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

This study has been terminated.
(Program terminated)
Sponsor:
Information provided by:
DiObex
ClinicalTrials.gov Identifier:
NCT00622089
First received: January 3, 2008
Last updated: May 22, 2008
Last verified: May 2008
  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)

Resource links provided by NLM:


Further study details as provided by DiObex:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participated in DIO-502

Exclusion Criteria:

  • Did not participate in DIO-502
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622089

  Show 24 Study Locations
Sponsors and Collaborators
DiObex
  More Information

No publications provided

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

Keywords provided by DiObex:
diabetes
type 2 diabetes
cholesterol

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 17, 2014