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CompletedNCT00482976Updated Jul 26, 2016

Effect of LY333531 on Vascular and Neural Functions

A Phase 2 interventional study of Ruboxistaurin and Placebo in Diabetes Mellitus, sponsored by Chromaderm, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-07-26.

Sponsored by Chromaderm, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

32mg Ruboxistaurin; 4 week cross-over treatment.

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Chromaderm, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
30 participants (actual)

Interventions

  • DrugRuboxistaurin
  • DrugPlacebo
06

What researchers measure

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

07

Study locations

1 site
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00482976
Lead sponsor
Chromaderm, Inc.
Collaborators
Joslin Diabetes Center
First posted
Jun 6, 2007
Start date
Dec 2003
Completion
Mar 2005
Last update
Jul 26, 2016

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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Chromaderm, Inc.

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