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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00544934
First Posted: October 16, 2007
Last Update Posted: February 10, 2016
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.
Information provided by:
Glycadia
  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 (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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: October 15, 2007
First Posted: October 16, 2007
Last Update Posted: February 10, 2016
Last Verified: February 2016

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