drugset / Trial / NCT00878605

Development of A Novel Anti-Hyperglycemic Agent

NCT00878605

Phase 2 Terminated 38 enrolled VA Office of Research and Development
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2010-04-01
Primary completion
2013-06-01
Completion
2013-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclo-His Pro Peptide 3 mg
Subject Cyclo-His Pro Peptide 9 mg
Subject Cyclo-His Pro Peptide 15 mg
Subject Zinc Sulfate Unknown 20 mg