A Study Comparing the Pharmacokinetic and Pharmacodynamic Profiles for Sitagliptin, Saxagliptin and Vildagliptin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-142)
Summary
A five-period crossover study to assess and compare the trough dipeptidyl peptidase IV (DPP-4) inhibition at 24-hours following the final morning dose for sitagliptin, saxagliptin and vildagliptin after 5 days of once daily dosing and vildagliptin after 5 days of twice daily dosing in participants with T2DM. The primary hypothesis is that following multiple daily dose administration to achieve steady-state drug concentrations, 100-mg sitagliptin will demonstrate greater DPP-4 inhibition at 24-hours after the final dose compared to 5-mg saxagliptin and 50-mg vildagliptin (once daily administration) in participants with T2DM. Each participant will receive all 5 treatments in randomized order. There will be a washout interval of at least 10 days between the last dose of study drug in one period and the first dose of study drug in the following period.
Timeline
- Start
- 2012-06-21
- Primary completion
- 2012-12-04
- Completion
- 2012-12-14
Outcome
Met primary endpoint
registry Sitagliptin 100 mg vs Saxagliptin 5 mg; p <.001; Least squares mean difference 18.24 (90% CI 14.97 to 21.67) NCT01582308 ↗
paper Once daily treatment with sitagliptin provided trough DPP-4 inhibition significantly greater than saxagliptin or vildagliptin administered once daily, and similar to that provided by vildagliptin administered twice daily. PMID 24163113 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAXAGLIPTIN ANHYDROUS | Small molecule | 5 mg | — |
| Subject | Sitagliptin | Small molecule | 100 mg | — |
| Subject | Vildagliptin | Other / unclassified | 50 mg | — |