Sitagliptin
Approved · EMAAlso known as Brynovin, Janumet, Janumet XR, Januvia+7 more
Brynovin, Janumet, Janumet XR, Januvia, Juvisync, Steglujan, Zituvimet, Zituvio, Sitagliptina, Sitagliptine, Sitagliptinum.
Recent clinical, regulatory, research and industry developments relating to this drug.
Evidence confidence
How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.
— 35 supporting evidence families · 8 well-powered no-effect results
Confidence is moderated by well-powered no-effect evidence and limited publication incorporation, despite broad trial support.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: For adult patients with type-2 diabetes mellitus, Ristaben is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise… Show full indicationShow less
For adult patients with type-2 diabetes mellitus, Ristaben 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 (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; 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 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. Ristaben 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.
Indication: For patients with type-2 diabetes mellitus, Tesavel is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and… Show full indicationShow less
For patients with type-2 diabetes mellitus, Tesavel 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 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; as triple oral therapy in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control; a peroxisome-proliferator-activated-receptor-gamma (PPAR?) agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. Tesavel is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control.
Indication: For adult patients with type-2 diabetes mellitus, Xelevia is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise… Show full indicationShow less
For adult patients with type-2 diabetes mellitus, Xelevia 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 (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; 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 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. Xelevia 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.
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Effects of Sitagliptin in Individuals With Genetically Decreased DPP4
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes2
Journals, researchers & institutions
- Diabetes, obesity & metabolism5
- Diabetes care2
- The Journal of clinical endocrinology and metabolism2
- American heart journal1
- American journal of kidney diseases : the official journal of the National Kidney Foundation1
- American journal of physiology. Endocrinology and metabolism1
- Kaufman KD7
- Engel SS4
- Arjona Ferreira JC3
- Bethel MA3
- Goldstein BJ3
- Green JB3
- Holman RR3
- Holst JJ3
- Garvan Institute of Medical Research2
- Washington University School of Medicine2
- Banting and Best Diabetes Centre1
- Beijing Pinggu Hospital No. 591
- Cambridge Institute of Medical Research and Department of Clinical Biochemistry1
- Center for Human Nutrition1
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.