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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00544934

Enrollment

Registered

2007-10-16

Start date

2007-02-28

Completion date

2007-10-31

Last updated

2016-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Brief summary

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

Interventions

DRUGGLY-230

125, 250 0r 375 mg bid for 14 days

OTHERPlacebo

No drug administered

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
glycated albumimin concentration	three weeks

Secondary

Measure	Time frame
urine albumin	three weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026