Contact information
Type
Scientific
Primary contact
Mr Dan Johnson
ORCID ID
Contact details
850 Maude Avenue
Mountain View
California
94043
United States of America
djohnson@chemocentryx.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01028963
Protocol/serial number
CL004_140
Study information
Scientific title
A randomised, 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
Acronym
Study hypothesis
CCX140-B is safe and well tolerated in subjects with type 2 diabetes mellitus based on subject incidence of adverse events.
Ethics approval
Australia: Bellbery Ethics Committee approved on the 8th December 2009 (ref: C196/09)
Pending as of 21/12/2009:
New Zealand
Czech Republic
Germany
Hungary
Study design
Randomised double-blind placebo- and active-controlled phase II study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 diabetes mellitus
Intervention
1. Placebo capsule, once daily
2. Pioglitazone 30 mg tablet once daily
3. CCX140-B capsule, once daily
Total duration of treatment: 28 days
Total duration of follow-up: 28 days
Intervention type
Drug
Phase
Phase II
Drug names
CCX140-B
Primary outcome measures
Subject incidence of adverse events as measured by subject incidence of adverse events over 28-day dosing period.
Secondary outcome measures
Evaluate the effectiveness of CCX140-B versus placebo as measured by fasting plasma glucose concentration, measured at day 29.
Overall trial start date
01/01/2010
Overall trial end date
30/08/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male, post-menopausal (at least 2 years) or surgically sterile female subjects, aged 18 - 70 years inclusive, with type 2 diabetes mellitus
2. Must have a body mass index greater than or equal to 25 and less than 45 kg/m^2, but if body mass index is greater than or equal to 25 and less than 28 kg/m^2, then waist circumference must be greater then 94 cm for men and greater than 80 cm for women
3. Must be on a stable dose of metformin for at least 8 weeks prior to randomisation
4. Haemoglobin A1c (HbA1c) of 6.5 to 10.0% inclusive and fasting plasma glucose 135 to 270 mg/dL inclusive at screening
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant exclusion criteria
1. Type 1 diabetes mellitus or history of diabetic ketoacidosis
2. Received insulin treatment within 12 weeks of randomisation
3. Received chronic (more than 7 days) systemic glucocorticoid treatment within 12 weeks of randomisation
4. Received sulfonylurea, thiazolidinedione, exenatide, or any other glucose lowering treatment (other than metformin) within 8 weeks of randomisation
5. Symptomatic congestive heart failure requiring prescription medication, clinically evident peripheral oedema, poorly-controlled hypertension (systolic blood pressure greater than 160 or diastolic blood pressure greater than 100), history of unstable angina, myocardial infarction or stroke within 6 months of randomisation, or chronic renal failure
6. History or presence of drug-induced myopathy, drug-induced creatine kinase elevation, or leukopaenia (white blood cell [WBC] count less than 3.5 x 10^9/L)
7. History or presence of any form of cancer within the 5 years prior to randomisation, 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
8. Fasting serum triglyceride greater than 400 mg/dL
Recruitment start date
01/01/2010
Recruitment end date
30/08/2010
Locations
Countries of recruitment
Australia
Trial participating centre
850 Maude Avenue
California
94043
United States of America
Sponsor information
Organisation
ChemoCentryx, Inc. (USA)
Sponsor details
850 Maude Avenue
Mountain View
California
94043
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
ChemoCentryx, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary