NCT00044421已完成3 期
LY333531 Treatment of Peripheral Neuropathy in Patients With Diabetes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 70
- 主要终点
- Reduction in the progression of DPN measured by composite score
研究概览
简要总结
The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have type I or type II Diabetes Mellitus.
- •Have been clinically diagnosed with neuropathy.
- •Have an HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be on insulin therapy.
- •Must be 18 years or older.
- •Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.
排除标准
- •History of significant liver problems.
- •Have poor kidney function.
- •Drink an excess of alcohol or abuse drugs.
- •Have recently participated in or are currently participating in a Medical study in which you receive an experimental drug.
- •Are a woman and are pregnant or breastfeeding, intending to become pregnant within the next 2 years, or are a woman not using an effective method of birth control.
结局指标
主要结局
Reduction in the progression of DPN measured by composite score
次要结局
- Vibration sensation;Electrophysiology of tibial, peroneal and sural nerves;Neurological signs;Neuropathic symptoms;Clinical global impression of change;Health outcome measures
研究者
研究点 (70)
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