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OpenTrials
Completed

NCT Number: NCT00482976

Effect of LY333531 on Vascular and Neural Functions

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

About this study

32mg Ruboxistaurin; 4 week cross-over treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ruboxistaurin

Drug

Placebo

Drug

Primary outcomes

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

    Time frame: 4 weeks

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

    Time frame: 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.

    Time frame: 4 weeks

Secondary outcomes

  1. Safety of ruboxistaurin

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Chromaderm, Inc.

Industry

Collaborators

  • Joslin Diabetes Center

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2005
First posted
Jun 6, 2007
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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