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The Effect of LY333531 on Protein in the Urine in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00044148
First Posted: August 21, 2002
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chromaderm, Inc.
  Purpose
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 Intervention Phase
Diabetic Nephropathy Drug: LY333531 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: The Effect of LY333531 on Albuminuria in Patients With Type 2 Diabetes A Pilot Clinical Trial

Resource links provided by NLM:


Further study details as provided by Chromaderm, Inc.:

Actual Study Start Date: July 16, 2002
Study Completion Date: April 28, 2004
Primary Completion Date: April 28, 2004 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044148


Locations
United States, California
La Jolla, California, United States
Walnut Creek, California, United States
United States, Florida
Jacksonville, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Waltham, Massachusetts, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
St Louis, Missouri, United States
United States, New York
New York, New York, United States
United States, North Carolina
Greenville, North Carolina, United States
United States, Texas
Dallas, Texas, United States
United States, Washington
Seattle, Washington, United States
Spokane, Washington, United States
Sponsors and Collaborators
Chromaderm, Inc.
  More Information

Responsible Party: Chromaderm, Inc.
ClinicalTrials.gov Identifier: NCT00044148     History of Changes
Other Study ID Numbers: 6249
B7A-MC-MBDA
First Submitted: August 20, 2002
First Posted: August 21, 2002
Last Update Posted: February 1, 2017
Last Verified: January 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chromaderm, Inc.:
Persistent Albuminuria

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ruboxistaurin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action