NCT02627287已完成1 期
A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Injection success (full dose delivered s.c.) (yes/no)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare Injections with the Medical Device DV3316 Pen-injector versus FlexPen®.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-74 years (both included) at the time of signing informed consent
- •T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) (as diagnosed clinically) at least 12 months prior to screening
- •Daily self-injection(s) with anti-diabetic drug (insulin or Glucagon-Like Peptide-1 (GLP- 1) analogues) in pen-injector or vial/syringe for at least 12 months
- •Caucasians
- •Body Mass Index (BMI) at least 18.5 kg/m^2
排除标准
- •Known or suspected hypersensitivity to test placebo solution incl. m-cresol and phenol or related products (placebo)
- •Female who is pregnant,, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- •Known urticaria factitive or abnormal reactions to mechanical trauma
- •Haemophilia and any diseases affecting blood coagulation
- •Anti-coagulant or inhibitors of platelet aggregation treatment on the day of the visit
- •Intake of any pain-relieving or analgesic drugs on the day of the site visit
- •Skin diseases and infections of the skin in the injection site areas (abdomen and thighs)
- •Lipodystrophia in the injection site areas (abdomen and thighs)
研究组 & 干预措施
DV3316 pen-injector
Experimental
干预措施: DV3316 pen-injector (Device)
DV3316 pen-injector
Experimental
干预措施: placebo (Drug)
FlexPen®
Active Comparator
干预措施: FlexPen® (Device)
FlexPen®
Active Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Injection success (full dose delivered s.c.) (yes/no)
时间窗: By assessment that the dose counter has returned to "0" (EoD confirmation) for the DV3316 pen-injector and for FlexPen® at least 6 seconds after the dose counter has returned to "0"
次要结局
- Subjects' reaction time(Injection completed within 2 minutes after needle insertion)
- Subjects' confidence in injection completion (delivery of correct, full dose)(Injection completed within 2 minutes after needle insertion)
- Subjects evaluation of pen-injector experience(Injections completed within 2 minutes of needle insertion)
- Number of technical complaints(Day 1)
- Number of adverse device effects(Day 1)
- Amount of liquid on the skin (placebo solution or tissue fluid)(Injection completed within 2 minutes after needle insertion)
- Grading of bleeding, redness, bruising and swelling at the site of injection(1 hour after completion of injection)
研究者
研究点 (1)
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