Sitagliptin: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Sitagliptin appears in the FDA drug-label database. Marketed as Sitagliptin.
- Drug class
- Dipeptidyl Peptidase 4 Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Dipeptidyl Peptidase 4 Inhibitors (as stated on the FDA label)
FDA-approved use
Sitagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin Tablets is not recommended in patients with type 1 diabetes mellitus. Sitagliptin Tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Sitagliptin Tablets. [see Warnings and Precautions (5.1) ]. Sitagliptin Tablets are a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Sitagliptin Tablets are not recommended in patients with type 1 diabetes mellitus. ( 1 ) Sitagliptin Tablets has not been studied in patients with a history of pancreatitis. ( 1 )
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of foreign substance: Presence of stainless steel particulates in tablets. — MERCK SHARP & DOHME CORP | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-03-31 |
Phase breakdown
Conditions being studied
Recruiting trials involving Sitagliptin
- Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
- Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment
- Sitagliptin With Pembro in RCC and Melanoma
- Sitagliptin or BeiDouGen Capsule Improve the Pregnancy Outcome in Patients with PCOS
Common questions
Is Sitagliptin FDA-approved?
Yes, marketed as Sitagliptin.
How many recruiting trials involve Sitagliptin?
4 recruiting trials across 9 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.