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CompletedNCT00544934Updated Feb 10, 2016

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

A Phase 1/2 interventional study of GLY-230 and Placebo in Diabetic Nephropathy, sponsored by Glycadia. Completed. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-10.

Sponsored by Glycadia · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Diabetic Nephropathy
03

In context

Diabetic Nephropathies

534 studies on the registry are indexed under Diabetic Nephropathies; 107 are open to participants now.

This study's enrollment of 42 is below the median of 80 across 377 interventional studies indexed under Diabetic Nephropathies.

Browse Diabetic Nephropathies studies →

Lead sponsor

Glycadia is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

Exclusion Criteria:

  • Sctive concomitant serious medical or surgical disease
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    250 mg

    Drug: GLY-230

  • Experimental
    500 mg

    Drug: GLY-230

  • Experimental
    750 mg

    Drug: GLY-230

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • DrugGLY-230

    125, 250 0r 375 mg bid for 14 days

  • OtherPlacebo

    No drug administered

06

What researchers measure

Primary outcomes

  1. glycated albumimin concentration

    Time frame: three weeks

Secondary outcomes

  1. urine albumin

    Time frame: three weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00544934
Lead sponsor
Glycadia
First posted
Oct 16, 2007
Start date
Feb 2007
Completion
Oct 2007
Last update
Feb 10, 2016

Study contacts

Laurence Kennedy, M.D.
principal investigator · University of Florida
Maria del Pilar Solano, M.D.
principal investigator · University of Miami, Miami, Florida
Lis Cohen, D.O.
principal investigator · Suncoast Clinical Research, New Port Richey, Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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