drugset / Trial / NCT00302224

A Phase 1/2a Study of the 2S,4R Enantiomer of Ketoconazole in Subjects With Type 2 Diabetes Mellitus

NCT00302224 ↗

Phase 1/2 Completed 50 enrolled DiObex
RandomizedParallel-groupDouble-blindTreatment

Summary

The study is designed to test the safety, tolerability of a newly developed form of ketoconazole (DIO-902) for the treatment of elevated blood sugars in type 2 diabetes. This study also will also examine the effect of the drug on total and LDL cholesterol and blood pressure. Elevated cortisol may contribute to the development of Type II diabetes. The investigational drug DIO-902 may reduce the level of cortisol in blood and therefore provide better control of blood sugar levels in patients with Type II diabetes.

Timeline

Start
2005-02
Primary completion
—
Completion
2006-08

Drugs

EvaluationDrugModalityDoseRoute
Subject 2S, 4R Ketoconazole Unknown — Oral