The safety and efficacy of CCX140-B in subjects with type 2 diabetes
| ISRCTN | ISRCTN54010405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54010405 |
| ClinicalTrials.gov number | NCT01028963 |
| Secondary identifying numbers | CL004_140 |
- Submission date
- 15/12/2009
- Registration date
- 11/02/2010
- Last edited
- 20/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Dan Johnson
Scientific
Scientific
850 Maude Avenue
Mountain View
California
94043
United States of America
| djohnson@chemocentryx.com |
Study information
| Study design | Randomised double-blind placebo- and active-controlled phase II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | CCX140-B is safe and well tolerated in subjects with type 2 diabetes mellitus based on subject incidence of adverse events. |
| Ethics approval(s) | Australia: Bellbery Ethics Committee, 08/12/2009, ref: C196/09 Pending as of 21/12/2009: New Zealand Czech Republic Germany Hungary |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | CCX140-B |
| Primary outcome measure | 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 study start date | 01/01/2010 |
| Completion date | 30/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 140 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 30/08/2010 |
Locations
Countries of recruitment
- Australia
- United States of America
Study participating centre
850 Maude Avenue
California
94043
United States of America
94043
United States of America
Sponsor information
ChemoCentryx, Inc. (USA)
Industry
Industry
850 Maude Avenue
Mountain View
California
94043
United States of America
| Website | http://www.chemocentryx.com/ |
|---|---|
"ROR" |
https://ror.org/04gp12571 |
Funders
Funder type
Industry
ChemoCentryx, Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/02/2019 | Yes | No |
Editorial Notes
20/02/2019: Publication reference added.
