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

May 22, 2008 updated by: DiObex

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Herston Road, Australia, QLD 4029
        • Endocrinology Research Unit
      • St Leonards, Australia, NSW 2065
        • Endocrinology Department
      • Victoria, Australia
        • Royal Melbourn Hospital
    • South Australia
      • Adelaide, South Australia, Australia
        • Flinders Medical Centre
      • North Western Adelaide, South Australia, Australia
        • Lyell McEwin Hospital
    • Victoria
      • Box Hill, Melbourne, Victoria, Australia
        • ECRU
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • School of Medicine and Pharmacology
      • Nedands, Western Australia, Australia, 6009
        • Keough Institute
  • New Zealand
      • Christchurch, New Zealand
        • Lipid and Diabetes Research
      • Hamilton, New Zealand
        • Waikaito Hospital
      • Wellington, New Zealand
        • Diabetes Centre
    • Auckland
      • Otahuhu, Auckland, New Zealand
        • Middlemore Hospital
  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35662
        • Dr. Terence Hart
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Genova Research
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Research Solutions
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Primary Care Clinic
    • California
      • Lakewood, California, United States, 90712
        • Advanced Medical Research
      • San Mateo, California, United States, 94401
        • Mills-Peninsula Helath Services
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Diabetes Research Goup University of Hawaii at Manoa
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton Diabetes Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • AHS Oklahoma Physician Group
    • Oregon
      • Portland, Oregon, United States, 927239
        • Covance Clinical Research Unit - Dr. Andrew Ahmann
    • Texas
      • Austin, Texas, United States, 78752
        • Covance CRU
      • San Antonio, Texas, United States, 78229
        • Diabetes Glandular Disease Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participated in DIO-502

Exclusion Criteria:

  • Did not participate in DIO-502

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
150mg DIO-902 + 10mg Atorvastatin
Drug: DIO-902
150mg DIO-902 + 10mg atorvastatin
Drug: DIO-902
300mg dose once per day for 24 weeks
Drug: DIO-902
450mg dose once per day for 24 weeks
Experimental: 2.
300mg DIO-902 + 10mg Atorvastatin
Drug: DIO-902
150mg DIO-902 + 10mg atorvastatin
Drug: DIO-902
300mg dose once per day for 24 weeks
Drug: DIO-902
450mg dose once per day for 24 weeks
Experimental: 3
450mg DIO-902 + 10mg Atorvastatin
Drug: DIO-902
150mg DIO-902 + 10mg atorvastatin
Drug: DIO-902
300mg dose once per day for 24 weeks
Drug: DIO-902
450mg dose once per day for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DiObex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2008

Last Update Submitted That Met QC Criteria

May 22, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIO-503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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