NCT05716724已完成不适用
A Prospective, Non-interventional Study, Investigating Glycaemic Control and Treatment Patterns Associated With the Use of Once-daily Oral Semaglutide in Type 2 Diabetes Patients Who Intend to Fast During Ramadan in the United Arab Emirates, Saudi Arabia, and Kuwait
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
- 288
- 试验地点
- 20
- 主要终点
- Change in glycated haemoglobin (HbA1c)
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 are using oral semaglutide and planning to fast during Ramadan. Participants will take oral semaglutide as prescribed by the study doctor. The study will last for about 5 months (20 weeks). Participants will be asked to complete a patient diary about how and when they take the oral semaglutide tablets. Participants will complete this diary during the study period as instructed by study 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 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/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
- •Male or female, age above or equal to 18 years at the time of signing informed consent
- •Patients diagnosed with T2D who intend to fast during Ramadan
- •Patient should be on oral semaglutide (at least 4 weeks on maintenance dose) with or without other OADs
- •Available HbA1c value ≤ 30 days prior to the patient enrolment visit (V1) or HbA1c measurement taken in relation with the patient enrolment visit (V1) if in line with local clinical practice
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 patient enrolment visit (V1) and throughout the duration of the study
- •Patients with type-1 diabetes and gestational diabetes
- •Patients who are pregnant or are planning to become pregnant during the conduct of the study
- •Patients who are breastfeeding
- •Patients on Insulin therapy within 2 weeks prior to enrolment
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
研究组 & 干预措施
Participants with T2D
The study is non-interventional as there are no interventions involved and the decision to initiate oral semaglutide treatment is at the discretion of the treating physician and is clearly independent from the decision to include the participant in the study. Participants will be treated with oral semaglutide (at least 4 weeks on maintenance dose) once daily with or without other oral antidiabetics (OADs) as per local label at the discretion of the treating physician.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change in glycated haemoglobin (HbA1c)
时间窗: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
Percentage (%) of HbA1c.
次要结局
- Relative change in body weight(From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan))
- Number of self-reported gastrointestinal (GI) side-effects(From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan))
- Addition of new OAD or increased baseline OAD dose during the study period(At end of follow-up visit (0 to 8 weeks after Ramadan))
- Increase in dose of oral semaglutide(From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan))
- Waiting time of at least 30 min after intake of oral semaglutide and before eating or drinking or taking any other oral medicinal product as per local label and as reported in patient diary(From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan))
- Timing of intake of oral semaglutide as reported in patient diary(From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan))
- Self-reported confirmed hypoglycaemic events(From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan))
- Self-reported hyperglycaemic episodes requiring hospitalisation(From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan))
- Number of participants reporting greater than or equal to (>= 1) severe hypoglycaemic events(From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan))
- Removal of OAD or reduction of baseline OAD dose during the study period(At end of follow-up visit (0 to 8 weeks after Ramadan))
- Decrease in dose of oral semaglutide(From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan))
- Intake of oral semaglutide with up to 120 milliliter (mL) of water as reported in patient diary(From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan))
- Absolute change in body weight(From participant enrolment visit (0 to 8 weeks before Ramadan) to End of follow-up visit (0 to 8 weeks after Ramadan))
研究者
研究点 (20)
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