Novo Nordisk launches once-weekly Ozempic® for the treatment of type 2 diabetes in South Africa

Ozempic® (once-weekly semaglutide), Novo Nordisk’s latest innovation in diabetes management, provides superior and clinically meaningful reductions in blood glucose and body weight, in addition to proven cardiovascular benefits in people living with type 2 diabetes1-5

21 August 2021 – Novo Nordisk today announced that Ozempic® (once-weekly semaglutide), a treatment for type 2 diabetes, is now available in South Africa. Alongside diet and exercise, Ozempic® is a once weekly GLP-1 indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.6

 

“I see many Type 2 diabetic patients in my clinic weekly, many of them are not controlled. The reasons range from underestimating the severity of their condition, to patients remaining on their initial diabetes medication for too long which leads to complications. These complications can be life threatening and permanent.” said Dr Bayat Endocrinologist.

Approval of Ozempic® in South Africa is based on results from the SUSTAIN clinical Programme, a global clinical development programme comprising 10 Phase 3 trials, including more than 10 000 adults with type 2 diabetes. Results from the trials consistently demonstrated superior reductions in blood sugar and body weight versus all comparators.1-4,7-9 Up to 80% of people treated with Ozempic® achieved the American Diabetes Association (ADA) treatment target of HbA1c below 7.0%.1-4,7-9

 

In a two-year cardiovascular outcomes trial, once-weekly Ozempic® reduced cardiovascular risk by 26% versus placebo, when added to standard of care in subjects with high cardiovascular risk.5

“We are proud that Ozempic® is now available to treat type 2 diabetes in South Africa as it reiterates Novo Nordisk’s commitment to bring life-saving treatment to patients” said Mr Venkat Kalyan, Vice President and GM of Novo Nordisk South Africa.

 

“Ozempic® is the only once-weekly anti-diabetic treatment that unifies superior efficacy and cardiovascular benefits; and we believe the clinical profile of Ozempic® may help in meeting the real and serious needs of those living with this condition. When type 2 diabetes is well managed, the risk of life-limiting and potentially fatal complications can be reduced.” Kalyan concluded.

 

About Ozempic®

Ozempic® (once-weekly semaglutide) is a new analogue of human glucagon-like peptide 1 (GLP-1) that has been developed for the treatment of type 2 diabetes. Ozempic® stimulates insulin and supresses glucagon secretion in a glucose-dependent manner, while decreasing appetite and food intake.10-13 It also reduces cardiovascular risk by modifying the progression of atherosclerosis (the build-up of fatty deposits in the arteries), as well as by reducing blood pressure, lipid levels and weight.5,14,15

Across the SUSTAIN clinical trial programme, Ozempic® was shown to be safe and well tolerated.1-5,7,8 The most frequently reported adverse reactions were gastrointestinal disorders, including nausea, diarrhoea and vomiting. 1-5,7,8 In general, these reactions were mild or moderate in severity and transient in nature. 1-5,7,8

 

For information about Ozempic®, including important safety information, please contact Novo Nordisk’s medical department.

For full prescribing information, refer to the Professional Information approved by the Regulatory Authority.

 

About the SUSTAIN clinical development programme

SUSTAIN is a global clinical development programme for Ozempic® that comprised 10 phase 3 trials, encompassing more than 10 000 adults with type 2 diabetes. The programme involved a broad range of people with type 2 diabetes, including some with high cardiovascular risk profiles and people with and without renal disease.1-5,7-9,16,17

 

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 45,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn and YouTube.

 

References
  1. Ahrén B, Masmiquel L, Kumar H, et al. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): A 56-week, double-blind, phase 3a, randomised trial. Lancet Diabetes Endocrinol. 2017;5:341-54.
  2. Ahmann AJ, Capehorn M, Charpentier G, et al. Efficacy and safety of once-weekly semaglutide versus exenatide er in subjects with type 2 diabetes (SUSTAIN 3): A 56-week, open-label, randomized clinical trial. Diabetes Care. 2018;41:258-66.
  3. Aroda VR, Bain SC, Cariou B, et al. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): A randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet Diabetes Endocrinol. 2017;5:355-66.
  4. Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide once weekly versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6(4):275-86.
  5. Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375:1834-44.
  6. Ozempic® South Africa PI.
  7. Sorli C, Harashima SI, Tsoukas GM, et al. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol. 2017;5:251-60.
  8. Rodbard HW, Lingvay I, Reed J, et al. Semaglutide added to basal insulin in type 2 diabetes(SUSTAIN 5): a randomised, controlled trial. The Journal of Clinical Endocrinology & Metabolism. ePub ahead of print. https://doi.org/10.1210/jc.2018-00070. 2018.
  9. Capehorn M, Janez A, Price H, et al. Efficacy and safety of semaglutide 1.0mg once weekly vs liraglutide 1.2mg once daily as add‐on to 1–3 oral antidiabetic drugs in subjects with Type 2 diabetes (SUSTAIN 10). Abstract presented at the Diabetes UK Conference 2019, Liverpool.
  10. Korsatko A, Brunner M, Sach-Friedl S, et al. Effect of once-weekly semaglutide on the counter-regulatory response to hypoglycaemia in subjects with type 2 diabetes. Abstract 764. 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD), Munich, Germany; 12–16 September 2016.
  11. Kapitza C, Dahl K, Jacobsen JB, et al. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017;60:1390-99.
  12. Blundell J, Finlayson G, Axelsen M, et al. Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity. Diabetes Obes Metab. 2017;19:1242-51.
  13. Hjerpsted JB, Flint A, Brooks A, et al. Semaglutide improves postprandial glucose and lipid metabolism, and delays first-hour gastric emptying in subjects with obesity. Diabetes Obes Metab. 2018;20:610-19.
  14. Drucker DJ. The cardiovascular biology of glucagon-like peptide-1. Cell Metabolism.2016;24(1):15-30.
  15. Rakipovski G, Rolin B, Kirk R, et al. Long acting GLP-1 receptor agonists, semaglutide and liraglutide protect against development of atherosclerosis in animal models independent of body weight lowering effects. Presented at the 77th Scientific Sessions of the American Diabetes Association, 9-13 June 2017, San Diego, USA: Oral 244- OR.
  16. Seino Y, Terauchi Y, Osonoi T, et al. Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes. Diabetes Obes Metab. 2018;20:378-88.
  17. Kaku K, Yamada Y, Watada H, et al. Safety and efficacy of once-weekly semaglutide versus additional oral antidiabetic drugs, in Japanese subjects with inadequately controlled T2D: a randomised trial. Diabetes Obes Metab. 2018;20(5):1202-12.