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

January 30, 2017 updated by: Chromaderm, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States
      • Walnut Creek, California, United States
    • Florida
      • Jacksonville, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Waltham, Massachusetts, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • St Louis, Missouri, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Greenville, North Carolina, United States
    • Texas
      • Dallas, Texas, United States
    • Washington
      • Seattle, Washington, United States
      • Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chromaderm, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2002

Primary Completion (Actual)

April 28, 2004

Study Completion (Actual)

April 28, 2004

Study Registration Dates

First Submitted

August 20, 2002

First Submitted That Met QC Criteria

August 20, 2002

First Posted (Estimate)

August 21, 2002

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6249
  • B7A-MC-MBDA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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