Effect of LY333531 on Vascular and Neural Functions
The Effects of a Protein Kinase C Beta Inhibitor, LY333531, on Vascular and Neural Functions in Type 2 Diabetes Mellitus - Study B7A-MC-MBDM
2 other identifiers
interventional
30
1 country
1
Brief Summary
To determine if protein kinase C beta plays a significant role in vascular endothelial dysfunction, small fiber neural dysfunction, and oxidative stress associated with diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus
Started Dec 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 4, 2007
CompletedFirst Posted
Study publicly available on registry
June 6, 2007
CompletedJuly 26, 2016
July 1, 2016
June 4, 2007
July 25, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation.
4 weeks
Improvement in endothelium-dependent vasodilation of the brachial artery (flow mediated dilation)
4 weeks
Improvement in selective measurements of oxidative stress, endothelial activity and vascular abnormalities which will correlate with PKC activity in the peripheral monocytes.
4 weeks
Secondary Outcomes (1)
Safety of ruboxistaurin
4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes diagnosed for at least 1 mo and less than 10 yrs prior to visit 1
- HbA1c less than 9% and fasting plasma glucose less than 260mg/dl
- Blood pressure less than 160/100 mmHg
- Total cholesterol less than 300 mg/dl and/or triglycerides less than 600 mg/dl
You may not qualify if:
- Subjects treated with a thiazolidinedione (TZD) in 12 weeks prior to visit 1.
- History of heart disease (MI, unstable angina, CVA, TIA, CABG, or percutaneous transluminal coronary angioplasty) w/in 6 months of visit 1 or subjects with BYHA class III or IV congestive heart failure.
- Female subjects of child-bearing potential that are pregnant or intend to become pregnant (i.e. not practicing an acceptable method of birth control)
- TSH greater than 1.5 times upper limit of normal at V1 or other endocrine disease.
- ALT greater than 1.5 times upper limit of normal at V1; Serum creatinine greater than 2.0mg/dl at V1; micro-albumin greater than 300.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chromaderm, Inc.lead
- Joslin Diabetes Centercollaborator
Study Sites (1)
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.
Boston, Massachusetts, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 4, 2007
First Posted
June 6, 2007
Study Start
December 1, 2003
Study Completion
March 1, 2005
Last Updated
July 26, 2016
Record last verified: 2016-07