanism of action of once-weekly agents. Journal of Clinical Pharmacy and Therapeutics. 2020;45(51):17-27.

9.

Rosenstock J, Allison D, Birkenfeld AL, et al. Effect of additional oral semaglutide vs sitagliptin on glycated hemoglobin in adults with type 2 diabetes uncontrolled with metformin alone or with sulfonylurea: the PIONEER 3 randomized clinical trial.JAMA. 2019;42(12):2272-2281.

10.

Rodbard HW, Rosenstock J, Canani LH, et al. Oral semaglutide versus empagliflozin in patients with type 2 diabetes uncontrolled on metformin: the PIONEER 2 trial. Diabetes Care. 2019;42(12):2272-2281.

11.

Pratley R, Amod A, Hoff ST, et al. Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. Lancet. 2019;394(10192):39-50.

12.

Data on file. IQVIA Midas December 2020, IQVIA Disease Analyser Germany December 2020, LAAD USA November 2020.

13.

Davies MJ, D'Alessio DA, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;41 (12):2669-2701.

14.

American Diabetes Association. 1. Improving Care and Promoting Health in Populations: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021;44:S7–S14.

15.

Cosentino F, Grant PJ, Aboyans V, et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J 2020;41:255–323.

16.

Data on file. MAT volume data. IMS Mtn. November 2021.

17.

Data on file. Novo Nordisk A/S Bagsværd, Denmark. 2016-2021.