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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
Gender
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
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] 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
Address [1] 284761 0
Level 28, IAG House
151 Queen Street
Auckland 1010
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
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