None listed
Conditions
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
Interventions
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 ele
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.
Sponsors
Protemix Corporation Ltd.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
0 to No maximum
Healthy volunteers
Yes
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
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
Outcome results
None listed