NCT04067999已完成不适用
SURE SPAIN: A Multi-centre, Prospective, Non-interventional Study Investigating the Effectiveness of Once-weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes
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
- 230
- 试验地点
- 1
- 主要终点
- Change in Glycated Haemoglobin A1c (HbA1c) (measured in percent)
研究概览
简要总结
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed to them by their doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about their health and diabetes treatment. Participants will complete these during their normally scheduled visits with their doctor.
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
- •Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
- •The decision to initiate treatment with commercially available semaglutide has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study
- •Male or female, age 18 years or older at the time of signing informed consent
- •Diagnosed with type 2 diabetes at least 12 weeks prior to inclusion
- •Available and documented haemoglobin A1c (HbA1c) value equal to or less than 12 weeks prior to initiation of semaglutide treatment
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Treatment with any investigational drug within 90 days prior to enrolment into the study
- •Hypersensitivity to semaglutide or to any of the excipients
研究组 & 干预措施
Semaglutide
Participants will receive semaglutide at the treating physician's discretion as part of the usual clinical practice. The prescription and use of semaglutide is completely independent of this study. Total study duration for the individual patient will be approximately 30 weeks
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change in Glycated Haemoglobin A1c (HbA1c) (measured in percent)
时间窗: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Measured in % points
Change in Glycated Haemoglobin A1c (HbA1c) (measured in mmol/mol)
时间窗: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Measured in mmol/mol
次要结局
- Change in body weight (measured in percent)(Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38))
- HbA1c level at end of study: below 7.0% (53 mmol/mol) (yes/no)(At end of study (week 28 to 38))
- Reduction in HbA1c from baseline to end of study of 1.0% point or more (Y/N)(Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38))
- Patient reported severe or documented hypoglycaemia (yes/no)(Between baseline (week 0) and end of study (week 28-38))
- HbA1c level at end of study: below 7.5% (59 mmol/mol) (yes/no)(At end of study (week 28 to 38))
- HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no)(Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38))
- Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction(Baseline (week 0), end of study (week 28 to 38))
- HbA1c level at end of study: below 8.0% (64 mmol/mol) (yes/no)(At end of study (week 28 to 38))
- Weight reduction of 3.0% or more (yes/no)(Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38))
- Change in score for Short Form (SF)-36 v2: Physical summary component(Baseline (week 0), end of study (week 28 to 38))
- Weight reduction of 5.0% or more (yes/no)(Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38))
- Change in body weight (measured in kg)(Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38))
- Change in waist circumference(Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38))
- Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction )(Baseline (week 0), end of study (week 28 to 38)
- Change in score for SF-36 v2: Mental summary component(Baseline (week 0), end of study (week 28 to 38))
- Patient completed the study under treatment with semaglutide (yes/no)(At end of study (week 28 to 38))
研究者
研究点 (1)
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