The Effect of LY333531 on Protein in the Urine in Patients With Type 2 Diabetes
Sponsor
Chromaderm, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00044148
Collaborator
(none)
15
21.4
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
The Effect of LY333531 on Albuminuria in Patients With Type 2 Diabetes A Pilot Clinical Trial
Actual Study Start Date
:
Jul 16, 2002
Actual Primary Completion Date
:
Apr 28, 2004
Actual Study Completion Date
:
Apr 28, 2004
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | La Jolla | California | United States | ||
| 2 | Walnut Creek | California | United States | ||
| 3 | Jacksonville | Florida | United States | ||
| 4 | Atlanta | Georgia | United States | ||
| 5 | Chicago | Illinois | United States | ||
| 6 | Lexington | Kentucky | United States | ||
| 7 | Baltimore | Maryland | United States | ||
| 8 | Waltham | Massachusetts | United States | ||
| 9 | Minneapolis | Minnesota | United States | ||
| 10 | St Louis | Missouri | United States | ||
| 11 | New York | New York | United States | ||
| 12 | Greenville | North Carolina | United States | ||
| 13 | Dallas | Texas | United States | ||
| 14 | Seattle | Washington | United States | ||
| 15 | Spokane | Washington | United States |
Sponsors and Collaborators
- Chromaderm, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Chromaderm, Inc.
ClinicalTrials.gov Identifier:
NCT00044148
Other Study ID Numbers:
- 6249
- B7A-MC-MBDA
First Posted:
Aug 21, 2002
Last Update Posted:
Feb 1, 2017
Last Verified:
Jan 1, 2017
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chromaderm, Inc.
Additional relevant MeSH terms: