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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01028963




Trial ID
NCT01028963
Ethics application status
Date submitted
4/12/2009
Date registered
8/12/2009
Date last updated
8/02/2012

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] 0 0
CL004_140
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - pioglitazone
Treatment: Drugs - CCX140-B
Treatment: Drugs - CCX140-B

Placebo Comparator: Placebo -

Active Comparator: Active control -

Experimental: Active Study Medication (Group C) - CCX140-B

Experimental: Active Study Medication (Group D) - CCX140-B


Treatment: Drugs: Placebo
Placebo capsules once daily

Treatment: Drugs: pioglitazone
pioglitazone 30 mg tablet once daily

Treatment: Drugs: CCX140-B
CCX140-B capsules once daily (Group C)

Treatment: Drugs: CCX140-B
CCX140-B capsules once daily (Group D)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subject incidence of adverse events
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Effect on fasting plasma glucose concentration
Timepoint [1] 0 0
28 days

Eligibility
Key inclusion criteria
Key

- Diagnosed type 2 diabetes mellitus

- Must have a body mass index =25 and <45 kg/m2, but if body mass index is =25 and <28
kg/m2, 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

Key
Minimum age
18 Years
Maximum age
70 Years
Gender
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

- Symptomatic congestive heart failure requiring prescription medication, clinically
evident peripheral edema, poorly-controlled hypertension (systolic blood pressure >160
or diastolic blood pressure >100), history of unstable angina, 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 (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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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 in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Auchenflower
Recruitment hospital [2] 0 0
- Kippa-Ring
Recruitment postcode(s) [1] 0 0
- Auchenflower
Recruitment postcode(s) [2] 0 0
- Kippa-Ring
Recruitment outside Australia
Country [1] 0 0
Czech Republic
State/province [1] 0 0
Beroun
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Hlucin
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Neratovice
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Novy Jicin
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Ostrava
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Pardubice
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Prague
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Prelouc
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Slany
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Uhersky Brod
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Unicov
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Usti nad Labem
Country [13] 0 0
Germany
State/province [13] 0 0
Basenheim
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Cologne
Country [16] 0 0
Germany
State/province [16] 0 0
Dresden
Country [17] 0 0
Germany
State/province [17] 0 0
Heidelberg
Country [18] 0 0
Germany
State/province [18] 0 0
Mannheim
Country [19] 0 0
Germany
State/province [19] 0 0
Nuremberg
Country [20] 0 0
Germany
State/province [20] 0 0
Saarlouis
Country [21] 0 0
Hungary
State/province [21] 0 0
Balatonfuered
Country [22] 0 0
Hungary
State/province [22] 0 0
Budapest
Country [23] 0 0
Hungary
State/province [23] 0 0
Satoraljaujhely
Country [24] 0 0
Hungary
State/province [24] 0 0
Szikszo
Country [25] 0 0
New Zealand
State/province [25] 0 0
Christchurch
Country [26] 0 0
New Zealand
State/province [26] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ChemoCentryx
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and potential effectiveness of CCX140-B
in subjects with Type 2 diabetes mellitus.
Trial website
https://clinicaltrials.gov/show/NCT01028963
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pirow Bekker, MD, PhD
Address 0 0
ChemoCentryx, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries