Effect of LY333531 on Vascular and Neural Functions

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482976
• Other study ID #: 7546
• Secondary ID: B7A-MC-MBDM
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2007
• Last updated: July 25, 2016
• Start date: December 2003
• Est. completion date: March 2005

Study information

• Verified date: July 2016
• Source: Chromaderm, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

32mg Ruboxistaurin; 4 week cross-over treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Ruboxistaurin

• Placebo

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Chromaderm, Inc.	Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation.		4 weeks
Primary	Improvement in endothelium-dependent vasodilation of the brachial artery (flow mediated dilation)		4 weeks
Primary	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	Safety of ruboxistaurin		4 weeks

External Links

•   Lilly Clinical Trial Registry