NCT00541567撤回2 期
A Placebo-Controlled, Randomized, Double-Blind, Parallel Arm, Multicenter, Dose-Ranging Phase IIb Trial to Assess Glycemic and Weight Loss Efficacy and Safety of BMS-646256 in Overweight and Obese Patients With Type 2 Diabetes Inadequately Controlled by Diet and Exercise Only or With Metformin or Sulfonylurea Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 600
- 主要终点
- Absolute change from baseline in body weight (kg) and HbA1c (%)
研究概览
简要总结
This is a placebo-controlled, randomized, double-blind, parallel arm, multicenter, dose-ranging phase IIb trial to assess glycemic and weight loss efficacy and safety of BMS-646256 in overweight and obese patients with type 2 diabetes who have been treated with diet and exercise only or with half-maximal or greater metformin (≥1500mg/day) or sulfonylurea monotherapy (stable dose for at least three months), but who remained inadequately controlled (HbA1c >7% and HbA1c<10%).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-70 years and BMI ≥27 with type 2 diabetes who have been treated with diet and exercise only or with half maximal or greater metformin or sulfonylurea monotherapy (stable dose for at least three months), but who remained inadequately controlled (HbA1c >7% and HbA1c<10%).
排除标准
- •Pregnancy
- •Anti-diabetic medications other than baseline metformin or sulfonylurea monotherapy
- •History of myocardial infarction in the prior six months/ History of heart failure defined as New York Heart Association Functional Class I, II, III or IV/ History of symptomatic arrhythmia
- •Active hepatic disease/ Any documented muscle disease
- •History of multiple sclerosis/ Baseline history of tremors, ataxia, anxiety or dizziness
- •Seizures within the last year, stroke, and transient ischemic attack/ Known history of schizophrenia, dementia, or bipolar disorder as defined by DSM IV criteria.
- •Currently depressed subjects or a CES-D score greater or equal to 16 at the screening visit or at baseline (Day 1)/ History of suicide attempt or ideation
- •Previous history of surgical procedures for weight loss (e.g. stomach stapling, bypass)/ Weight loss greater than 5 kg in the prior 3 months
研究组 & 干预措施
1
Placebo Comparator
干预措施: ibipinabant (Drug)
2
Experimental
干预措施: ibipinabant (Drug)
3
Experimental
干预措施: ibipinabant (Drug)
4
Experimental
干预措施: ibipinabant (Drug)
结局指标
主要结局
Absolute change from baseline in body weight (kg) and HbA1c (%)
时间窗: 26 weeks of double-blind therapy
次要结局
- Waist circumference, fasting glucose and insulin, HOMA analysis, blood lipids (triglycerides, total cholesterol, HDL-C, LDL-C, ApoB) and systolic/ diastolic blood pressure(52 weeks treatment followed by 20 weeks off-medication period)
研究者
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