A Multicentre, Prospective, Non-Interventional, Single-Arm Study Investigating Glycaemic Control and Patient-Reported Outcomes in Type 2 Diabetes Patients, Uncontrolled on DPP4i Treatment and Who Switch to Oral Semaglutide in a Real-World Setting in Italy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 25
- 主要终点
- Absolute change in glycated haemoglobin (HbA1c) (millimoles per mole [mmol/mol])
研究概览
简要总结
The purpose of the study is to look at the change in blood sugar levels in people with type 2 diabetes who change their treatment from DPP4i to oral semaglutide. Participant will get oral semaglutide as prescribed by the study doctor. The study will last for about 5-6 months. Participants will be asked to complete two questionnaires. One will be about eating behaviour and the other one will be diabetes related. Participant will complete this questionnaire during the normal scheduled visit with study doctor. Participants will be asked questions about their health and diabetes treatment and lab tests as part of their normal doctor's appointment.
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 consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
- •The decision to switch from DPP4i treatment to commercially available oral semaglutide has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the participant in this study
- •Participant with last measurement of HbA1c >= 7.5% at informed consent and treatment initiation visit (V1) or less than or equal to (<=) 90 days before informed consent and treatment initiation visit (V1)
- •Treatment naïve to insulin. An exception is short-term insulin treatment for acute illness for a total of < 14 days
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study
- •Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the informed consent and treatment initiation visit (V1) and throughout the duration of the study
- •Participants with type-1 diabetes
- •Participants who are pregnant or who become pregnant (or who plan to become pregnant) during the study period
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Age < 18 years on the informed consent and treatment initiation visit (V1)
研究组 & 干预措施
Participants with T2D
Participants will be treated with commercially available oral semaglutide according to routine clinical practice at the discretion of the treating physician.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Absolute change in glycated haemoglobin (HbA1c) (millimoles per mole [mmol/mol])
时间窗: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Measured in mmol/mol.
Absolute change in glycated haemoglobin (HbA1c) (percentage [%]-point)
时间窗: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Measured in %-point.
次要结局
- Absolute change in body weight(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))
- HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 3%(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))
- Relative change in body weight(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))
- Absolute change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides)(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))
- Absolute change in waist circumference(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))
- Absolute change in blood pressure (systolic and diastolic)(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))
- Number of participants with HbA1c <6.5%(At end of study (week 40 ± 4 weeks))
- Absolute change in diabetes distress survey (DDS) scores (points)(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))
- Number of participants with HbA1c less than (<) 7%(At end of study (week 40 ± 4 weeks))
- Absolute change in dutch eating behaviour questionnaire (DEBQ) scores (points)(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))
- HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 5%(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))
- Self-reported severe hypoglycaemia during the study period(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))