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Trial registered on ANZCTR


Registration number
ACTRN12612000293864
Ethics application status
Approved
Date submitted
24/02/2012
Date registered
13/03/2012
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
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 randomized, double-blind, placebo-controlled trial in adult males with Type 2 diabetes mellitus and non-diabetic subjects to measure the effects on urinary copper, zinc and iron excretion.
Secondary ID [1] 280004 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 285913 0
Condition category
Condition code
Metabolic and Endocrine 286103 286103 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was a randomized, double-blind, placebo-controlled trial in adult males with Type 2 diabetes mellitus and non-diabetic subjects; the two groups were age-matched. Within each group, half received GC811007 2400 mg/day taken once daily for the six day treatment period before breakfast, supplied as 300-mg capsules; and half received placebo. After the screening visit, subjects resided at the study site for a 6-day baseline period and a 6-day treatment period, during which all food and beverages were provided and measured to control intake of dietary Cu and other trace metals.
Intervention code [1] 284329 0
Treatment: Drugs
Comparator / control treatment
Placebo was supplied as microcrystalline cellulose (Vivapur type 102) in opaque Capsugel gelatin capsules
Control group
Placebo

Outcomes
Primary outcome [1] 286579 0
change in urine Cu excretion as measured from:
- 24-h urine collections throughout the baseline (diet only, Days 1-6) and treatment periods (GC811007 or placebo, Days 7-12)
Timepoint [1] 286579 0
Days 1-6 - baseline measurements;
Days 7-12 - treatment periods
Primary outcome [2] 286580 0
change in urine Cu excretion as measured from:
- 2-h urine collections during the first 10-h of the baseline (Diet only, Day 1) and treatment (GC811007 or placebo, Day 7) periods
Timepoint [2] 286580 0
Day 1 and Day 7
Primary outcome [3] 286581 0
change in Cu excretion as measured from:
24-h fecal collections throughout the baseline (Diet only, Days 2-7) and treatment periods (GC811007 or placebo, Days 8-13)
Timepoint [3] 286581 0
Baseline at Days 2-7
Days 8-13 post-treatment
Secondary outcome [1] 296210 0
Cumulative Cu excretion by both urine and fecal collections.
Timepoint [1] 296210 0
Daily measurements for 6 days (Diet only, days 1-6 = pretreatment)
Days 7-12 Treatment periods (GC811007 or placebo)
Secondary outcome [2] 296211 0
Dietary copper intake compared with urine and fecal excretion
Timepoint [2] 296211 0
Daily measurements for 6 days (Diet only, days 1-6 = pretreatment)
Days 7-12 Treatment periods (GC811007 or placebo)
Secondary outcome [3] 296212 0
Circulating serum Mg levels
Timepoint [3] 296212 0
Daily measurements for 6 days (Diet only, days 1-6 = pretreatment)
Days 7-12 Treatment periods (GC811007 or placebo)
Secondary outcome [4] 296213 0
Trace metal excretion = both urine and fecal excretion
Balance = intake compared with urine and fecal excretion
Timepoint [4] 296213 0
Daily measurements for 6 days (Diet only, days 1-6 = pretreatment)
Days 7-12 Treatment periods (GC811007 or placebo)

Eligibility
Key inclusion criteria
Male patients with Type 2 diabetes, and non-diabetic healthy male subjects with normal glucose tolerance test; normal ECG; normal serum levels of iron and ferritin; willingness to participate in a residential study for 12 days
Minimum age
No limit
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Female Gender, abnormal GTT; abnormal ECG; Abnormal serum iron and ferritin; unable to participate in a 12 day residential study.

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
Blinded (masking 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] 4164 0
New Zealand
State/province [1] 4164 0

Funding & Sponsors
Funding source category [1] 284764 0
Commercial sector/Industry
Name [1] 284764 0
Protemix Corporation
Address [1] 284764 0
Protemix Corporation Ltd.
PO Box 2165, Shortland Street
Auckland 1140
Country [1] 284764 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Protemix Corporation
Address
Protemix Corporation Ltd.
PO Box 2165, Shortland Street
Auckland 1140
Country
New Zealand
Secondary sponsor category [1] 283654 0
None
Name [1] 283654 0
Address [1] 283654 0
Country [1] 283654 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286775 0
Auckland Health & Disabilities Ethics Committee
Ethics committee address [1] 286775 0
Ethics committee country [1] 286775 0
New Zealand
Date submitted for ethics approval [1] 286775 0
Approval date [1] 286775 0
Ethics approval number [1] 286775 0
2001/026

Summary
Brief summary
The study was designed to explore the effects of GC811007 on trace metal metabolism in patients with T2DM and healthy non-diabetic subjects; specifically we wanted to investigate the effects of GC811007 on trace metal urine and fecal excretion under carefully controlled dietarty conditions in order to calculate trace element balance over a period of 6 days. We hypothesised firstly that baseline urine copper excretion would be raised in T2DM indicative of raised whole-body copper status which is a pro-oxidant status, and secondly that treatment with GC811007 would increase urine and fecal copper losses, and engender a negative copper balance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33820 0
Address 33820 0
Country 33820 0
Phone 33820 0
Fax 33820 0
Email 33820 0
Contact person for public queries
Name 17067 0
Dr Sally Poppitt
Address 17067 0
School of Biological Sciences
University of Auckland
Private Bag 92 019
Auckland 1142
Country 17067 0
New Zealand
Phone 17067 0
+64 (9) 630 5160
Fax 17067 0
Email 17067 0
s.poppitt@auckland.ac.nz
Contact person for scientific queries
Name 7995 0
Dr Garth Cooper
Address 7995 0
School of Biological Sciences
University of Auckland
Private Bag 92 019
Auckland 1142
Country 7995 0
New Zealand
Phone 7995 0
+64 (9) 923 7239
Fax 7995 0
Email 7995 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