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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00622089




Registration number
NCT00622089
Ethics application status
Date submitted
3/01/2008
Date registered
22/02/2008
Date last updated
28/05/2008

Titles & IDs
Public title
Open Label Safety & Pharmacodynamic Study 24Wk w/DIO-902 Combo w/Metformin & Atorvastatin in T2DM Patients
Scientific 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)
Secondary ID [1] 0 0
DIO-503
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DIO-902
Treatment: Drugs - DIO-902
Treatment: Drugs - DIO-902

Experimental: 1 - 150mg DIO-902 + 10mg Atorvastatin

Experimental: 2. - 300mg DIO-902 + 10mg Atorvastatin

Experimental: 3 - 450mg DIO-902 + 10mg Atorvastatin


Treatment: Drugs: DIO-902
150mg DIO-902 + 10mg atorvastatin

Treatment: Drugs: DIO-902
300mg dose once per day for 24 weeks

Treatment: Drugs: DIO-902
450mg dose once per day for 24 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
24 weeks

Eligibility
Key inclusion criteria
- Participated in DIO-502
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Did not participate in DIO-502

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Lyell McEwin Hospital - North Western Adelaide
Recruitment hospital [3] 0 0
ECRU - Box Hill, Melbourne
Recruitment hospital [4] 0 0
School of Medicine and Pharmacology - Fremantle
Recruitment hospital [5] 0 0
Keough Institute - Nedands
Recruitment hospital [6] 0 0
Endocrinology Research Unit - Herston Road
Recruitment hospital [7] 0 0
Endocrinology Department - St Leonards
Recruitment hospital [8] 0 0
Royal Melbourn Hospital - Victoria
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- North Western Adelaide
Recruitment postcode(s) [3] 0 0
- Box Hill, Melbourne
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment postcode(s) [5] 0 0
6009 - Nedands
Recruitment postcode(s) [6] 0 0
QLD 4029 - Herston Road
Recruitment postcode(s) [7] 0 0
NSW 2065 - St Leonards
Recruitment postcode(s) [8] 0 0
- Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
New Zealand
State/province [11] 0 0
Christchurch
Country [12] 0 0
New Zealand
State/province [12] 0 0
Hamilton
Country [13] 0 0
New Zealand
State/province [13] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
DiObex
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00622089
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00622089