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Trial registered on ANZCTR


Registration number
ACTRN12612000261819
Ethics application status
Approved
Date submitted
24/02/2012
Date registered
2/03/2012
Date last updated
28/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot Study of the Effects of GC811007 Administration on Copper and Trace Metal Metabolism in Non-diabetic Subjects and Patients with Type 2 Diabetes Mellitus: A Dose-response Sub-study
Scientific title
Pilot Study of the Effects of GC811007 Administration on Copper and Trace Metal Metabolism in Non-diabetic Subjects and Patients with Type 2 Diabetes Mellitus: A Dose-response Sub-study of TETA on urinary copper excretion
Secondary ID [1] 279948 0
Nil
Universal Trial Number (UTN)
Trial acronym
TRACE-Dose Rising study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type-2 Diabetes Mellitus 285864 0
Condition category
Condition code
Metabolic and Endocrine 286049 286049 0 0
Diabetes
Metabolic and Endocrine 286050 286050 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was an open-label, sequential, escalating, dose-response study in which 14 adult males (7 diabetic and 7 non-diabetic subjects) were assessed. Four escalating doses (300, 600, 1200, and 2400 mg) of GC811007 taken as 300mg capsules, were administered to each subject daily; each dose was taken once-daily before breakfast for 7 days, with a 6-week washout period between each dose; 24-h urine collections at baseline and on the final day of each dosing period, were performed to measure trace element excretion.
Intervention code [1] 284278 0
Treatment: Drugs
Comparator / control treatment
Dose comparison of diabetic versus healthy particpants. All participants receive all doses.
Control group
Dose comparison

Outcomes
Primary outcome [1] 286573 0
Effect of 4 escalating doses of GC811007 on Urinary Copper excretion over 24 hrs, on Day 1 and Day 7 of each treatment week.
Timepoint [1] 286573 0
urine copper excretion collected over 24 hrs, on Day 1 and Day 7 of each treatment week.
Secondary outcome [1] 296203 0
Effect of 4 escalating doses of GC811007 on Urinary Zinc and Iron excretion over 24 hrs, on Day 1 and Day 7 of each treatment week.
Timepoint [1] 296203 0
Urine metal excretion collected over 24 hrs, on Day 1 and Day 7 of each treatment week.

Eligibility
Key inclusion criteria
Patients with type-2 diabetes mellitus and healthy non-diabetic subjects with normal glucose tolerance; normal ECG; normal serum levels of Fe and ferritin
Minimum age
No limit
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects who had not participated in a previous 12-day residential study of trace metal balance; eligible subjects who did not have normal glucose tolerance and ECG and normal levels of serum Fe and Ferritin

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 4135 0
New Zealand
State/province [1] 4135 0

Funding & Sponsors
Funding source category [1] 284758 0
Commercial sector/Industry
Name [1] 284758 0
Protemix Corporation
Address [1] 284758 0
Protemix Corporation Ltd.
PO Box 2165, Shortland Street
Auckland 1140
Country [1] 284758 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Protemix Corporation Ltd.
Address
PO Box 2165, Shortland Street
Auckland 1140
Country
New Zealand
Secondary sponsor category [1] 283650 0
None
Name [1] 283650 0
Address [1] 283650 0
Country [1] 283650 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286776 0
Auckland Health & Disabilities Ethics Committee
Ethics committee address [1] 286776 0
Ethics committee country [1] 286776 0
New Zealand
Date submitted for ethics approval [1] 286776 0
Approval date [1] 286776 0
Ethics approval number [1] 286776 0
2001/026

Summary
Brief summary
The study was designed to explore the dose-rising effects of GC811007 on trace metal metabolism in patients with T2DM and healthy non-diabetic subjects; specifically we wanted to investigate the effects of 4 doses of GC811007 on trace metal urine excretion over a period of 7 days. We hypothesised that increasing doses of GC811007 would increase urine copper losses in a dose-dependent manner
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33781 0
Address 33781 0
Country 33781 0
Phone 33781 0
Fax 33781 0
Email 33781 0
Contact person for public queries
Name 17028 0
Dr Sally Poppitt
Address 17028 0
School of Biological Sciences
University of Auckland
Private Bag 92 019
Auckland 1142
Country 17028 0
New Zealand
Phone 17028 0
+64 (9) 630 5160
Fax 17028 0
Email 17028 0
s.poppitt@auckland.ac.nz
Contact person for scientific queries
Name 7956 0
Dr Garth Cooper
Address 7956 0
School of Biological Sciences
University of Auckland
Private Bag 92 019
Auckland 1142
Country 7956 0
New Zealand
Phone 7956 0
+64 (9) 923 7239
Fax 7956 0
Email 7956 0
g.cooper@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary