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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00482976

Enrollment

Registered

2007-06-06

Start date

2003-12-31

Completion date

2005-03-31

Last updated

2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Detailed description

32mg Ruboxistaurin; 4 week cross-over treatment.

Interventions

DRUGRuboxistaurin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Measure	Time frame
Safety of ruboxistaurin	4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026