NCT00231725已完成3 期
Complaints Associated With Use of Pre-Filled Pen B When Used by Patients With Type 2 Diabetes on Twice-Daily Insulin Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 4
- 主要终点
- To collect complaint data on the Pre-filled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months.
研究概览
简要总结
Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home situations. Patients must use insulin lispro injection [rDNA origin] Low Mix twice daily during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes
- •Already on Lilly insulin or beginning insulin therapy
- •25 to 75 years old inclusive
排除标准
- •Currently using, or had used during previous month, oral diabetes medication that is NOT approved for use in combination with insulin in patient's country
- •More than 3 unexplained episodes of severe hypoglycemia within 6 months prior to trial
结局指标
主要结局
To collect complaint data on the Pre-filled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months.
次要结局
- To monitor safety, including all adverse events, hypoglycemia, device-related hypoglycemia, and device-related hyperglycemia
- To assess overall patient perception of the device's performance through a patient questionnaire.
研究者
研究点 (4)
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