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

ChemoCentryx, Inc. (USA)0 个研究点目标入组 140 人开始时间: 2010年2月11日最近更新: 2019年3月18日

适应症

试验速览

•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

•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

发起方

ChemoCentryx, Inc. (USA)