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Effect of LY333531 on Vascular and Neural Functions

This study has been completed.
Sponsor:
Collaborator:
Joslin Diabetes Center
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00482976
First received: June 4, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 4, 2007
June 4, 2007
December 2003
Not Provided
  • Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation. [ Time Frame: 4 weeks ]
  • Improvement in endothelium-dependent vasodilation of the brachial artery (flow mediated dilation) [ Time Frame: 4 weeks ]
  • Improvement in selective measurements of oxidative stress, endothelial activity and vascular abnormalities which will correlate with PKC activity in the peripheral monocytes. [ Time Frame: 4 weeks ]
Same as current
No Changes Posted
Safety of ruboxistaurin [ Time Frame: 4 weeks ]
Same as current
Not Provided
Not Provided
 
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

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.

32mg Ruboxistaurin; 4 week cross-over treatment.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: Ruboxistaurin
  • Drug: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2005
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00482976
7546, B7A-MC-MBDM
No
Not Provided
Eli Lilly and Company
Joslin Diabetes Center
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
Eli Lilly and Company
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP