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Sponsored by: |
DiObex |
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Information provided by: | DiObex |
ClinicalTrials.gov Identifier: | NCT00302224 |
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.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes |
Drug: 2S, 4R Ketoconazole (DIO-902) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase 1/2a, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Study of Safety, Tolerability, Pharmacokinetics and Activity of 14 Days of Oral Dosing With the 2S,4R Enantiomer of Ketoconazole (DIO-902) in Subjects With Type 2 Diabetes Mellitus |
Estimated Enrollment: | 50 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | August 2006 |
DiObex is developing a modified form of ketoconazole (enantiomer) (DIO-902) as an investigational new drug for the treatment of the elevated blood sugar associated with type 2 diabetes. Other benefits may include reduced total and LDL cholesterol, and reduced blood pressure. With chronic treatment, reduced visceral fat may also be seen. Ketoconazole (racemic) is an approved drug for the treatment of a variety of fungal infections. The approved racemic ketoconazole inhibits cortisol synthesis. In patients with Cushings Disease racemic ketoconazole reduces glucose, cholesterol and blood pressure. Elevated cortisol may be a contributing causal factor in the development of type 2 diabetes; clinical trials with racemic ketoconazole have been carried out in these patients. The results of these clinical trials support the concept of treating type 2 diabetes through a lowering of plasma cortisol and provide evidence of the safety and tolerability of racemic ketoconazole. Racemic ketoconazole has, however, been associated with liver toxicity which is generally mild in nature. However, in rare cases (1:10,000 to 15,000 patients) severe liver toxicity may occur, and in extremely rare cases this adverse event may be irreversible and life-threatening. Preclinical results suggest that DIO-902 may be both safer and more efficacious than the racemic mixture.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
9.12-lead electrocardiogram (ECG) shows no acute ischemia or clinically significant abnormality
10.BMI of 26 to 40 kg/m2
11.Subjects with a history of hypertension may be on a stable anti-hypertensive regimen (except those drugs stated under Exclusion Criterion 7) for > 2 months
12.Ability to comprehend and a willingness to provide informed consent
Exclusion Criteria:
United States, District of Columbia | |
Asha Thomas, MD - Medstar | |
Washington DC, District of Columbia, United States, 20003 | |
United States, Nebraska | |
Marc Rendell, MD - Creighton University | |
Omaha, Nebraska, United States, 68131 | |
United States, Oregon | |
Dr. Andrew Ahmann, MD - Radiant Research | |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
Carlos Arauz-Pacheco, MD - Radiant Research | |
Dallas, Texas, United States, 75247 | |
Sherwin Schwartz, MD - Diabetes and Glandular Disease Clinic | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Sherwin Schwartz, MD | Diabetes and Glandular Disease Clinic |
Study ID Numbers: | DIO-501 |
Study First Received: | March 10, 2006 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00302224 |
Health Authority: | United States: Food and Drug Administration |
safety type 2 diabetes |
Metabolic Diseases Clotrimazole Miconazole Diabetes Mellitus, Type 2 Tioconazole Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Ketoconazole Metabolic disorder Glucose Metabolism Disorders |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Pharmacologic Actions |