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

Diabetic Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044148
• Other study ID #: 6249
• Secondary ID: B7A-MC-MBDA
• Status: Completed
• Phase: Phase 2
• First received: August 20, 2002
• Last updated: January 30, 2017
• Start date: July 16, 2002
• Est. completion date: April 28, 2004

Study information

• Verified date: January 2017
• Source: Chromaderm, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 28, 2004
• Est. primary completion date: April 28, 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy

Intervention

Drug:
• LY333531

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chromaderm, Inc.

Country where clinical trial is conducted

United States,