| Trial ID: | L6350 |
| Source ID: | NCT00422487
|
| Associated Drug: |
Mbx-2044
|
| Title: |
Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: MBX-2044|DRUG: MBX-2044|DRUG: MBX-2044|DRUG: MBX-2044|DRUG: MBX-2044|DRUG: MBX-2044|DRUG: Placebo for MBX-2044
|
| Outcome Measures: |
Primary: Evaluate the multiple-dose pharmacokinetics of MBX-2044 administered as monotherapy at the protocol-specified daily dose orally for 14 days|Evaluate the clinical safety and tolerability of MBX-2044 after 14 days administration, including the parameters of weight gain and edema|Determine the maximum tolerated dose (MTD) of MBX-2044, after 14 days administration|Determine the effect of MBX-2044 after 14 days administration, on efficacy parameters |
|
| Sponsor/Collaborators: |
Sponsor: Gilead Sciences
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-10
|
| Completion Date: |
2007-09
|
| Results First Posted: |
|
| Last Update Posted: |
2015-05-01
|
| Locations: |
Diabetes and Glandular Disease Research Associates, San Antonio, Texas, 78229-4801, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00422487
|
