NCT06507475已完成不适用
Real World Effectiveness of Oral Semaglutide in Thailand Patients With Type 2 Diabetes: an Observational, Multicentre, Retrospective Cohort Study REAL-world Effectiveness of Oral Semaglutide In a Cohort of Thai patientS With Type 2 Diabetes treatED With Oral Antidiabetic Medications (REALISED) Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Change in Glycated Haemoglobin (HbA1c)
研究概览
简要总结
This study aims to describe the effectiveness of oral semaglutide on glycemic control and body weight control and describe characteristics of type 2 diabetes (T2D) adult patients who are being treated with oral semaglutide in Thailand. Data of eligible patients with T2D will be collected via electronic medical record or paper-format chart review to assess the effectiveness of oral semaglutide. Total study duration for the individual patient will be six months from baseline. The study duration expands within the window period will be 12 months from baseline which will be the optional visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult Thai male or female patients aged greater than or equal to (≥) 18 years.
- •Diagnosed with T2D either through International Classification of Diseases (ICD) code or by physician's description such as documentation in the medical record, and who have not previously been treated with injectable glucose-lowering medication.
- •At least one recent or closest Glycated Haemoglobin (HbA1c) test value available and documented less than or equal to 12 weeks prior to the initiation of oral semaglutide.
- •Had initiated oral semaglutide for diabetes during the target selection period of April 2022 to December
- •All required data for collection should already be accessible prior to the initiation of data collection.
- •Treated with oral semaglutide for at least 6 months without interruption or discontinuation.
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study (if applicable).
- •Participants with any diagnosis of type 1 diabetes (T1D).
- •Medical records documenting prior or ongoing treatment with injectable glucose-lowering treatment.
研究组 & 干预措施
Semaglutide
Participants diagnosed with type 2 diabetes (T2D) who had initiated once-daily oral semaglutide during the target selection period of April 2022 to December 2023 and have not previously been treated with injectable glucose-lowering medication in routine clinical practice.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change in Glycated Haemoglobin (HbA1c)
时间窗: Baseline (week 0), end of study (week 26)
Measured in percentage-point of HbA1c.
次要结局
- Relative Change in Body Weight(At or within 12 months prior to baseline (week 0), end of study (week 26))
- Age of Participants(At baseline (week 0))
- Body Weight(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
- Absolute Change in Body Weight(At or within 12 months prior to baseline (week 0), end of study (week 26))
- Diabetes Related Co-morbidities (modified Charlson Comorbidity Index [mCCI] Category)(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
- Percentage of Participants With Reasons to Initiate Oral Semaglutide Treatment(At baseline (week 0))
- Percentage of Participants Assessed for Age(At baseline (week 0))
- Diabetes Duration of Participants(At baseline (week 0))
- Blood Pressure (systolic/diastolic)(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
- Estimated Glomerular Filtration Rate (eGFR)(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
- Creatinine(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
- Lipid profile: Low-density Lipoprotein Cholesterol (LDL), Non-high-density Lipoprotein Cholesterol (non-HDL), High-density Lipoprotein Cholesterol (HDL), Very Low Density Lipoprotein (VLDL), Total Cholesterol and Triglycerides(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
- Percentage of Participants Achieveing Glycated Haemoglobin (HbA1c) Less Than 7 Percentage (%)(At or within 12 months prior to baseline (week 0), end of study (week 26) and optional visit (week 52-62))
- Number of Participants Assessed for Gender (Male/Female)(At baseline (week 0))
- Percentage of Participants With Smoking History (Never, Previous, Current)(At baseline (week 0))
- Fasting Plasma Glucose(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
- Post Prandial Glucose(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
- Diabetes Medications: Type of Drugs Class(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
- Diabetes Medications: Number(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
- Diabetes Medications: Dosage(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
- Waist Circumference(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
- Body Mass Index(At or within 12 months prior to baseline (week 0) to optional visit (week 52-62))
研究者
研究点 (1)
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