Open Label Safety & Pharmacodynamic Study 24Wk w/DIO-902 Combo w/Metformin & Atorvastatin in T2DM Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00622089
Recruitment Status : Terminated (Program terminated)
First Posted : February 22, 2008
Last Update Posted : May 28, 2008
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: DIO-902 Phase 2 Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : January 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The following parameters will be evaluated at Week 12 and Week 24: • Proportion of subjects who reach the lipid goal as defined in the protocol from baseline • Proportion of subjects who meet the HbA1c goal as defined in the protocol from baseline [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participated in DIO-502

Exclusion Criteria:

  • Did not participate in DIO-502

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00622089

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Sponsors and Collaborators

Responsible Party: Bernice Welles, MD, DiObex, Inc. Identifier: NCT00622089     History of Changes
Other Study ID Numbers: DIO-503
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: May 28, 2008
Last Verified: May 2008

Keywords provided by DiObex:
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atorvastatin Calcium
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors