drugset / Trial / NCT01112670
The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology
Phase 4
Completed
33 enrolled
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedCrossoverOpen-label
Summary
The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and drug-drug interactions of sitagliptin therapy.
Timeline
- Start
- 2009-11
- Primary completion
- 2011-07
- Completion
- 2011-07
Outcome
Missed primary endpoint
registry analysis (superiority or other test); ABCB1 Group 1 vs ABCB1 Group 2 vs ABCB1 Group 3; p = 0.83; ANOVA NCT01112670 ↗
registry analysis (superiority or other test); ABCB1 Group 1 vs ABCB1 Group 2 vs ABCB1 Group 3; p = 0.67; ANOVA NCT01112670 ↗
registry analysis (superiority or other test); ABCB1 Group 1 vs ABCB1 Group 2 vs ABCB1 Group 3; p = 0.21; ANOVA NCT01112670 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 40 mg | — |
| Subject | Sitagliptin | Small molecule | 100 mg | — |
Indications
No indication recorded.