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Development of A Novel Anti-Hyperglycemic Agent

NCT00878605 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-06-14

Study results available
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Summary

The purpose of this clinical trial is to test the effectiveness and safety of a new anti-diabetes drug (Cyclo-Z) for the prevention and treatment of Type 2 diabetes. This study will determine dose-dependent efficacy and safety of this new drug for the treatment of human diabetes. The Food and Drug Administration has granted approval for the use of this investigational product to be used in a study \[FDA approval (Investigational New Drug) IND #: 61,897\]. This new drug is thought to work by increasing the amount of zinc in your body, which in turn should improve your sugar metabolism. If this study successfully proves that Cyclo-Z is effective for the treatment of diabetes and is without significant side effects, a large, multi-center study of diabetic patients will then be performed.

Conditions

Interventions

DRUG

Cyclo-Z

Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose

DRUG

Placebo

Placebo control

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Zhaoping Li, MD · VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-01
Primary Completion
2013-06-01
Completion
2013-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00878605 on ClinicalTrials.gov