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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00044148
Recruitment Status : Completed
First Posted : August 21, 2002
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Chromaderm, Inc.

Tracking Information
First Submitted Date  ICMJE August 20, 2002
First Posted Date  ICMJE August 21, 2002
Last Update Posted Date February 1, 2017
Actual Study Start Date  ICMJE July 16, 2002
Actual Primary Completion Date April 28, 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00044148 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of LY333531 on Protein in the Urine in Patients With Type 2 Diabetes
Official Title  ICMJE The Effect of LY333531 on Albuminuria in Patients With Type 2 Diabetes A Pilot Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Diabetic Nephropathy
Intervention  ICMJE Drug: LY333531
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date April 28, 2004
Actual Primary Completion Date April 28, 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00044148
Other Study ID Numbers  ICMJE 6249
B7A-MC-MBDA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Chromaderm, Inc.
Study Sponsor  ICMJE Chromaderm, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chromaderm, Inc.
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP