Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 14
- 主要终点
- Participant Preference Between 2 Injection Devices Based on Global Preference Item
研究概览
简要总结
In this study participants will try out two different types of drug injection pens (dulaglutide and semaglutide) on a practice pad and decide which device they prefer. No study drug will be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •Diagnosed with type 2 diabetes
- •Self-injection naïve to all injectable treatment (for example, diabetes therapies and other medical conditions)
- •Injection naïve to performing all injectable treatment (for example, diabetes therapies and other medical conditions) to others
排除标准
- •Currently diagnosed with gestational diabetes and/or type 1 diabetes
- •Cognitive or physical difficulties that could interfere with ability to understand the training, perform the injection tasks, or complete the study questionnaires as judged by the investigator
- •Is a health care practitioner who is trained in giving injections
研究组 & 干预措施
Dulaglutide Pen
Injection of commercial dulaglutide pen on a practice pad.
干预措施: Dulaglutide Pen (Drug)
Semaglutide Pen
Injection of commercial semaglutide pen on a practice pad.
干预措施: Semaglutide Pen (Drug)
结局指标
主要结局
Participant Preference Between 2 Injection Devices Based on Global Preference Item
时间窗: Day 1
Preference of injection device was assessed by questionnaire which asks, "Overall, which device do you prefer?" The Prescott test will be run to examine if a statistically significant difference in preference between the devices exits, while controlling for order effects and taking into account the neutral responses.
次要结局
- Participant Preference Between 2 Injection Devices Based on Ease of Use(Day 1)