<p>Sitagliptin SUN is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It is used together with diet and exercise in the following ways:</p><ul><li>on its own, in patients whose blood glucose levels are not satisfactorily controlled with diet and exercise and who cannot take metformin (a diabetes medicine);</li><li>in combination with metformin or a PPAR-gamma agonist (a type of diabetes medicine) such as a thiazolidinedione, in patients whose blood glucose levels are not satisfactorily controlled with metformin or the PPAR-gamma agonist used on its own;</li><li>in combination with a sulphonylurea (another diabetes medicine) in patients whose blood glucose levels are not satisfactorily controlled with a sulphonylurea used on its own and who cannot take metformin;</li><li>in combination with both metformin and a sulphonylurea or a PPAR-gamma agonist, in patients whose blood glucose levels are not satisfactorily controlled with the two medicines;</li><li>in combination with insulin, with or without metformin, in patients whose blood glucose levels are not satisfactorily controlled with a stable dose of insulin.</li></ul><p>Sitagliptin SUN contains the active substance sitagliptin and is a ‘generic medicine’. This means that Sitagliptin SUN contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Januvia. For more information on generic medicines, see the question-and-answer document <a href="https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf">here</a>.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>For adult patients with type 2 diabetes mellitus, Sitagliptin SUN is indicated to improve glycaemic control:</p><p>as monotherapy:<br>- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.</p><p>as dual oral therapy in combination with:<br>- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.<br>- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.<br>- a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control.</p><p>as triple oral therapy in combination with:<br>- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.<br>- a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.</p><p>Sitagliptin SUN is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.</p></div>
Therapeutic Area (MeSH)
ATC Code
A10BH01
ATC Item
N/A
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| sitagliptin fumarate | N/A | sitagliptin fumarate |
EMA Name
Sitagliptin SUN
Medicine Name
Sitagliptin SUN
Aliases
N/ANo risk management plan link.
