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

Diabetic Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544934
• Other study ID #: GLY-002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 15, 2007
• Last updated: February 9, 2016
• Start date: February 2007
• Est. completion date: October 2007

Study information

• Verified date: February 2016
• Source: Glycadia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy

Intervention

Drug:
• GLY-230
125, 250 0r 375 mg bid for 14 days

Other:
• Placebo
No drug administered

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Glycadia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycated albumimin concentration		three weeks
Secondary	urine albumin		three weeks