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Effect of LY333531 on Vascular and Neural Functions

Sponsor
Chromaderm, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00482976
Collaborator
Joslin Diabetes Center (Other)
30
Enrollment
1
Location
15
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

32mg Ruboxistaurin; 4 week cross-over treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
The Effects of a Protein Kinase C Beta Inhibitor, LY333531, on Vascular and Neural Functions in Type 2 Diabetes Mellitus - Study B7A-MC-MBDM
Study Start Date :
Dec 1, 2003
Actual Study Completion Date :
Mar 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation. [4 weeks]

  2. Improvement in endothelium-dependent vasodilation of the brachial artery (flow mediated dilation) [4 weeks]

  3. 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 Outcome Measures

  1. Safety of ruboxistaurin [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
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

Sponsors and Collaborators

  • Chromaderm, Inc.
  • Joslin Diabetes Center

Investigators

  • 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 Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00482976
Other Study ID Numbers:
  • 7546
  • B7A-MC-MBDM
First Posted:
Jun 6, 2007
Last Update Posted:
Jul 26, 2016
Last Verified:
Jul 1, 2016
Additional relevant MeSH terms:
Diabetes Mellitus
Ruboxistaurin

Study Results

No Results Posted as of Jul 26, 2016