A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients With Type 2 Diabetes Mellitus Managed With Oral Hypoglycemic Agent(s)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
研究概览
简要总结
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight/obese men and women with type 2 diabetes mellitus that is managed with oral anti-hyperglycemic agent(s).
- •Body mass index (BMI) 27 to 45 kg/m2, inclusive.
- •Ability to complete a 1 year study
排除标准
- •Pregnancy
- •Use of insulin in any form, exenatide (Byetta) or pramlintide (Symlin) within 3 months prior to screening
- •History of symptomatic heart valve disease
- •Serious or unstable current or past medical conditions
研究组 & 干预措施
Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening
干预措施: Lorcaserin 10 mg twice a day (BID) (Drug)
Lorcaserin 10 mg QD
Lorcaserin 10 mg tablet each morning and placebo tablet each evening
干预措施: Lorcaserin 10 mg once daily (QD) (Drug)
Matching Placebo
Matching placebo tablet each morning and evening
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
时间窗: Baseline and Week 52
The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
次要结局
- Percent Change in Body Weight From Baseline to Week 52(Baseline and Week 52)