| Trial ID: | L1969 |
| Source ID: | NCT00552227
|
| Associated Drug: |
Ruboxistaurin
|
| Title: |
Isoprostane/FMD Study The Effect of Protein Kinase C (PKC) β Specific Inhibitor LY333531 on Oxidant Stress in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: ruboxistaurin|OTHER: placebo
|
| Outcome Measures: |
Primary: The primary efficacy measure is the ratio of urinary isoprostane to creatinine as measured by gas chromatography/mass spectrometry (GC/MS) in the two consecutive 12-hour urine samples obtained prior to both Visit 2 (baseline) and Visit 3 (endpoint)., 6 weeks | Secondary: Increase in brachial artery diameter induced by reactive hyperemia as measured by ultrasound (flow-mediated dilatation) at Visits 2 and 3., 6 weeks|The ratio of urinary albumin to creatinine, 6 weeks
|
| Sponsor/Collaborators: |
Sponsor: Chromaderm, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2002-09
|
| Completion Date: |
2005-07
|
| Results First Posted: |
|
| Last Update Posted: |
2016-07-26
|
| Locations: |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 am to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Philadelphia, Pennsylvania, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00552227
|
