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ISRCTN
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ISRCTN54010405
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ClinicalTrials.gov identifier
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NCT01028963
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Public title
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The safety and efficacy of CCX140-B in subjects with type 2 diabetes
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Scientific title
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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
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Acronym
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N/A
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Serial number at source
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CL004_140
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Study hypothesis
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CCX140-B is safe and well tolerated in subjects with type 2 diabetes mellitus based on subject incidence of adverse events.
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Lay summary
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Ethics approval
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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
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Study design
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Randomised double-blind placebo- and active-controlled phase II study
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Type 2 diabetes mellitus
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2010
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Anticipated end date
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30/08/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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140
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Interventions
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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
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Primary outcome measure(s)
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Subject incidence of adverse events as measured by subject incidence of adverse events over 28-day dosing period.
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Secondary outcome measure(s)
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Evaluate the effectiveness of CCX140-B versus placebo as measured by fasting plasma glucose concentration, measured at day 29.
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Sources of funding
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ChemoCentryx, Inc. (USA)
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Trial website
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Publications
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Contact name
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Mr
Dan
Johnson
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Address
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850 Maude Avenue
Mountain View
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City/town
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California
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Zip/Postcode
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94043
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Country
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United States of America
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Email
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djohnson@chemocentryx.com
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Sponsor
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ChemoCentryx, Inc. (USA)
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Address
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850 Maude Avenue
Mountain View
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City/town
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California
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Zip/Postcode
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94043
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Country
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United States of America
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Sponsor website:
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http://www.chemocentryx.com/
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Date applied
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15/12/2009
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Last edited
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11/02/2010
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Date ISRCTN assigned
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11/02/2010
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