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
  Purpose

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 Intervention Phase
Diabetes Mellitus
Drug: Ruboxistaurin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Safety of ruboxistaurin [ Time Frame: 4 weeks ]

Enrollment: 30
Study Start Date: December 2003
Study Completion Date: March 2005
Detailed Description:

32mg Ruboxistaurin; 4 week cross-over treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482976

Locations
United States, Massachusetts
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
Eli Lilly and Company
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00482976     History of Changes
Other Study ID Numbers: 7546, B7A-MC-MBDM
Study First Received: June 4, 2007
Last Updated: June 4, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ruboxistaurin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014