NCT00246987已完成3 期
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Bristol-Myers Squibb130 个研究点 分布在 3 个国家目标入组 341 人开始时间: 2003年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 341
- 试验地点
- 130
- 主要终点
- Change in HbA1c from baseline to Week 24
研究概览
简要总结
To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise.
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Type 2 diabetes
- •Drug Naive
- •HbA1c >= 7.0% and <= 10.0%
- •Body Mass Index <= 41 kg/m2
- •Serum TG <= 600 mg/dL
排除标准
- •Symptomatic Type 2 diabetes
- •History of bladder cancer
- •History of Myocardial Infarction (MI), coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, Transient Ischemic Attach (TIA), or Cerebrovascular Accident (CVA) within 6 months, congestive heart failure (NYHA Class II and IV), uncontrolled hypertension, history of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
结局指标
主要结局
Change in HbA1c from baseline to Week 24
次要结局
- Changes achieved from baseline in FPG after 24 weeks. Changes achieved from baseline in 3 hour post-prandial AUC for glucose and insulin levels after 24 weeks vs. placebo.
研究者
研究点 (130)
Loading locations...
相似试验
已完成
3 期
A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)Type 2 Diabetes Mellitus, Non Insulin DependentDiabetes Mellitus, Non-Insulin-DependentNCT00701090Merck Sharp & Dohme LLC1,035
已完成
2 期
A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 DiabetesDiabetes Mellitus, Type 2NCT03235050AstraZeneca834
终止
2 期
An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's DiseaseGranulomatous ColitisCrohn's EnteritisGranulomatous EnteritisCrohn's DiseaseNCT03599622Bristol-Myers Squibb239
已完成
3 期
A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)MPS IV ANCT01275066BioMarin Pharmaceutical177
已完成
2 期
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic FunctionCardiac FailureReduced Ventricular Ejection FractionHeart FailureNCT03357731Bristol-Myers Squibb49