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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2008
Actual
Sample size
Target
150
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/ct2/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/ct2/show/NCT00622089