NCT00622089

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2 type-2-diabetes

Geographic Reach
3 countries

24 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 28, 2008

Status Verified

May 1, 2008

Enrollment Period

11 months

First QC Date

January 3, 2008

Last Update Submit

May 22, 2008

Conditions

Type 2 Diabetes

Keywords

diabetestype 2 diabetescholesterol

Outcome Measures

Primary Outcomes (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

    24 weeks

Study Arms (3)

1

EXPERIMENTAL

150mg DIO-902 + 10mg Atorvastatin

Drug: DIO-902

2.

EXPERIMENTAL

300mg DIO-902 + 10mg Atorvastatin

Drug: DIO-902

3

EXPERIMENTAL

450mg DIO-902 + 10mg Atorvastatin

Drug: DIO-902

Interventions

DIO-902DRUG

150mg DIO-902 + 10mg atorvastatin

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participated in DIO-502

You may not qualify if:

  • Did not participate in DIO-502

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Dr. Terence Hart

Muscle Shoals, Alabama, 35662, United States

Location

Genova Research

Tucson, Arizona, 85741, United States

Location

Research Solutions

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Primary Care Clinic

Little Rock, Arkansas, 72211, United States

Location

Advanced Medical Research

Lakewood, California, 90712, United States

Location

Mills-Peninsula Helath Services

San Mateo, California, 94401, United States

Location

Diabetes Research Goup University of Hawaii at Manoa

Honolulu, Hawaii, 96813, United States

Location

Creighton Diabetes Center

Omaha, Nebraska, 68131, United States

Location

AHS Oklahoma Physician Group

Tulsa, Oklahoma, 74104, United States

Location

Covance Clinical Research Unit - Dr. Andrew Ahmann

Portland, Oregon, 927239, United States

Location

Covance CRU

Austin, Texas, 78752, United States

Location

Diabetes Glandular Disease Research Associates

San Antonio, Texas, 78229, United States

Location

Flinders Medical Centre

Adelaide, South Australia, Australia

Location

Lyell McEwin Hospital

North Western Adelaide, South Australia, Australia

Location

ECRU

Box Hill, Melbourne, Victoria, Australia

Location

School of Medicine and Pharmacology

Fremantle, Western Australia, 6160, Australia

Location

Keough Institute

Nedands, Western Australia, 6009, Australia

Location

Endocrinology Research Unit

Herston Road, QLD 4029, Australia

Location

Endocrinology Department

St Leonards, NSW 2065, Australia

Location

Royal Melbourn Hospital

Victoria, Australia

Location

Middlemore Hospital

Otahuhu, Auckland, New Zealand

Location

Lipid and Diabetes Research

Christchurch, New Zealand

Location

Waikaito Hospital

Hamilton, New Zealand

Location

Diabetes Centre

Wellington, New Zealand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 3, 2008

First Posted

February 22, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 28, 2008

Record last verified: 2008-05

Locations

US(12)AU(8)NZ(4)