Clinical Trial Details
| Trial ID: | L5287 |
| Source ID: | NCT00377442 |
| Associated Drug: | Gk Activator (2) |
| Title: | A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes. |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus Type 2 |
| Interventions: | DRUG: GK Activator (2)|DRUG: Simvastatin |
| Outcome Measures: | Primary: AUC0-inf of GK Activator (2) and simvastatin acid., Days 1, 8 and 15|AUC0-6h of plasma glucose from pre-dose to 6h post-dose., Days 1, 8 and 15 | Secondary: AUC0-6h of GK Activator (2) and simvastatin acid, Days 1, 8 and 15|AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2., Days 1, 8 and 15|Cmin, tmin, Cmax, tmax, plasma glucose., Days 1, 8 and 15|AEs, laboratory parameters., Throughout study |
| Sponsor/Collaborators: | Sponsor: Hoffmann-La Roche |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 33 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2006-08 |
| Completion Date: | 2007-04 |
| Results First Posted: | |
| Last Update Posted: | 2016-11-02 |
| Locations: | San Antonio, Texas, 78229, United States|Tacoma, Washington, 98418, United States |
| URL: | https://clinicaltrials.gov/show/NCT00377442 |
