A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Type 2 Diabetes Mellitus

Amgen

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: CCX140-B; Drug: Placebo; Drug: pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01028963

CL004_140

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and potential effectiveness of CCX140-B in subjects with Type 2 diabetes mellitus.

Full 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.

Enrollment: 159 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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:

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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159 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Active control

Active Comparator group

Treatment:

Drug: pioglitazone

Active Study Medication (Group C)

Experimental group

Description:

CCX140-B

Treatment:

Drug: CCX140-B

Drug: CCX140-B

Active Study Medication (Group D)

Experimental group

Description:

CCX140-B

Treatment:

Drug: CCX140-B

Drug: CCX140-B