Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Chinese Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Hypoglycemia
研究概览
简要总结
The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Chinese participants with type 2 diabetes mellitus who are on a stable dose of basal insulin. Side effects and tolerability will be documented. Blood samples will be taken to assess how the body processes the study drug and the effect of the study drug on blood sugar levels. The study will last up to 18 weeks and may include 18 visits for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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 been diagnosed with Type 2 Diabetes Mellitus (T2DM) and treated with basal insulin and up to one non-insulin anti-hyperglycemic medication.
- •Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
- •Have received a stable daily dose of basal insulin at screening
- •Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening
- •Native Chinese participant who has both parents and all 4 grandparents of Chinese origin.
排除标准
- •Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes
- •Have a history of ketoacidosis or hyperosmolar state/coma episode or severe hypoglycemia or hypoglycemia unawareness in the 6 months prior to screening
- •Are receiving insulin other than once daily basal insulin
- •Have any active infectious or serious disease or major organs insufficiency
- •Women who are pregnant or lactating
研究组 & 干预措施
LY3209590
LY3209590 administered subcutaneously (SC).
干预措施: LY3209590 (Drug)
Insulin glargine
Insulin glargine administered SC.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Incidence and Severity of Hypoglycemia
时间窗: Baseline up to Week 12
Incidence and Severity of Hypoglycemia
Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to Week 12
Number of Participants with One or More AEs and SAEs Considered by the Investigator to be Related to Study Drug Administration
次要结局
- Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose(Baseline through Week 6)
- PD: Change from Baseline in 7-Point Glucose(Baseline through Week 6)