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

This study has been completed.
Information provided by:
Glycadia Identifier:
First received: October 15, 2007
Last updated: March 10, 2015
Last verified: March 2015
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
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

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


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00544934

Sponsors and Collaborators
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

No publications provided Identifier: NCT00544934     History of Changes
Other Study ID Numbers: GLY-002 
Study First Received: October 15, 2007
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Nephropathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Kidney Diseases
Urologic Diseases processed this record on February 04, 2016