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

Phase 2

Completed

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

• Registration Number: ACTRN12612000261819
• Lead Sponsor: Protemix Corporation Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 14

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of 4 escalating doses of GC811007 on Urinary Copper excretion over 24 hrs, on Day 1 and Day 7 of each treatment week.[urine copper excretion collected over 24 hrs, on Day 1 and Day 7 of each treatment week.]

Secondary Outcome Measures

Name	Time	Method
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.[Urine metal excretion collected over 24 hrs, on Day 1 and Day 7 of each treatment week.]