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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12612000293864
• Lead Sponsor: Protemix Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 40

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

Exclusion Criteria

Female Gender, abnormal GTT; abnormal ECG; Abnormal serum iron and ferritin; unable to participate in a 12 day residential study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in urine Cu excretion as measured from:<br>- 24-h urine collections throughout the baseline (diet only, Days 1-6) and treatment periods (GC811007 or placebo, Days 7-12)[Days 1-6 - baseline measurements;<br>Days 7-12 - treatment periods];change in urine Cu excretion as measured from:<br>- 2-h urine collections during the first 10-h of the baseline (Diet only, Day 1) and treatment (GC811007 or placebo, Day 7) periods[Day 1 and Day 7];change in Cu excretion as measured from:<br>24-h fecal collections throughout the baseline (Diet only, Days 2-7) and treatment periods (GC811007 or placebo, Days 8-13)[Baseline at Days 2-7<br>Days 8-13 post-treatment]

Secondary Outcome Measures

Name	Time	Method
Cumulative Cu excretion by both urine and fecal collections.[Daily measurements for 6 days (Diet only, days 1-6 = pretreatment)<br>Days 7-12 Treatment periods (GC811007 or placebo)];Dietary copper intake compared with urine and fecal excretion[Daily measurements for 6 days (Diet only, days 1-6 = pretreatment)<br>Days 7-12 Treatment periods (GC811007 or placebo)];Circulating serum Mg levels[Daily measurements for 6 days (Diet only, days 1-6 = pretreatment)<br>Days 7-12 Treatment periods (GC811007 or placebo)];Trace metal excretion = both urine and fecal excretion<br>Balance = intake compared with urine and fecal excretion[Daily measurements for 6 days (Diet only, days 1-6 = pretreatment)<br>Days 7-12 Treatment periods (GC811007 or placebo)]