Isoprostane/FMD Study The Effect of Protein Kinase C (PKC) β Specific Inhibitor LY333531 on Oxidant Stress in Patients With Type 2 Diabetes Mellitus

July 25, 2016 updated by: Chromaderm, Inc.

The Effect of Protein Kinase C (PKC) β Specific Inhibitor on Oxidant Stress in Patient With Type 2 Diabetes Mellitus

The purpose of this study is to determine whether ruboxistaurin can reduce blood vessel inflammation associated with diabetes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Type 2 diabetes mellitus
  2. ≥35 years of age
  3. Fasting low-density lipoprotein (LDL) cholesterol <160 mg/dL, triglycerides (TG) <400 mg/dL
  4. Sitting systolic blood pressure <160 mm Hg and sitting diastolic blood pressure <90 mm Hg as determined by the mean of three separate measurements.

  5. Hemoglobin A1c (HbA1c) ≥7% and ≤11%.

    Exclusion Criteria:

  6. A serum creatinine >2.0 mg/dL or who have received a renal transplant or are currently being treated with dialysis.
  7. Alanine aminotransaminase (ALT), alkaline phosphatase (ALP), or total bilirubin (TB) greater than two times the upper limit of normal
  8. Current use of aspirin, nitroglycerin or long-acting nitrates or potential need for use of aspirin, nitroglycerin or long-acting nitrates to treat documented cerebrovascular or coronary artery disease during the study.
  9. Use of tobacco products (for example, cigarettes, cigars, pipes, and snuff) within the 6 months prior to Visit 1.
  10. Requirement for treatment with very potent inhibitors of cytochrome P450 3A4 or inhibitors of cytochrome P450 2D6.
  11. Requirement for treatment with inducers of cytochrome P450 3A4.
  12. Active infection/inflammation as determined by body temperature >38°C OR current use of systemic antibacterial, antifungal, or antiviral medication OR active chronic inflammation (for example, lupus, rheumatoid arthritis, multiple sclerosis).
  13. Abdominal, thoracic, vascular, or cranial surgery that is determined to be of major significance by the investigator within 3 months prior to Visit 1.
  14. Current suspicion of carcinoma or treatment for cancer within 6 months prior to Visit 1 or anticipated treatment for cancer during the course of the study, with the exception of superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
  15. Patients who have taken any non-steroidal anti-inflammatory agents (including aspirin and cyclooxygenase-2 inhibitors) or vitamins within 14 days of entry (Visit 1).
  16. Patients who have previously completed or withdrawn from this study or any other study investigating LY333531 (unless the patient is being re-screened 14 days or more after discontinuing the use of vitamins or non-steroidal anti-inflammatory agents.
  17. Directly affiliated with the conduct of this study, or are immediate family of someone directly affiliated with the conduct of this study (that is, Lilly employees, investigators, site personnel, or their immediate families). Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  18. Treatment with an investigational drug within the last 30 days at the time of study entry.
  19. Females of child-bearing potential (not surgically sterilized and between menarche and <5 years post menopause) who test positive for pregnancy at the time of enrollment based on a serum pregnancy test or who intend to become pregnant during the study.
  20. Females of child-bearing potential who do not agree to use a reliable method of birth control (for example, use of oral contraceptives or Norplant®; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy; or abstinence) during the study.
  21. A female who is breast-feeding.
  22. Any other findings, in the opinion of the investigator, that would preclude the patient's participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: ruboxistaurin
oral 32 mg daily
Other Names:
  • LY333531
Placebo Comparator: 2
Other: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary efficacy measure is the ratio of urinary isoprostane to creatinine as measured by gas chromatography/mass spectrometry (GC/MS) in the two consecutive 12-hour urine samples obtained prior to both Visit 2 (baseline) and Visit 3 (endpoint).
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Increase in brachial artery diameter induced by reactive hyperemia as measured by ultrasound (flow-mediated dilatation) at Visits 2 and 3.
Time Frame: 6 weeks
6 weeks
The ratio of urinary albumin to creatinine
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chromaderm, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Muredach Reilly, MD, University of Pennsylvania, Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2002

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6038 (Other Identifier: CTEP)
  • B7A-MC-MBCZ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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