Diabetes MellitusPhase 2NCT00482976
Effect of LY333531 on Vascular and Neural Functions
A Phase 2 study testing Ruboxistaurin in people with Diabetes Mellitus, run by Chromaderm, Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Ruboxistaurin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Mar 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 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
About this study
Official 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
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Ruboxistaurin, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuboxistaurinDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation.
Measured: 4 weeks
Improvement in endothelium-dependent vasodilation of the brachial artery (flow mediated dilation)
Measured: 4 weeks
Improvement in selective measurements of oxidative stress, endothelial activity and vascular abnormalities which will correlate with PKC activity in the peripheral monocytes.
Measured: 4 weeks
Secondary outcomes (1)
Safety of ruboxistaurin
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2007 (estimated)
- Study startDec 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chromaderm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Joslin Diabetes Center
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482976
- Sponsor's protocol ID
- 7546
- Other IDs
- B7A-MC-MBDM
- Status last verified
- Jul 2016
- First submitted
- 4 Jun 2007
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00482976
- Acronym / sponsor ID
- 7546
- Conditions
- Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chromaderm, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Joslin Diabetes Center
- Study start
- Dec 2003
- Study completion
- Mar 2005 (actual)
- First posted
- 6 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruboxistaurin | Drug | – |
| Placebo | Drug | – |
Primary outcome
Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation.
Time frame: 4 weeks
Improvement in endothelium-dependent vasodilation of the brachial artery (flow mediated dilation)
Time frame: 4 weeks
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
1 secondary outcome
Safety of ruboxistaurin
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruboxistaurin in people with Diabetes Mellitus, run by Chromaderm, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation. (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.