Back to resultsThe Effect of LY333531 on Protein in the Urine in Patients With Type 2 Diabetes
Primary Purpose
Diabetic Nephropathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LY333531
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Persistent Albuminuria
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00044148
Brief Title
The Effect of LY333531 on Protein in the Urine in Patients With Type 2 Diabetes
Official Title
The Effect of LY333531 on Albuminuria in Patients With Type 2 Diabetes A Pilot Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 16, 2002 (Actual)
Primary Completion Date
April 28, 2004 (Actual)
Study Completion Date
April 28, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chromaderm, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
Persistent Albuminuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
LY333531
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
City
La Jolla
State/Province
California
Country
United States
City
Walnut Creek
State/Province
California
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Waltham
State/Province
Massachusetts
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
St Louis
State/Province
Missouri
Country
United States
City
New York
State/Province
New York
Country
United States
City
Greenville
State/Province
North Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Spokane
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of LY333531 on Protein in the Urine in Patients With Type 2 Diabetes
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