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| Sponsor: | DiObex |
|---|---|
| Information provided by: | DiObex |
| ClinicalTrials.gov Identifier: | NCT00622089 |
Purpose
DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the ketoconazole molecule for the treatment of elevated blood glucose associated with type 2 diabetes mellitus. Ketoconazole (Nizoral®) is a drug available by prescription for the treatment of fungal infections however DIO-902 is an investigational drug. DIO-902 may lower blood glucose by lowering levels of a naturally occurring hormone called cortisol. Elevated cortisol may contribute to the development of type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: DIO-902 |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Follow-On Study of Safety and Pharmacodynamic Effects of 24 Weeks of Treatment With DIO-902 in Combination With Metformin and Atorvastatin in Subjects With Type 2 Diabetes Mellitus (Protocol No. DIO-503) |
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
150mg DIO-902 + 10mg Atorvastatin
|
Drug: DIO-902
150mg DIO-902 + 10mg atorvastatin
|
|
Experimental: 2.
300mg DIO-902 + 10mg Atorvastatin
|
Drug: DIO-902
300mg dose once per day for 24 weeks
|
|
Experimental: 3
450mg DIO-902 + 10mg Atorvastatin
|
Drug: DIO-902
450mg dose once per day for 24 weeks
|
To maintain the blind in Protocol DIO-502, subjects will be re-randomized at Study Visit 1 to one of three doses of DIO-902: 150, 300 or 450 mg QHS. All subjects receiving DIO-902 placebo and 50% of subjects receiving DIO-902 will be re-randomized to one of three DIO-902 doses. The remaining 50% of subjects receiving DIO-902 will be assigned to their original DIO-902 dose. The re- randomization will be performed by a group independent of study conduct to ensure the treatment status of the subject while in Protocol DIO-502 remains blinded. In addition, subjects will continue on the same dose of metformin that they had been taking during the conduct of Protocol DIO-502. Subjects will continue on atorvastatin 10 mg for the first 4 weeks of this protocol. Thereafter, at Study Visits 3 and 4, the dose of atorvastatin may be increased up to a maximum of 40 mg daily in order to achieve LDL-cholesterol/non-HDL cholesterol goals specified within the protocol. In addition, after Study Visit 4 (Week 12) subjects with HbA1c levels of > 7.5% (0.075 Hb Fract.) will undergo a one time titration of their oral hypoglycemic regimen as per the algorithm provided in the protocol.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 24 Study Locations
More Information
| Responsible Party: | Bernice Welles, MD, DiObex, Inc. |
| ClinicalTrials.gov Identifier: | NCT00622089 History of Changes |
| Other Study ID Numbers: | DIO-503 |
| Study First Received: | January 3, 2008 |
| Last Updated: | May 22, 2008 |
| Health Authority: | United States: Food and Drug Administration Australia: Therapeutic Goods Administration New Zealand: Medsafe |
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diabetes type 2 diabetes cholesterol |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Atorvastatin Hypoglycemic Agents Physiological Effects of Drugs |
Pharmacologic Actions Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |