NCT07215312进行中（未招募）2 期
A Phase 2, Randomized, Open-Label, Comparator-Controlled Trial to Evaluate the Efficacy and Safety of LY3938577 in Study Participants, With Type 2 Diabetes Previously Treated With Basal Insulin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 52
- 主要终点
- Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis)
研究概览
简要总结
The purpose of this study is to see how well LY3938577 works and how safe it is compared to degludec in people with type 2 diabetes. Participation in the study will last about 26 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes
- •Are receiving ≥20 units of basal insulin per day and ≤55 units/day and ≤1.5 units/kg/day at screening
- •Have hemoglobin A1c (HbA1c) 7.5% to 10.5% inclusive
- •Have a body mass index (BMI) of 20 or higher and less than 35 kilograms per square meter (kg/m2)
排除标准
- •Have type 1 diabetes
研究组 & 干预措施
Degludec
Active Comparator
Participants will receive degludec SC
干预措施: Degludec (Drug)
LY3938577
Experimental
Participants will receive LY3938577 subcutaneously (SC)
干预措施: LY3938577 (Drug)
结局指标
主要结局
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis)
时间窗: Baseline through Week 20
次要结局
- Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Superiority Analysis)(Baseline through Week 20)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 20)
- Pharmacokinetics (PK): Average Concentration of LY3938577(Baseline through Week 20)
研究者
研究点 (52)
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