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

NCT ID: NCT00044148

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-16

Study Completion Date

2004-04-28

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Nephropathy

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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LY333531

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chromaderm, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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La Jolla, California, United States

Site Status

Walnut Creek, California, United States

Site Status

Jacksonville, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Lexington, Kentucky, United States

Site Status

Baltimore, Maryland, United States

Site Status

Waltham, Massachusetts, United States

Site Status

Minneapolis, Minnesota, United States

Site Status

St Louis, Missouri, United States

Site Status

New York, New York, United States

Site Status

Greenville, North Carolina, United States

Site Status

Dallas, Texas, United States

Site Status

Seattle, Washington, United States

Site Status

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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B7A-MC-MBDA

Identifier Type: -

Identifier Source: secondary_id

6249

Identifier Type: -

Identifier Source: org_study_id

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