ACTRN12610000400066Active, not recruitingPhase 2
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
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- ChemoCentryx, Inc.
- Enrollment
- 140
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed type 2 diabetes mellitus; must have body mass index greater than or equal to 25 and <45 kg/m2, but if body mass index is greater than or equal to 25 and <28, 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
- •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; cardiac failure or history of cardiac failure (New York Heart Association [NYHA] stages I to IV), clinically evident peripheral edema, poorly controlled hypertension, history of unstable angina, syptomatic coronary artery disease, 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 (white blood cell [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/d
Investigators
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