Rybelsus® was more effective in achieving clinically relevant blood sugar and weight reductions in people with type 2 diabetes vs all active comparators

Bagsværd, Denmark, 13 June 2020 ­– Novo Nordisk today announced results from a responder analysis of the PIONEER 1–5 and 8 trials, which showed that Rybelsus^® (oral semaglutide 14 mg) was more effective in achieving a blood sugar reduction of greater than or equal to 1% together with body weight reduction of greater than or equal to 5% compared to sitagliptin, empagliflozin and liraglutide in people with type 2 diabetes (p<0.0001).¹ The results were presented during the American Diabetes Association 80th Scientific Sessions.¹

The composite endpoint of blood sugar reductions of greater than or equal to 1% and body weight loss of greater than or equal to 5% was achieved by 27–41% of people treated with Rybelsus^® 14 mg compared with 11% of people treated with sitagliptin 100 mg; 18% with liraglutide 1.8 mg; 20% with empagliflozin 25 mg and 1–8% with placebo.¹

Additionally, across the trials, any reduction in blood sugar was seen in higher proportions of people treated with Rybelsus^® (89–95%) than those treated with active comparators (82–88%) or with placebo (51–64%). Any reduction in blood sugar and body weight was seen in 72–86% of people treated with Rybelsus^®.¹

“Controlling blood sugar levels and managing weight are challenges faced by many people living with type 2 diabetes, which can have serious consequences for long-term health,” said Associate Professor Kathleen Dungan, study investigator, The Ohio State University, Columbus, US. “The results of this responder analysis indicate that oral semaglutide has the potential to help more people with type 2 diabetes achieve clinically relevant blood sugar and weight goals compared with other commonly used oral antidiabetic medicines.”

In 2019, an estimated 463 million people worldwide were living with diabetes, 90% of whom were living with type 2 diabetes.² Despite the availability of many treatment options for type 2 diabetes, more than half of people living with the condition do not achieve target blood sugar levels,³ pointing to the need for efficacious treatment options.

“This analysis reinforces the strong clinical profile of Rybelsus^® demonstrated in the phase 3a clinical trial programme,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Based on this growing evidence base, combined with its oral formulation, we believe Rybelsus^® has the potential to set a new standard for the treatment of type 2 diabetes.”

For more news and media materials from Novo Nordisk at ADA 2020, please visit https://www.epresspack.net/novonordiskADA2020/post-hoc-analysis-pioneer/

About Rybelsus^®

Rybelsus^® (oral semaglutide), an analogue of the naturally occurring hormone glucagon-like peptide-1 (GLP-1), is the first and only GLP-1 receptor agonist in a pill. In the EU, Rybelsus^® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycaemic control as an adjunct to diet and exercise. It is administered once daily and is approved for use in two therapeutic dosages, 7 mg and 14 mg.⁴

About PIONEER clinical trial programme

PIONEER (Peptide Innovation for Early Diabetes Treatment) is the global phase 3a clinical trial programme that investigated Rybelsus^® for the treatment of type 2 diabetes. The clinical trial programme involved 9,543 people with type 2 diabetes across 10 clinical trials. The programme evaluated the safety and efficacy of Rybelsus^® in people with type 2 diabetes vs other glucose-lowering therapies for type 2 diabetes, including SGLT-2i, DPP-4i, GLP-1 receptor agonists and as an add-on to insulin.^5-14

About Novo Nordisk

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 43,100 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

Further information

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References

1.         Dungan K, Hertz CL, Mellbin L, et al. Glycemic and Body Weight Responses to Oral Semaglutide in the PIONEER Trial Program. Abstract 964-P. Presented during the 80th Scientific Sessions of the American Diabetes Association, General Poster Session 2, 13:00 CDT on 13 June 2020.

2.         International Diabetes Federation. IDF Diabetes Atlas 9th edition, 2019. Available at: https://www.diabetesatlas.org/en/resources/ Last accessed: June 2020.

3.         Raccah D, Chou E, Colagiuri S, et al. A global study of the unmet need for glycemic control and predictor factors among patients with type 2 diabetes mellitus who have achieved optimal fasting plasma glucose control on basal insulin. Diabetes Metab Res Rev. 2017;33.

4.         EMA. Rybelsus^® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rybelsus. Last accessed: June 2020.

5.         Aroda VR, Rosenstock J, Terauchi Y, et al. PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes. Diabetes Care. 2019;42:1724-1732.

6.         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;42:2272-2281.

7.         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;321:1466-1480.

8.         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;394:39-50.

9.         Mosenzon O, Blicher TM, 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 Endocrinol. 2019;7:515-527.

10.       Husain M, Birkenfeld AL, Donsmark M, et al. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2019;381:841-851.

11.       Pieber TR, Bode B, Mertens A, et al. Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial. Lancet Diabetes Endocrinol. 2019;7:528-539.

12.       Zinman B, Aroda VR, Buse JB, et al. Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. Diabetes Care. 2019;42:2262-2271.

13.       Yamada Y, Katagiri H, Hamamoto Y, et al. Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes (PIONEER 9): a 52-week, phase 2/3a, randomised, controlled trial. The Lancet Diabetes & Endocrinology. 2020;8:377-391.

14.       Yabe D, Nakamura J, Kaneto H, et al. Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial. The Lancet Diabetes & Endocrinology. 2020;8:392-406.