NCT00094146已完成2 期
Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate Obesity
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- The percent change at baseline compared to 6 months in body weight
研究概览
简要总结
This study is in patients with at least moderate obesity (Body Mass Index [BMI] > 30 kg/m2 or approximately 30 or more pounds overweight) and who also produce too much insulin (insulin stores sugar as fat). Sandostatin LAR® Depot suppresses insulin, and is being developed to help with weight loss in people who find it hard to lose weight on their own because they produce too much insulin.
The main purpose of the study is to find the lowest dose of Sandostatin LAR® Depot that safely helps overweight people lose weight. The study will also compare weight loss in obese patients who receive one of three different dosages of Sandostatin LAR Depot or placebo.
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
- •You may qualify for this study if you:
- •are between the ages of 18-70 (male or female)
- •are at least moderately obese (BMI > 30 kg/m2 or approximately 30 or more pounds overweight)
- •and pass an oral glucose tolerance test (a 3 hour test to determine if your body produces too much insulin)
排除标准
- •You are not qualified for this study if you:
- •have diabetes
- •have been able to lose weight with diet and exercise alone
- •have previously received Sandostatin LAR® Depot
结局指标
主要结局
The percent change at baseline compared to 6 months in body weight
次要结局
- Compare changes from baseline and at 6 months in body mass index (BMI), percentage of total body fat percentage of abdominal fat, leptin, and waist-to-hip ratio
研究者
研究点 (5)
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