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Sponsored by: |
DiObex |
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Information provided by: | DiObex |
ClinicalTrials.gov Identifier: | NCT00622089 |
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 |
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Type 2 Diabetes |
Drug: DIO-902 |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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1: Experimental
150mg DIO-902 + 10mg Atorvastatin
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Drug: DIO-902
150mg DIO-902 + 10mg atorvastatin
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2.: Experimental
300mg DIO-902 + 10mg Atorvastatin
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Drug: DIO-902
300mg dose once per day for 24 weeks
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3: Experimental
450mg DIO-902 + 10mg Atorvastatin
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Drug: DIO-902
450mg dose once per day for 24 weeks
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | DiObex, Inc. ( Bernice Welles, MD ) |
Study ID Numbers: | DIO-503 |
Study First Received: | January 3, 2008 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00622089 History of Changes |
Health Authority: | United States: Food and Drug Administration; Australia: Therapeutic Goods Administration; New Zealand: Medsafe |
diabetes type 2 diabetes cholesterol |
Antimetabolites Metabolic Diseases Antilipemic Agents Metformin Diabetes Mellitus Endocrine System Diseases Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Atorvastatin |
Antimetabolites Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Atorvastatin |