NCT00240253已完成4 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has HbA1c >7.0% and <=10.5%
- •Has a body mass index (BMI) >=25 kg/m2 and <=45 kg/m2
- •Has received insulin glargine for 3 months prior to study start and has been on a stable dose for 1 month prior to study start
- •If taking oral antidiabetic agents, has been on a stable dose for at least 2 months
排除标准
- •Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)
- •Has received any investigational drug within 1 month of screening
研究组 & 干预措施
Pramlintide
Active Comparator
干预措施: pramlintide acetate (Drug)
结局指标
主要结局
To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes.
时间窗: 16 Weeks
次要结局
- To evaluate the effects of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes on markers of cardiovascular risk, fasting serum lipids, fasting plasma glucose, waist circumference, and patient-reported outcomes.(16 Weeks)
研究者
研究点 (1)
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