NCT05706506已完成4 期
An Open-Label, Single-Arm, Phase 4 Study to Assess Glycemic Control When Adults With Type 2 Diabetes Switch From a GLP-1 RA to Tirzepatide (SURPASS-SWITCH-2)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 31
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The main purpose of this study is to investigate the effects of switching from glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy to tirzepatide glucose-dependent insulinotropic polypeptide (GIP) GLP-1 RA agonist in participants with type 2 diabetes (T2D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Have Type 2 diabetes (T2D)
- •Have an HbA1c c ≥6.5% (≥48 mmol/mol) to ≤9.0% (≤75 mmol/mol)
- •Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m²) at screening
- •Have been on a stable treatment dose of 1 of the listed GLP-1 RAs for ≥3 months
- •No treatment with oral antidiabetic medicine (OAM) or on stable doses (for at least 3 months before screening) of up to 3 OAM. The OAM may include metformin, sodium-glucose linked transporter-2 inhibitor (SGLT-2i), thiazolidinediones, or α-glucosidase inhibitors.
排除标准
- •Have Type 1 Diabetes (T1D)
- •Have a clinical history of
- •proliferative diabetic retinopathy
- •diabetic maculopathy, or
- •non-proliferative diabetic retinopathy that requires acute treatment
- •Are at high risk for cardiovascular disease or have a history of
- •myocardial infarction
- •percutaneous coronary revascularization procedure
- •carotid stenting or surgical revascularization
- •nontraumatic amputation
- •peripheral vascular procedure
- •cerebrovascular accident
- •or hospitalization for congestive heart failure
- •Have New York Heart Association (NYHA) Functional Classification Class IV congestive heart failure
- •Have a history of ketoacidosis or hyperosmolar state or coma
- •Have a history of severe hypoglycemia or hypoglycemia unawareness within the 6 months.
研究组 & 干预措施
5 milligrams (mg) Tirzepatide
Experimental
Participants received 5 mg tirzepatide subcutaneously administered once weekly for 12 weeks.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline, Week 12
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
次要结局
- Change From Baseline in Percentage of Time Per Day That Continuous Glucose Monitoring (CGM)-Derived Values Were >180 Milligram/Deciliter (mg/dl) (10 Millimole/Liter (mmol/L))(Baseline, Week 4)
- Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L)(Baseline, Week 12)
- Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)(Baseline, Week 12)
- Change From Baseline in Fasting Serum Glucose (FSG)(Baseline, Week 12)
- Change From Baseline in Weight(Baseline, Week 12)
研究者
研究点 (31)
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