NCT00044148

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2002

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 20, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2002

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2004

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

August 20, 2002

Last Update Submit

January 30, 2017

Conditions

Diabetic Nephropathy

Keywords

Persistent Albuminuria

Interventions

LY333531DRUG

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

Walnut Creek, California, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Waltham, Massachusetts, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Greenville, North Carolina, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

ruboxistaurin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2002

First Posted

August 21, 2002

Study Start

July 16, 2002

Primary Completion

April 28, 2004

Study Completion

April 28, 2004

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

US(15)