NCT06269120已完成不适用
SEMA-CardioDiab HUNGARY: A Multicentre, Prospective, Non-interventional Study to Evaluate Glycemic Control and Weight Changes in Patients With Type 2 Diabetes Initiating Treatment With Oral Semaglutide by Cardiologists or Diabetologists as Part of Local Clinical Practice in Hungary
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
- 243
- 试验地点
- 19
- 主要终点
- Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5%
研究概览
简要总结
Participant will get oral semaglutde as prescribed by the study doctor. The study will last for about 26 ± 4 weeks (5 to 7 months). Participant will be asked to complete a questionnaire about how they take oral semaglutide tablets during normal scheduled visit with doctor. Participant will also be asked questions about health and their diabetes treatment and lab tests as part of 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 initiate treatment with commercially available oral semaglutide has been made by the patient/LAR and the treating physician based on local label before and independently from the decision to include the patient in this study.
- •Male or female, adults above or equal to 18 years of age at the time of signing informed consent.
- •Diagnosed with type 2 diabetes mellitus.
- •Patient on metformin (Met) with or without modern oral antidiabetic (MOAD, that is Dipeptidyl Peptidase-4 Inhibitor [DPP4i] or/and Sodium-glucose cotransporter-2 Inhibitor [SGLT2i]) with or without insulin therapy.
- •Available HbA1c value > 7.0% within 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice.
排除标准
- •Previous participation in this study (defined as having given informed consent in this study earlier).
- •Treatment with any investigational drug within 30 days prior to enrolment into the study.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Glucagon like peptide -1 receptor agonist (GLP1-RA) treatment within 90 days prior to the Treatment Initiation visit (V1).
- •Patients diagnosed with type 1 diabetes mellitus.
- •Female who is known to be pregnant, undergoing fertility treatment, breastfeeding or intends to become pregnant during the study duration.
研究组 & 干预措施
Patients with type 2 diabetes
Participants with Type 2 Diabetes (T2D) will initiate oral semaglutide at the discretion of the treating physician, based on approved oral semaglutide label in Hungary and independent from the decision to include the patient in the study.
干预措施: Oral Semaglutide (Drug)
结局指标
主要结局
Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5%
时间窗: From Baseline to end of study (week 32)
Participants (yes/no).
次要结局
- Change in HbA1c(From Baseline to end of study (week 32))
- Change in blood pressure (BP) (systolic and diastolic)(From Baseline to end of study (week 32))
- Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG])(From Baseline to end of study (week 32))
- Change in high sensitive C-reactive protein (hsCRP)(From Baseline to end of study (week 32))
- Absolute change in body weight (BW)(From Baseline to end of study (week 32))
- Body weight reduction ≥5%(At end of study (week 32))
- HbA1c reduction ≥1%-point and BW reduction ≥5%(From Baseline to end of study (week 32))
- Change in fasting plasm glucose (FPG)(From Baseline to end of study (week 32))
- Relative change in BW(From Baseline to end of study (week 32))
- HbA1c less than (<) 7.0%(At end of study (week 32))
- HbA1c <6.5%(At end of study (week 32))
- HbA1c reduction ≥1%-point and BW reduction ≥3%(From Baseline to end of study (week 32))
- Change in waist circumference(From Baseline to end of study (week 32))
研究者
研究点 (19)
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