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

This study has been completed.

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00044148

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 II

MedlinePlus related topics: Diabetes Diabetic Kidney Problems

Drug Information available for: Ruboxistaurin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Eli Lilly and Company

More Information

Study ID Numbers:	6249, B7A-MC-MBDA
Study First Received:	August 20, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00044148
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Persistent Albuminuria

Study placed in the following topic categories:

Albuminuria
Diabetic Nephropathies
Urologic Diseases
Ruboxistaurin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Kidney Diseases
Diabetes Complications

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009