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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00552227
Recruitment Status : Completed
First Posted : November 1, 2007
Last Update Posted : July 26, 2016
Information provided by:
Chromaderm, Inc.

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: ruboxistaurin Other: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Protein Kinase C (PKC) β Specific Inhibitor on Oxidant Stress in Patient With Type 2 Diabetes Mellitus
Study Start Date : September 2002
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: ruboxistaurin
oral 32 mg daily
Other Name: LY333531

Placebo Comparator: 2 Other: placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. The ratio of urinary albumin to creatinine [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00552227

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United States, Pennsylvania
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.
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Chromaderm, Inc.
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Principal Investigator: Muredach Reilly, MD University of Pennsylvania, Philadelphia

Additional Information:
Layout table for additonal information Identifier: NCT00552227     History of Changes
Other Study ID Numbers: 6038
First Posted: November 1, 2007    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action