NCT03987802已完成不适用
An Indian Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance Study of Fiasp® to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 26
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
This study is to investigate the effects of Fiasp®, a mealtime insulin, in patients with diabetes mellitus. The purpose of this study is to collect information about Fiasp®, which is prescribed to the participants by their doctors. Participants will administer Fiasp® as prescribed by their doctors. The study will last for about 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male or female, age equal to or above 18 years at the time of signing the informed consent.
- •Patients diagnosed with diabetes mellitus.
- •Patients scheduled to start treatment with Fiasp® based on the clinical judgement of their treating physician.
排除标准
- •Known or suspected hypersensitivity to study product(s) or related products.
- •Patients on or likely to use insulin pump therapy during the study period
- •Previous participation in this study. Participation is defined as having given signed informed consent.
- •Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation.
- •Participation in any clinical study of an approved or non-approved investigational medicinal product within 1 month before treatment start.
- •Any disorder which in the opinion of the treating physician may jeopardise the patient's safety or compliance with the protocol.
研究组 & 干预措施
Fiasp®
Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.
干预措施: Faster-acting insulin aspart (Drug)
结局指标
主要结局
Adverse Events (AEs)
时间窗: From start of treatment (Week 0) to End of Study Visit (Week 26)
Number of events
次要结局
- Change in HbA1c(From start of treatment (Week 0) to End of Study Visit (Week 26))
- Patient reported Severe or BG confirmed (below 56 mg/dl) hypoglycaemia(From start of treatment (Week 0) to End of Study Visit (Week 26))
- Serious Adverse Drug Reactions (SADRs)(From start of treatment (Week 0) to End of Study Visit (Week 26))
- Patient reported Blood Glucose (BG) confirmed (below 56 mg/dl) hypoglycaemia(From start of treatment (Week 0) to End of Study Visit (Week 26))
- Serious Adverse Events (SAEs)(From start of treatment (Week 0) to End of Study Visit (Week 26))
- Adverse Drug Reactions (ADRs)(From start of treatment (Week 0) to End of Study Visit (Week 26))
- Patient reported severe hypoglycaemia(From start of treatment (Week 0) to End of Study Visit (Week 26))
研究者
研究点 (26)
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