SITAGLIPTIN PHOSPHATE
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 should not be used in patients with type 1 diabetes. 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.
Details
- Status
- Prescription
- First Approved
- 2025-12-29
- Routes
- ORAL, FILM COATED
- Dosage Forms
- TABLET
Companies
SITAGLIPTIN PHOSPHATE Approval History
What SITAGLIPTIN PHOSPHATE Treats
3 FDA approvalsOriginally approved for its first indication in 2025 . Covers 3 distinct patient populations.
- Other (3)
SITAGLIPTIN PHOSPHATE Target & Pathway
ProTarget
A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01131182 results posted | 0431-263 2010_538 | Ph 4 | completed | Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263) |
| NCT01177384 results posted | 0431-130 2010_543, CTRI/2011/10/002072 | Ph 3 | completed | Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130) |
| NCT01076075 results posted | 0431-229 2010_513, MK-0431-229 | Ph 3 | completed | A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229) |
| NCT01189890 results posted | 0431-251 | Ph 3 | completed | Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251) |
| NCT01034111 results posted | 0431-178 2009_705 | Ph 3 | completed | A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178) |
| NCT00833027 results posted | 0431-103 MK0431-103, 2009_527 | Ph 4 | completed | ALPHA Sitagliptin Add on to Metformin (0431-103) |
| NCT00830076 results posted | 0431-110 2009_521 | Ph 1 | completed | A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110) |
| NCT00722371 results posted | 0431-102 2008_522 | Ph 3 | completed | MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2) |
| NCT00730275 results posted | 0431-081 2008_540 | Ph 1 | completed | A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081) |
| NCT00929201 results posted | 0431A-080 MK-0431A-080, 2009_607 | Ph 1 | completed | Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080) |
| NCT00642798 | 0431-108 2008_002 | Ph 1 | completed | An Open-Label, Single- & Multiple-Dose Study to Investigate the Pharmacokinetics of Sitagliptin 100 mg in Healthy Chinese Adult Subjects (0431-108)(COMPLETED) |
| NCT00847080 | MK-0431 | Ph 4 | completed | Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SITAGLIPTIN PHOSPHATE FDA Label Details
Indications & Usage
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 should not be used in patients with type 1 diabetes. 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 .] Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exer...
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Full clinical data, patents, trials, and competitive landscape for sitagliptin phosphate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.