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Semaglutide (Rybelsus®) – the first type 2 diabetes oral pill in its class (GLP-RA)

Diabetes is a global epidemic affecting around 463 million adults worldwide.1 India is considered the diabetes capital of the world. Around 69.9 million patients are expected to be suffering from Type 2 diabetes by 2025. This is projected to increase to 80 million by 2023 which is a 266% increase.2

Current treatment guidelines recommend lifestyle changes, such as diet and exercise along with pharmacotherapy. Metformin is considered as gold standard and is routinely prescribed in newly diagnosed diabetes patients. However, it is contraindicated in some patients and some patients may not able to tolerate metformin. The 2nd line oral diabetic agents include Sulfonylureas, DPP-4 inhibitors, and SGLT-2 inhibitors. Triple oral therapy or insulin may be considered in patients not reaching the target with dual therapy.3

Uncontrolled diabetes can lead to microvascular and macrovascular complications. Cardiovascular disease is the leading cause of death in diabetes patients. Uncontrolled blood glucose levels can impact vision, kidney function and may also cause peripheral neuropathy, retinopathy and nephropathy. Diabetic retinopathy is the leading cause of visual impairment and is the fifth leading cause of blindness.4

Improving diabetes control with Innovations

Modern science has been providing novel treatment options for diabetes including premix insulin, Glucagon-like peptide-1 (GLP-1), and oral antidiabetic agents. Significant research is happening in insulin injections and improving control or even providing insulin in other dosage forms. Novo Nordisk has been leading innovations in this segment, consistently contributing to advancements in diabetes treatment.5

Semaglutide, the injectable GLP1 RA

Semaglutide, the injectable GLP1RA (Ozempic) is one of the recent innovations from Novo Nordisk which has created quite a buzz among the medical fraternity.5 It acts by improving the efficiency of incretin function by activating GLP-1 receptors. Semaglutide augments insulin secretion, inhibits glucagon release, and suppresses hepatic gluconeogenesis, thereby reducing both fasting as well as postprandial glucose. Remarkably, insulin secretion is glucose-dependent, unlike other oral antidiabetic agents.6 The action is similar to the natural GLP-1 hormone released by the body after meals.7

Semaglutide is now available as a once-daily pill

Semaglutide is now available as a once-daily pill (Rybelsus®) with all the benefits offered by the injectable form. It is recommended for adults with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control. Oral Semaglutide offers superior A1C reduction compared to sitagliptin, liraglutide, and empagliflozin. Its clinical efficacy and safety is established in multiple clinical trials.8

Results from the PIONEER 4-study have shown that oral Semaglutide can significantly reduce HbA1c levels and promote weight loss in type 2 diabetes patients.9 The safety profile is also well established in multiple clinical trials. The results from the SUSTAIN-6 study showed a significant reduction in the risk of major adverse cardiovascular events (MACE) compared to placebo in type 2 diabetes patients who were at high risk for cardiovascular disease.10 

Conclusion

Rybelsus® (Oral semaglutide), developed by Novo Nordisk, is the first oral GLP-1 receptor agonist to receive FDA approval. This innovative medication offers superior efficacy, providing a dual benefit by reducing HbA1c levels and promoting weight loss. Oral Semaglutide is a convenient alternative to injectable GLP1RA. Now patients can have all the benefits of injectable GLP-1 RA in a once-daily pill.


Dosage and Administration: Rybelsus® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.  Rybelsus® is taken orally as a tablet once a day, recommended in the morning on an empty stomach. The starting dose is usually 3 mg per day, which may be increased to 7 mg or 14 mg per day depending on individual patient needs and tolerability.11


About the Author: Dr. Lokesh Naik, is a Pharm D graduate with a passion for medical research and medical writing. He has keen interest in understanding pharmacological agents, their efficacy and safety, and their benefits to patients. His current focus is on lifestyle disorders including diabetes. Click here to connect with Dr. Lokesh on Linkedin.

Editorial support was provided by Dr. Geetika Gupta. She is from dental background with experience in developing medical content for pharmaceutical clients. Click here to connect with Dr. Geetika Gupta.


References

1. Saeedi P, et al. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843.

2. Pandey SK, Sharma V. World diabetes day 2018: Battling the Emerging Epidemic of Diabetic Retinopathy. Indian J Ophthalmol. 2018 Nov;66(11):1652-1653.

3. ICMR guidelines for management of type 2 diabetes 2018- Indian council of medical research. Available at: https://main.icmr.nic.in/sites/default/files/guidelines/ICMR_GuidelinesType2diabetes2018_0.pdf .Accessed on 12 May 2023.

4. Petrie JR, Guzik TJ, Touyz RM. Diabetes, Hypertension, and Cardiovascular Disease: Clinical Insights and Vascular Mechanisms. Can J Cardiol. 2018 May;34(5):575-584.

5. Diabetes medication Novo Nordisk. Available at https://www.novonordisk.com/our-products/our-medicines.html  Accessed on 23 May 2023.

6. Mahapatra MK, Karuppasamy M, Sahoo BM. Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes. Rev Endocr Metab Disord. 2022 Jun;23(3):521-539.

7. Rybelsus®  (semaglutide tablets), the world’s first and only oral GLP-1 RA, now available in the UK to treat type 2 diabetes. Available at: https://www.novonordisk.co.uk/content/dam/nncorp/gb/en/pdfs/media-and-news/Medical_trade_media_press_release_Rybelsus_now_available_in_the_UK_for_T2D.pdf Accessed on : 23 May 2023

8. Rybelsus results. Available at: https://www.rybelsus.com/why-rybelsus/rybelsus-results.html Accessed on 23 May 2023.

9. Hughes S, Neumiller JJ. Oral Semaglutide. Clin Diabetes. 2020 Jan;38(1):109-111.

10. Husain M, et al. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. 

11. Rybelsus - FDA. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213051s000lbl.pdf Accessed on 23 May 2023.


Disclaimer: The matter published in this blog has been developed by independent medical writers from various healthcare backgrounds including members from MedWriters Alumni Network. It has been validated by the experts' panel of Crixus. Although great care has been taken in compiling and checking the information, the authors, Crixus Communications Pvt Ltd and its servants or agents, and sponsors shall not be responsible or in any way liable for any errors, omissions, or inaccuracies in this blog article whether arising from negligence or otherwise, however or for any consequences arising therefrom. The inclusion and exclusion of any product do not mention that the publisher advocates or rejects its use generally or in any particular field or field. For any complaints or feedback please write to [email protected]