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

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.

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

La Jolla, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY333531

Drug

Sponsors and collaborators

Lead sponsor

Chromaderm, Inc.

Industry

Registry information

Official study title

The Effect of LY333531 on Albuminuria in Patients With Type 2 Diabetes A Pilot Clinical Trial

Important dates

Study start: 2002
Primary completion: 2004
Study completion: 2004
First posted: Aug 21, 2002
Registry last updated: Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed