Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00302224
Status:
COMPLETED
Last Update Posted:
2008-02-22
First Post:
2006-03-10
Brief Title:
A Phase 12a Study of the 2S4R Enantiomer of Ketoconazole in Subjects With Type 2 Diabetes Mellitus
Sponsor:
DiObex
Organization:
DiObex
Study Overview
Official Title:
A Phase 12a Randomized Placebo-Controlled Double-Blind Parallel-Group Study of Safety Tolerability Pharmacokinetics and Activity of 14 Days of Oral Dosing With the 2S4R Enantiomer of Ketoconazole DIO-902 in Subjects With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 110000 to 15000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None