Semaglutide in Patients With Type 2 Diabetes: Real-world Analysis in the Canadian LMC Diabetes Registry: The SPARE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,133
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are an injectable, non-insulin therapy for patients with type 2 diabetes (T2D). Semaglutide (Ozempic®) is the newest GLP-1 RA to become available in Canada in 2018, and is administered subcutaneously once-weekly. In clinical trials, semaglutide has been superior to placebo and other antihyperglycemic agents in HbA1c reduction and body weight loss. However, there is little real-world evidence available on the effectiveness of semaglutide in real-world clinical practice.
To better understand the effectiveness of semaglutide on clinical outcomes in a real-world setting, this retrospective cohort study will use the Canadian LMC Diabetes Registry to examine the effects of semaglutide on glycemic control, body weight, and other clinical outcomes in patients with T2D who initiate once-weekly semaglutide as part of usual clinical care in a diabetes specialist practice group in Canada.
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
- •First prescription for semaglutide between Feb 1 2018 and Feb 1 2019
- •Age ≥ 18 years at medication index date
- •Clinical diagnosis of type 2 diabetes for greater than six months
- •≥ one HbA1c measurement at baseline and at follow-up
- •≥ one follow-up visit post index date
- •Informed consent for medical data to be used for research purposes
排除标准
- •Clinical diagnosis of type 1 diabetes
- •Recent eGFR <40 ml/min/1.73m2
- •Documented history of bariatric surgery
结局指标
主要结局
Change in HbA1c
时间窗: 3 to 6 months
Change in HbA1c (%) between baseline and last measured value at 3 to 6 months follow-up
次要结局
- Proportion of patients who achieve HbA1c ≤8.0%(3 to 6 months)
- Proportion of patients who achieve HbA1c reduction ≥0.5%(3 to 6 months)
- Proportion of patients who achieve HbA1c reduction ≥1.0%(3 to 6 months)
- Proportion of patients who achieve weight loss ≥10%(3 to 6 months)
- Change in body weight(3 to 6 months)
- Change in diastolic blood pressure (DBP)(3 to 6 months)
- Change in non-HDL cholesterol(3 to 6 months)
- Change in estimated glomerular filtration rate (eGFR)(3 to 6 months)
- Change in LDL cholesterol(3 to 6 months)
- Change in body mass index (BMI)(3 to 6 months)
- Proportion of patients who report ≥ 1 yearly incidence of severe hypoglycemia(3 to 6 months)
- Proportion of patients who achieve weight loss ≥5%(3 to 6 months)
- Change in alanine amino transaminase (ALT)(3 to 6 months)
- Proportion of patients who report ≥ 1 weekly incidence of any hypoglycemia(3 to 6 months)
- Change in systolic blood pressure (SBP)(3 to 6 months)
- Proportion of patients who achieve HbA1c ≤7.0%(3 to 6 months)
- Change in triglycerides(3 to 6 months)