Diabetes MellitusPhase 1NCT00552227
Isoprostane/FMD Study The Effect of Protein Kinase C (PKC) β Specific Inhibitor LY333531 on Oxidant Stress in Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing ruboxistaurin in people with Diabetes Mellitus, run by Chromaderm, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether ruboxistaurin can reduce blood vessel inflammation associated with diabetes. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- ruboxistaurin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Jul 2005
- Phase
- Phase 1
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- ≥35 years of age
- Fasting low-density lipoprotein (LDL) cholesterol <160 mg/dL, triglycerides (TG) <400 mg/dL
- Sitting systolic blood pressure <160 mm Hg and sitting diastolic blood pressure <90 mm Hg as determined by the mean of three separate measurements.
- Hemoglobin A1c (HbA1c) ≥7% and ≤11%.
Who cannot join
- A serum creatinine >2.0 mg/dL or who have received a renal transplant or are currently being treated with dialysis.
- Alanine aminotransaminase (ALT), alkaline phosphatase (ALP), or total bilirubin (TB) greater than two times the upper limit of normal
- 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.
- Use of tobacco products (for example, cigarettes, cigars, pipes, and snuff) within the 6 months prior to Visit 1.
- Requirement for treatment with very potent inhibitors of cytochrome P450 3A4 or inhibitors of cytochrome P450 2D6.
- Requirement for treatment with inducers of cytochrome P450 3A4.
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- 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).
- Abdominal, thoracic, vascular, or cranial surgery that is determined to be of major significance by the investigator within 3 months prior to Visit 1.
- 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.
- 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).
- 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.
- 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.
- Treatment with an investigational drug within the last 30 days at the time of study entry.
- 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.
- 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.
- A female who is breast-feeding.
- Any other findings, in the opinion of the investigator, that would preclude the patient's participation in the study.
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.
Philadelphia, Pennsylvania
About this study
Official title: 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.
- 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
Also called LY333531
oral 32 mg daily
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ruboxistaurin |
| 2 | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (2)
Increase in brachial artery diameter induced by reactive hyperemia as measured by ultrasound (flow-mediated dilatation) at Visits 2 and 3.
Measured: 6 weeks
The ratio of urinary albumin to creatinine
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startSep 2002
- Study completionJul 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chromaderm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Muredach Reilly, MD, Principal investigator, University of Pennsylvania, Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552227
- Sponsor's protocol ID
- 6038
- Other IDs
- B7A-MC-MBCZ
- Status last verified
- Jul 2016
- First submitted
- 30 Oct 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 Effect of Protein Kinase C (PKC) β Specific Inhibitor on Oxidant Stress in Patient With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00552227
- Acronym / sponsor ID
- 6038
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chromaderm, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2002
- Study completion
- Jul 2005 (actual)
- First posted
- 1 Nov 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.
The purpose of this study is to determine whether ruboxistaurin can reduce blood vessel inflammation associated with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ruboxistaurin |
| 2 | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus
- ≥35 years of age
- Fasting low-density lipoprotein (LDL) cholesterol <160 mg/dL, triglycerides (TG) <400 mg/dL
- Sitting systolic blood pressure <160 mm Hg and sitting diastolic blood pressure <90 mm Hg as determined by the mean of three separate measurements.
- Hemoglobin A1c (HbA1c) ≥7% and ≤11%.
Key exclusion criteria (17 listed)
- A serum creatinine >2.0 mg/dL or who have received a renal transplant or are currently being treated with dialysis.
- Alanine aminotransaminase (ALT), alkaline phosphatase (ALP), or total bilirubin (TB) greater than two times the upper limit of normal
- 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.
- Use of tobacco products (for example, cigarettes, cigars, pipes, and snuff) within the 6 months prior to Visit 1.
- Requirement for treatment with very potent inhibitors of cytochrome P450 3A4 or inhibitors of cytochrome P450 2D6.
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 |
|---|---|---|
| ruboxistaurinAlso: LY333531oral 32 mg daily | Drug | 1 |
| placeboplacebo | Other | 2 |
Primary outcome
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
2 secondary outcomes
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
The ratio of urinary albumin to creatinine
Time frame: 6 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.
Muredach Reilly, MD principal investigator
University of Pennsylvania, Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 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 5 inclusion and 17 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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). 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.