| Trial ID: | L6509 |
| Source ID: | NCT00760578
|
| Associated Drug: |
Placebo
|
| Title: |
A Placebo Controlled Safety and Efficacy Study of MSDC-0160 in Type 2 Diabetes With Active Comparator
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00760578/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Placebo|DRUG: Pioglitazone|DRUG: MSDC-0160 90 mg|DRUG: MSDC-0160 220 mg
|
| Outcome Measures: |
Primary: Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test, Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test., 28 days | Secondary: Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test, Change from baseline in averaged post prandial insulin levels in response to a mixed-meal tolerance test., After four weeks of active therapy|Change From Baseline in FFAs, Change from baseline in Free Fatty Acids (FFAs)following 28 days of active therapy, as part of a lipid profile assessment, After 28 days of active therapy|Change From Baseline in Triglycerides, Change compared to baseline in triglycerides following 28 days of active therapy, as part of a lipid profile assessment, 28 days|Change From Baseline in HDL, Change from baseline in HDL following 28 days of active therapy, as part of a lipid profile assessment, 28 days
|
| Sponsor/Collaborators: |
Sponsor: Metabolic Solutions Development Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
86
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-09
|
| Completion Date: |
2009-02
|
| Results First Posted: |
2013-05-03
|
| Last Update Posted: |
2013-05-03
|
| Locations: |
Los Angeles, California, United States|Miami Gardens, Florida, United States|West Palm Beach, Florida, United States|Kalamazoo, Michigan, United States|Greenville, South Carolina, United States|Dallas, Texas, United States|San Antonio, Texas, United States|Renton, Washington, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00760578
|
