A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-512148 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Treatment Naive And Have Inadequate Glycemic Control on Diet and Exercise

AstraZeneca5 个研究点分布在 3 个国家目标入组 389 人开始时间: 2005年12月最近更新: 2016年11月17日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: AstraZeneca
入组人数: 389
试验地点: 5
主要终点: Mean change from baseline in HbA1c compared to placebo.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 79 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with Type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. HbA1c >= 7% and <=10%.
•Patient either has not been previously treated with antihyperglycemic medication or has been treated for <30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.
•C-peptide > 1.0 ng/ml
•Body Mass Index <= 40 kg/m2
•Serum creatinine < 1.5 mg/dL for men or < 1.4 mg/dL for women.
•No overt proteinuria (microalbumin/creatinine ratio must be <300 mg/g

排除标准

•Unstable renal disease
•Patients with significant liver disease including chronic active hepatitis
•Within the last 6 months has had any of the following cardiovascular event: myocardial infarction, unstable angina, unstable CHF,NYHA Class III or IV CHF, TIA, unstable arrhythmia or cardiac revascularization surgery.
•Subjects with clinically significant anemia