A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT01028963
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
159 participants
INTERVENTIONAL
2010-01-31
2010-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Placebo capsules once daily
Active control
pioglitazone
pioglitazone 30 mg tablet once daily
Active Study Medication (Group C)
CCX140-B
CCX140-B
CCX140-B capsules once daily (Group C)
Active Study Medication (Group D)
CCX140-B
CCX140-B
CCX140-B capsules once daily (Group D)
Interventions
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Placebo
Placebo capsules once daily
pioglitazone
pioglitazone 30 mg tablet once daily
CCX140-B
CCX140-B capsules once daily (Group C)
CCX140-B
CCX140-B capsules once daily (Group D)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Auchenflower, Queensland, Australia
Kippa-Ring, Queensland, Australia
Beroun, , Czechia
Hlučín, , Czechia
Neratovice, , Czechia
Nový Jičín, , Czechia
Ostrava, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Přelouč, , Czechia
Slaný, , Czechia
Uherský Brod, , Czechia
Uničov, , Czechia
Ústí nad Labem, , Czechia
Basenheim, , Germany
Berlin, , Germany
Cologne, , Germany
Dresden, , Germany
Heidelberg, , Germany
Mannheim, , Germany
Nuremberg, , Germany
Saarlouis, , Germany
Balatonfüred, , Hungary
Budapest, , Hungary
Sátoraljaújhely, , Hungary
Szikszó, , Hungary
Christchurch, , New Zealand
Wellington, , New Zealand
Countries
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Other Identifiers
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CL004_140
Identifier Type: -
Identifier Source: org_study_id
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