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Multiple Dose Trial of Anti-glycation Agent GLY-230 in Healthy and Diabetic Subjects

This study has been completed.
Sponsor:
Information provided by:
Glycadia
ClinicalTrials.gov Identifier:
NCT00544934
First received: October 15, 2007
Last updated: February 9, 2016
Last verified: February 2016
  Purpose
A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects

Condition Intervention Phase
Diabetic Nephropathy Drug: GLY-230 Other: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: A Dose-ranging Study to Evaluate the Safety, Metabolism and Therapeutic Dosing of Three Multiple Dose Levels of GLY-230 in Healthy and Diabetic Subjects

Resource links provided by NLM:


Further study details as provided by Glycadia:

Primary Outcome Measures:
  • glycated albumimin concentration [ Time Frame: three weeks ]

Secondary Outcome Measures:
  • urine albumin [ Time Frame: three weeks ]

Enrollment: 42
Study Start Date: February 2007
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: 250 mg Drug: GLY-230
125, 250 0r 375 mg bid for 14 days
Experimental: 500 mg Drug: GLY-230
125, 250 0r 375 mg bid for 14 days
Experimental: 750 mg Drug: GLY-230
125, 250 0r 375 mg bid for 14 days
Placebo Comparator: Placebo Other: Placebo
No drug administered

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nondiabetic and diabetic men age 18-55, engative drug screen, normal EKG, clinical chemistries. hematology parameters, HbA1c 7.5% if diabetic, give written informed consent

Exclusion Criteria:

  • Sctive concomitant serious medical or surgical disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544934

Sponsors and Collaborators
Glycadia
Investigators
Principal Investigator: Laurence Kennedy, M.D. University of Florida
Principal Investigator: Maria del Pilar Solano, M.D. University of Miami, Miami, Florida
Principal Investigator: Lis Cohen, D.O. Suncoast Clinical Research, New Port Richey, Florida
  More Information

ClinicalTrials.gov Identifier: NCT00544934     History of Changes
Other Study ID Numbers: GLY-002
Study First Received: October 15, 2007
Last Updated: February 9, 2016

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 16, 2017