Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/12/2009
Date assigned
11/02/2010
Last edited
11/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.chemocentryx.com/

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

Publication citations

Additional files

Editorial Notes