Rybelsus (semaglutide), 7 mg, 10 tablets: profile, composition and research

Reference page for Rybelsus (semaglutide), 7 mg, 10 tablets. Active substance: Семаглутид / Semaglutide.

Key facts

What oral semaglutide is

Rybelsus is the oral trade form of semaglutide. Semaglutide belongs to the GLP-1 receptor agonists: it reproduces the action of a hormone produced in the gut after a meal.

Medicines of this group are usually given by injection, because peptides are broken down in the stomach. The oral form became possible thanks to the auxiliary component SNAC, which helps semaglutide to be absorbed through the stomach lining.

The medicine is supplied as 7 mg tablets, 10 tablets per pack. It is a prescription product used in type 2 diabetes as part of a wider treatment plan.

How semaglutide acts

The GLP-1 receptor

Semaglutide binds to glucagon-like peptide-1 receptors and activates them. This raises insulin production at times when the blood glucose level is high.

Lower glucagon

At the same time the medicine reduces the secretion of glucagon, a hormone that raises the sugar level. The combined action of these mechanisms helps to smooth out glucose fluctuations.

Stomach and appetite

Semaglutide slows gastric emptying and affects the feeling of fullness, which is reflected in appetite. The possible gastrointestinal reactions are linked to the same effect.

Approved uses

The prescribing information names type 2 diabetes in adults as an addition to diet and physical activity, for better control of the glucose level.

A feature of the oral form is that it requires particular conditions of intake: the tablet is swallowed whole on an empty stomach with a small amount of water and a pause is kept before eating. This follows from the way it is absorbed rather than from personal choice.

The particular dose and its changes are set by a physician. The medicine is not used in type 1 diabetes or in diabetic ketoacidosis; it does not replace insulin where insulin is needed.

What the research shows

Oral semaglutide was studied in the PIONEER programme of clinical trials. In the PIONEER 1 study the medicine as monotherapy was compared with placebo in patients with type 2 diabetes.

In PIONEER 3 the addition of oral semaglutide and of sitagliptin was compared in patients whose glucose control was insufficient on metformin. In PIONEER PLUS higher doses of the medicine were assessed.

Separate reviews describe the role of SNAC in creating the oral form of a peptide medicine. The data come from controlled studies, but the decision about use and dose remains with a physician; links to the primary sources are given below.

Published research

Primary sources, verified against PubMed:

• PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes., PubMed 31186300 (Diabetes care, 2019).
• 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., PubMed 30903796 (JAMA, 2019).
• Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial., PubMed 37385279 (Lancet (London, England), 2023).
• A new era for oral peptides: SNAC and the development of oral semaglutide for the treatment of type 2 diabetes., PubMed 35838946 (Reviews in endocrine & metabolic disorders, 2022).

Listed for reference. Publication of a study is not a claim about this particular product.

Precautions

• This is a prescription medicine. Prescribing, dosing and follow-up belong to an endocrinologist.
• It is not used with a personal or family history of medullary thyroid carcinoma or with MEN 2 syndrome.
• Common unwanted reactions are nausea, vomiting, diarrhoea and reduced appetite. Severe, persistent abdominal pain calls for urgent medical help.
• Gallbladder problems and dehydration from vomiting or diarrhoea are possible. Hypoglycaemia is possible when it is taken together with insulin or sulfonylurea derivatives.
• Tell your doctor about kidney disease, diabetic retinopathy, pregnancy or plans for it: when pregnancy is planned the medicine is stopped in advance.
• Tell your doctor about every other medicine you take: interactions are possible.

Frequently asked