Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000739819
Ethics application status
Approved
Date submitted
7/06/2012
Date registered
10/07/2012
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized, double-blind, placebo-controlled, dose-ranging pilot study of the efficacy and safety of GC811007 in subjects with type-2 diabetes mellitus and heart failure
Scientific title
ADDUCE: A randomized, double-blind, placebo-controlled, dose-ranging pilot study of the efficacy and safety of GC811007 in subjects with type-2 diabetes mellitus and heart failure: To assess safety and to determine whether treatment with GC811007 (400 and 1200 mg/day) improves exercise tolerance and indexes of cardiac structure and function
Secondary ID [1] 280001 0
NIL
Universal Trial Number (UTN)
Trial acronym
ADDUCE: Assessment of a Drug for Diabetes and heart failUre using Cardiopulmonary Exercise - (ADDUCE - meaning ‘to cite as an example or proof’)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type-2 diabetes mellitus 285909 0
Diabetes-associated heart failure 285910 0
Condition category
Condition code
Metabolic and Endocrine 286099 286099 0 0
Diabetes
Cardiovascular 286100 286100 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment with GC811007 (two treatment groups 400 and 1200 mg/day), supplied as multiples of 400mg capsules once per day over a six-month period, dose comparison versus placebo.
Intervention code [1] 284325 0
Treatment: Drugs
Comparator / control treatment
Comparison of two different doses of GC811007 compared to placebo (supplied as microcrystalline cellulose in opaque Capsugel gelatin capsules)
Control group
Placebo

Outcomes
Primary outcome [1] 286576 0
The primary efficacy endpoint was the CPET (CardioPulmonary Exercise Testing) assessment of CHANGE IN TIME to reach 70% of peak oxygen consumption (VO2 max) determined by an incremental cycle exercise test, between baseline and Months 4 and 6.
Timepoint [1] 286576 0
Determined by an incremental cycle exercise test, between baseline and Months 4 and 6.
Secondary outcome [1] 296206 0
CHANGE IN VO2 MAX between baseline and Month 4 and Month 6 as measured by CPET
Timepoint [1] 296206 0
Between baseline and Month 4 and Month 6
Secondary outcome [2] 296207 0
Change in left ventricular mass (LVM) and end systolic volume (LVESV) both indexed for BSA at Month 6 as measured by cardiac magnetic resonance imaging (cMRI)
Timepoint [2] 296207 0
At Month 6 as measured by cardiac magnetic resonance imaging (cMRI)
Secondary outcome [3] 296208 0
Measurement of 24 hr urine trace element excretion including urine Cu.
Timepoint [3] 296208 0
Measured at baseline, Month 4 and Month 6
Secondary outcome [4] 296341 0
Change in left ventricular mass (LVM) and end systolic volume (LVESV) at Month 6 as measured by cardiac magnetic resonance imaging (cMRI)
Timepoint [4] 296341 0
At Month 6 as measured by cardiac magnetic resonance imaging (cMRI)

Eligibility
Key inclusion criteria
Men and women > 20 years of age with type-2 diabetes mellitus and heart failure; must complette two CPET tests at baseline
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Healthy patients; subjects younger than 20 years; inability to complete 2 CPET tests at Baseline

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
Parallel
Other design features
Dose comparison
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
93
Accrual to date
Final
Recruitment outside Australia
Country [1] 4161 0
New Zealand
State/province [1] 4161 0

Funding & Sponsors
Funding source category [1] 284761 0
Commercial sector/Industry
Name [1] 284761 0
Protemix Corporation
Country [1] 284761 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Protemix Corporation
Address
Level 28, IAG House
151 Queen Street
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 283651 0
None
Name [1] 283651 0
Address [1] 283651 0
Country [1] 283651 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286808 0
Auckland Health & Disabilities Ethics Committee
Ethics committee address [1] 286808 0
650 Great South Road, Auckland 1051, New Zealand
Ethics committee country [1] 286808 0
New Zealand
Date submitted for ethics approval [1] 286808 0
01/11/2003
Approval date [1] 286808 0
19/02/2004
Ethics approval number [1] 286808 0
AKX/03/12/334

Summary
Brief summary
A pilot study of subjects with type-2 diabetes mellitus and heart failure to determine whether treatment with two different doses of GC811007 improves exercise tolerance and indexes of cardiac structure and function; also to assess safety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33817 0
Address 33817 0
Country 33817 0
Phone 33817 0
Fax 33817 0
Email 33817 0
Contact person for public queries
Name 17064 0
Dr Sally Poppitt
Address 17064 0
School of Biological Sciences
University of Auckland
Private Bag 92 019
Auckalnd 1142
Country 17064 0
New Zealand
Phone 17064 0
+64 (9) 630 5160
Fax 17064 0
Email 17064 0
s.poppitt@auckland.ac.nz
Contact person for scientific queries
Name 7992 0
Dr Garth Cooper
Address 7992 0
School of Biological Sciences
University of Auckland
Private Bag 92 019
Auckalnd 1142
Country 7992 0
New Zealand
Phone 7992 0
+62 (9) 923 7239
Fax 7992 0
Email 7992 0
g.cooper@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.