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

NCT ID: NCT00622089

Last Updated: 2008-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes

Keywords

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diabetes type 2 diabetes cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

150mg DIO-902 + 10mg Atorvastatin

Group Type EXPERIMENTAL

DIO-902

Intervention Type DRUG

150mg DIO-902 + 10mg atorvastatin

2.

300mg DIO-902 + 10mg Atorvastatin

Group Type EXPERIMENTAL

DIO-902

Intervention Type DRUG

300mg dose once per day for 24 weeks

3

450mg DIO-902 + 10mg Atorvastatin

Group Type EXPERIMENTAL

DIO-902

Intervention Type DRUG

450mg dose once per day for 24 weeks

Interventions

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DIO-902

150mg DIO-902 + 10mg atorvastatin

Intervention Type DRUG

DIO-902

300mg dose once per day for 24 weeks

Intervention Type DRUG

DIO-902

450mg dose once per day for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participated in DIO-502

Exclusion Criteria

* Did not participate in DIO-502
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DiObex

INDUSTRY

Sponsor Role lead

Responsible Party

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DiObex, Inc.

Locations

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Dr. Terence Hart

Muscle Shoals, Alabama, United States

Site Status

Genova Research

Tucson, Arizona, United States

Site Status

Research Solutions

Jonesboro, Arkansas, United States

Site Status

Arkansas Primary Care Clinic

Little Rock, Arkansas, United States

Site Status

Advanced Medical Research

Lakewood, California, United States

Site Status

Mills-Peninsula Helath Services

San Mateo, California, United States

Site Status

Diabetes Research Goup University of Hawaii at Manoa

Honolulu, Hawaii, United States

Site Status

Creighton Diabetes Center

Omaha, Nebraska, United States

Site Status

AHS Oklahoma Physician Group

Tulsa, Oklahoma, United States

Site Status

Covance Clinical Research Unit - Dr. Andrew Ahmann

Portland, Oregon, United States

Site Status

Covance CRU

Austin, Texas, United States

Site Status

Diabetes Glandular Disease Research Associates

San Antonio, Texas, United States

Site Status

Flinders Medical Centre

Adelaide, South Australia, Australia

Site Status

Lyell McEwin Hospital

North Western Adelaide, South Australia, Australia

Site Status

ECRU

Box Hill, Melbourne, Victoria, Australia

Site Status

School of Medicine and Pharmacology

Fremantle, Western Australia, Australia

Site Status

Keough Institute

Nedands, Western Australia, Australia

Site Status

Endocrinology Research Unit

Herston Road, , Australia

Site Status

Endocrinology Department

St Leonards, , Australia

Site Status

Royal Melbourn Hospital

Victoria, , Australia

Site Status

Middlemore Hospital

Otahuhu, Auckland, New Zealand

Site Status

Lipid and Diabetes Research

Christchurch, , New Zealand

Site Status

Waikaito Hospital

Hamilton, , New Zealand

Site Status

Diabetes Centre

Wellington, , New Zealand

Site Status

Countries

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United States Australia New Zealand

Other Identifiers

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DIO-503

Identifier Type: -

Identifier Source: org_study_id