Effect of LY333531 on Vascular and Neural Functions - Full Text View

Sponsors and Collaborators:	Eli Lilly and Company Joslin Diabetes Center
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00482976

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 II

MedlinePlus related topics: Diabetes

Drug Information available for: Ruboxistaurin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

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

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

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Metabolic Diseases
Ruboxistaurin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009