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Clinical Trials/NCT00544934
NCT00544934
Completed
Phase 1

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

Glycadia0 sites42 target enrollmentFebruary 2007
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ConditionsDiabetic Nephropathy
InterventionsGLY-230Placebo

Overview

Phase
Phase 1
Intervention
GLY-230
Conditions
Diabetic Nephropathy
Sponsor
Glycadia
Enrollment
42
Primary Endpoint
glycated albumimin concentration
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
February 2007
End Date
October 2007
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Glycadia

Eligibility 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

Arms & Interventions

250 mg

Intervention: GLY-230

500 mg

Intervention: GLY-230

750 mg

Intervention: GLY-230

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

glycated albumimin concentration

Time Frame: three weeks

Secondary Outcomes

  • urine albumin(three weeks)

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