Type 2 Diabetes MellitusPhase 2NCT01028963
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Type 2 Diabetes Mellitus
A Phase 2 study testing pioglitazone and CCX140-B in people with Type 2 Diabetes Mellitus, run by Amgen at 28 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety and potential effectiveness of CCX140-B in subjects with Type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- pioglitazone and CCX140-B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 28 sitesin 5 countries
- Study dates
- Jan 2010to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
Czechia12 sites
Study site
Beroun
Study site
Hlučín
Study site
Neratovice
Study site
Nový Jičín
Study site
Ostrava
Study site
Pardubice
Study site
Prague
Study site
Přelouč
Study site
Slaný
Study site
Uherský Brod
Study site
Uničov
Study site
Ústí nad Labem
Germany8 sites
Study site
Basenheim
Study site
Berlin
Study site
Cologne
Study site
Dresden
Study site
Heidelberg
Study site
Mannheim
Study site
Nuremberg
Study site
Saarlouis
Hungary4 sites
Study site
Balatonfüred
Study site
Budapest
Study site
Sátoraljaújhely
Study site
Szikszó
Australia2 sites
Study site
Auchenflower, Queensland
Study site
Kippa-Ring, Queensland
About this study
Official 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
The purpose of this study is to evaluate the safety and potential effectiveness of CCX140-B in subjects with Type 2 diabetes mellitus.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with Type 2 diabetes mellitus (T2DM) based on subject incidence of adverse events.
The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes medications.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Placebo, pioglitazone, CCX140-B
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo capsules once daily
pioglitazoneDrug
pioglitazone 30 mg tablet once daily
CCX140-BDrug
CCX140-B capsules once daily (Group C)
CCX140-BDrug
CCX140-B capsules once daily (Group D)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Active control | Active comparator | Not described Receives: Drug: pioglitazone |
| Active Study Medication (Group C) | Experimental | CCX140-B Receives: Drug: CCX140-B |
| Active Study Medication (Group D) | Experimental | CCX140-B Receives: Drug: CCX140-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of adverse events
Measured: 28 days
Secondary outcomes (1)
Effect on fasting plasma glucose concentration
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028963
- Sponsor's protocol ID
- CL004_140
- Status last verified
- Mar 2025
- First submitted
- 4 Dec 2009
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01028963
- Acronym / sponsor ID
- CL004_140
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and potential effectiveness of CCX140-B in subjects with Type 2 diabetes mellitus.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with Type 2 diabetes mellitus (T2DM) based on subject incidence of adverse events.
The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes medications.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Active control | Active comparator | Drug: pioglitazone |
| Active Study Medication (Group C) | Experimental | Drug: CCX140-BCCX140-B |
| Active Study Medication (Group D) | Experimental | Drug: CCX140-BCCX140-B |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo capsules once daily | Drug | Placebo |
| pioglitazonepioglitazone 30 mg tablet once daily | Drug | Active control |
| CCX140-BCCX140-B capsules once daily (Group C) | Drug | Active Study Medication (Group C) |
| CCX140-BCCX140-B capsules once daily (Group D) | Drug | Active Study Medication (Group D) |
Primary outcome
Subject incidence of adverse events
Time frame: 28 days
1 secondary outcome
Effect on fasting plasma glucose concentration
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pioglitazone and CCX140-B in people with Type 2 Diabetes Mellitus, run by Amgen at 28 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Czechia, Germany, Hungary, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject incidence of adverse events (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.