A Multicentre, Single-arm, Retrospective Study Investigating Glycaemic Control in GLP-1 Naive Participants With Type 2 Diabetes Who Initiated Once-weekly Semaglutide (OZEMPIC) in a Real World Setting in North Macedonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Change in glycated haemoglobin (HbA1c)
研究概览
简要总结
The purpose of this study is to investigate glycaemic control and other clinical parameters in glucagon like peptide -1 (GLP-1) naive adult participants with type 2 diabetes (T2D) who initiated once weekly (OW) semaglutide in local clinical practice in North Macedonia. The participants were treated according to current clinical practice, applicable local labels, and standard of care as per physicians' discretion. The total duration of the study is planned to be approximately 30 weeks which is the period from OW semaglutide initiation to end of follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Male or female, age above or equal to 18 years at the time of once weekly (OW) semaglutide initiation.
- •The decision to initiate treatment with commercially available OW semaglutide has been made by the participant and the treating physician before and independently from the decision to include the participant in this study.
- •Adult participants with type 2 diabetes (T2D) initiated with OW semaglutide at least 30 +- 4 weeks prior to data collection.
- •Participants should have baseline glycated haemoglobin (HbA1c) measurement and at least one HbA1c measurement after baseline. For baseline HbA1c measurement, the most recent value less than 12 weeks prior to OW semaglutide initiation will be used.
排除标准
- •Previous participation in this study.
- •Prior use of GLP-1 within last one year.
- •Participants with type-1 diabetes and gestational diabetes.
研究组 & 干预措施
Glucagon like peptide-1 (GLP-1) naive participants with Type 2 Diabetes (T2D)
Glucagon like peptide-1 (GLP-1) naive adult type 2 diabetes (T2D) participants who initiated once weekly (OW) semaglutide were treated according to current clinical practice, applicable local labels, and standard of care as per physicians' discretion.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change in glycated haemoglobin (HbA1c)
时间窗: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Measured as percentage (%) point.
次要结局
- Glycated haemoglobin (HbA1c) less than 7%(At end of follow-up (week 30 +- 4 weeks))
- Change in body weight(From baseline (week 0) to end of follow-up (week 30+- 4 weeks))
- Change in waist circumference(From baseline (week 0) to end of follow-up (week 30+- 4 weeks))
- Change in fasting plasma glucose (FPG)(From baseline (week 0) to end of follow-up (week 30+- 4 weeks))
- Change in Lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides)(From baseline (week 0) to end of follow-up (week 30+- 4 weeks))
- Change in Blood Pressure (systolic and diastolic)(From baseline (week 0) to end of follow-up (week 30+- 4 weeks))
- Reduction in glycated haemoglobin (HbA1c) greater than or equal to (>=) 1%(From baseline (week 0) to end of follow-up (week 30+- 4 weeks))
- Weight loss >= 5%(From baseline (week 0) to end of follow-up (week 30+- 4 weeks))
- HbA1c reduction >= 1% and weight loss of >=3%(From baseline (week 0) to end of follow-up (week 30+- 4 weeks))
- Having at least 1 severe hypoglycaemic episode(At end of follow-up (week 30 +- 4 weeks))
- Weight loss >= 3%(From baseline (week 0) to end of follow-up (week 30+- 4 weeks))