25 mg
Trade Name
Sitaglu
Film-coated tablet
Request Type
New Registration
Drug Type
Generic
Approval Date
SFDA Approved Use
For adult patients with type 2 diabetes mellitus, Sitaglu is indicated to improve glycaemic control:
as monotherapy:
in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with:
metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
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.
a peroxisome proliferator-activated receptor gamma (PPARg) agonist (i.e. a thiazolidinedione) when use of a PPARg agonist is appropriate and when diet and exercise plus the PPARg agonist alone do not provide adequate glycaemic control.
as triple oral therapy in combination with:
a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
a PPARg agonist and metformin when use of a PPARg agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Sitagliptin beta 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.
as monotherapy:
in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with:
metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
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.
a peroxisome proliferator-activated receptor gamma (PPARg) agonist (i.e. a thiazolidinedione) when use of a PPARg agonist is appropriate and when diet and exercise plus the PPARg agonist alone do not provide adequate glycaemic control.
as triple oral therapy in combination with:
a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
a PPARg agonist and metformin when use of a PPARg agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Sitagliptin beta 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.