Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000400066
Ethics application status
Approved
Date submitted
20/04/2010
Date registered
18/05/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Type 2 Diabetes Mellitus
Scientific title
A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Type 2 Diabetes Mellitus
Secondary ID [1] 1590 0
NCT01028963, clinicaltrials.gov
Secondary ID [2] 1591 0
ISRCTN54010405, International Standard Randomised Controlled Trial Number Register (ISRCTN)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 257119 0
Condition category
Condition code
Metabolic and Endocrine 257274 257274 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CCX140-B capsules 5 mg once daily for 28 days (Group C); CCX140-B capsules 10 mg once daily for 28 days (Group D)
Intervention code [1] 256281 0
Treatment: Drugs
Comparator / control treatment
Placebo (microcrystalline cellulose) capsules once daily for 28 days (Group A);
Pioglitazone 30mg tablet once daily for 28 days (Group B)
Control group
Active

Outcomes
Primary outcome [1] 258193 0
Subject incidence of adverse events, for example headache or fatigue, as assessed by laboratory tests, physical examinations, and subject-reported adverse events
Timepoint [1] 258193 0
28 days following randomization
Secondary outcome [1] 263836 0
Effect on fasting plasma glucose concentration
Timepoint [1] 263836 0
28 days following randomization

Eligibility
Key inclusion criteria
Diagnosed type 2 diabetes mellitus; must have body mass index greater than or equal to 25 and <45 kg/m2, but if body mass index is greater than or equal to 25 and <28, then waist circumference must be >94 cm for men and >80 cm for women; must be on a stable dose of metformin for at least 8 weeks prior to randomization; Hemoglobin A1c (HbA1c) of 6.5% to 10.0% inclusive and fasting plasma glucose 135 to 270 mg/dL inclusive at Screening
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes mellitus or history of diabetic ketoacidosis; received insulin treatment within 12 weeks of randomization; received chronic (more than 7 days) systemic glucocorticoid treatment within 12 weeks of randomization; received sulfonylurea, thiazolidinedione, exenatide or any other glucose lowering treatment (other than metformin) within 8 weeks of randomization; cardiac failure or history of cardiac failure (New York Heart Association [NYHA] stages I to IV), clinically evident peripheral edema, poorly controlled hypertension, history of unstable angina, syptomatic coronary artery disease, myocardial infarction or stroke within 6 months of randomization, or chronic renal failure; history or presence of drug-induced myopathy, drug-induced creatine kinase elevation, or leukopenia (white blood cell [WBC] count <3.5 x 10(9)/L); history or presence of any form of cancer within the 5 years prior to randomization, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis; fasting serum triglyceride >400 mg/dL

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)
Upon determination of eligibility, randomization, stratification and allocation to treatment are done by a central interactive voice response system (IVRS).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A dynamic randomization method is used. Eligible subjects are stratified based on monocyte chemoattractant protein-1 (MCP-1) polymorphism status and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
29/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2827 0
4021
Recruitment outside Australia
Country [1] 2576 0
New Zealand
State/province [1] 2576 0
Country [2] 2577 0
Czech Republic
State/province [2] 2577 0
Country [3] 2578 0
Germany
State/province [3] 2578 0
Country [4] 2579 0
Hungary
State/province [4] 2579 0

Funding & Sponsors
Funding source category [1] 256816 0
Commercial sector/Industry
Name [1] 256816 0
ChemoCentryx, Inc.
Country [1] 256816 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
ChemoCentryx, Inc.
Address
850 Maude Avenue
Mountain View, CA 94043
USA
Country
United States of America
Secondary sponsor category [1] 256097 0
Commercial sector/Industry
Name [1] 256097 0
Medpace, Inc.
Address [1] 256097 0
4620 Wesley Avenue
Cincinnati, Ohio 45212
USA
Country [1] 256097 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258839 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 258839 0
Ethics committee country [1] 258839 0
Australia
Date submitted for ethics approval [1] 258839 0
Approval date [1] 258839 0
08/12/2009
Ethics approval number [1] 258839 0
Ethics committee name [2] 258859 0
Multi-region Ethics Committee
Ethics committee address [2] 258859 0
Ethics committee country [2] 258859 0
New Zealand
Date submitted for ethics approval [2] 258859 0
Approval date [2] 258859 0
27/01/2010
Ethics approval number [2] 258859 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31032 0
Address 31032 0
Country 31032 0
Phone 31032 0
Fax 31032 0
Email 31032 0
Contact person for public queries
Name 14279 0
Dan Johnson
Address 14279 0
ChemoCentryx, Inc.
850 Maude Avenue
Mountain View, CA 94043
Country 14279 0
United States of America
Phone 14279 0
+1-650-210-2900
Fax 14279 0
Email 14279 0
[email protected]
Contact person for scientific queries
Name 5207 0
Pirow Bekker, MD, PhD
Address 5207 0
ChemoCentryx, Inc.
850 Maude Avenue
Mountain View, CA 94043
Country 5207 0
United States of America
Phone 5207 0
+1-650-210-2900
Fax 5207 0
Email 5207 0
[email protected]

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.