Diabetic NephropathyPhase 2NCT00044148
The Effect of LY333531 on Protein in the Urine in Patients With Type 2 Diabetes
A Phase 2 study testing LY333531 in people with Diabetic Nephropathy, run by Chromaderm, Inc. at 15 sites in United States.
Trial summary
The purpose of this study are to determine 1) Whether Ly333531 can reduce urinary albumin/creatinine excretion in patients with Type II diabetes and persistent albuminuria 2) Whether LY333531 reduces urinary TGF-B, 3) the safety of LY333531 and any side effects that may be associated with it. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- LY333531
- How many people
- Not given
- Where
- 15 sitesUnited States
- Study dates
- 16 Jul 2002to 28 Apr 2004
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Greater than or equal to 30 years of age
- Albumin to Creatinine ratio (greater than 200 mg/g and less than 2000 mg/g) 4)Without language barrier.
Who cannot join
- Serum Creatinine greater than 2.0 mg/dl males or greater than 1.7 mg/dl females
- B/P greater than 150 systolic and greater than 90 diastolic
- Hemoglobin Alc greater than 11%
- Liver Function Tests 2 times upper limit of normal
- Poor medical or psychiatric risk.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Study site
Atlanta, Georgia
Study site
Baltimore, Maryland
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Greenville, North Carolina
Study site
Jacksonville, Florida
Study site
La Jolla, California
Study site
Lexington, Kentucky
Study site
Minneapolis, Minnesota
Study site
New York, New York
Study site
Seattle, Washington
Study site
Spokane, Washington
Study site
St Louis, Missouri
Study site
Walnut Creek, California
Study site
Waltham, Massachusetts
About this study
Official title: The Effect of LY333531 on Albuminuria in Patients With Type 2 Diabetes A Pilot Clinical Trial
The purpose of this study are to determine 1) Whether Ly333531 can reduce urinary albumin/creatinine excretion in patients with Type II diabetes and persistent albuminuria 2) Whether LY333531 reduces urinary TGF-B, 3) the safety of LY333531 and any side effects that may be associated with it.
- Conditions
- Diabetic Nephropathy
- Being tested
- LY333531
- Keywords
- Persistent Albuminuria
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY333531Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2002 (estimated)
- Study start16 Jul 2002
- Primary completion28 Apr 2004
- Study completion28 Apr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies 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
Sponsor and investigators
- Lead sponsor
- Chromaderm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044148
- Sponsor's protocol ID
- 6249
- Other IDs
- B7A-MC-MBDA
- Status last verified
- Jan 2017
- First submitted
- 20 Aug 2002
- Last updated
- 1 Feb 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of LY333531 on Albuminuria in Patients With Type 2 Diabetes A Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT00044148
- Acronym / sponsor ID
- 6249
- Conditions
- Diabetic Nephropathy
- Keywords
- Persistent Albuminuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chromaderm, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2002 (actual)
- Primary completion
- 28 Apr 2004 (actual)
- Study completion
- 28 Apr 2004 (actual)
- First posted
- 21 Aug 2002 (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 are to determine 1) Whether Ly333531 can reduce urinary albumin/creatinine excretion in patients with Type II diabetes and persistent albuminuria 2) Whether LY333531 reduces urinary TGF-B, 3) the safety of LY333531 and any side effects that may be associated with it.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus
- Greater than or equal to 30 years of age
- Albumin to Creatinine ratio (greater than 200 mg/g and less than 2000 mg/g) 4)Without language barrier.
Key exclusion criteria (5 listed)
- Serum Creatinine greater than 2.0 mg/dl males or greater than 1.7 mg/dl females
- B/P greater than 150 systolic and greater than 90 diastolic
- Hemoglobin Alc greater than 11%
- Liver Function Tests 2 times upper limit of normal
- Poor medical or psychiatric risk.
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 |
|---|---|---|
| LY333531 | Drug | – |
Primary outcome
Not reported in the source record.
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 1 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY333531 in people with Diabetic Nephropathy, run by Chromaderm, Inc. at 15 sites 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 3 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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.
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 1 Feb 2017.