Clinical Trial Details
| Trial ID: | L4225 |
| Source ID: | NCT00302224 |
| Associated Drug: | 2s, 4r Ketoconazole (Dio-902) |
| Title: | A Phase 1/2a Study of the 2S,4R Enantiomer of Ketoconazole in Subjects With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: 2S, 4R Ketoconazole (DIO-902) |
| Outcome Measures: | Primary: To evaluate the safety and tolerability of 14 daily doses; To determine the pharmacokinetic (PK) profile in plasma of DIO-902 after a single dose, and after fourteen daily doses; To evaluate the pharmacodynamic effects of fourteen daily doses | Secondary: To explore the impact of treatment with the enantiomer of ketoconazole on markers of inflammation and coagulation as well as on lipomic profiles, pre- and post-treatment |
| Sponsor/Collaborators: | Sponsor: DiObex |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1|PHASE2 |
| Enrollment: | 50 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT |
| Start Date: | 2005-02 |
| Completion Date: | 2006-08 |
| Results First Posted: | |
| Last Update Posted: | 2008-02-22 |
| Locations: | Asha Thomas, MD - Medstar, Washington DC, District of Columbia, 20003, United States|Marc Rendell, MD - Creighton University, Omaha, Nebraska, 68131, United States|Dr. Andrew Ahmann, MD - Radiant Research, Portland, Oregon, 97239, United States|Carlos Arauz-Pacheco, MD - Radiant Research, Dallas, Texas, 75247, United States|Sherwin Schwartz, MD - Diabetes and Glandular Disease Clinic, San Antonio, Texas, 78229, United States |
| URL: | https://clinicaltrials.gov/show/NCT00302224 |
