Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
This study will evaluate the safety and tolerability of LY3209590 when given by injection under the skin to participants with type 2 diabetes. It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels. Information about any side effects will be documented.
This study will last approximately 17 weeks, not including screening. Screening is required within 4 weeks prior to the start of the study.
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
- 是
入选标准
- •Participants with Type 2 Diabetes Mellitus (T2DM) for at least 1 year
- •Have a glycated hemoglobin (HbA1c) greater than or equal to (≥) 7.0 percent (%) to less than or equal to (≤) 10.5% at screening
- •Have had no episodes of severe hypoglycemia in the past 6 months
- •Are on stable basal insulin (neutral protamine Hagedorn insulin suspension [NPH] insulin, insulin glargine [U100 or U300], or insulin detemir) with or without metformin, dipeptidyl peptidase IV (DPP-IV) inhibitors, sulfonylureas, and sodium-glucose co-transporter 2 (SGLT-2) inhibitors, at a stable dose for at least 3 months before screening
排除标准
- •Have significant lipohypertrophy in the target abdominal injection
- •Have a history of renal impairment
- •Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children)
- •Have proliferative retinopathy or maculopathy and/or severe neuropathy
- •Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening
- •Require daily insulin treatment less than (<) 0.15 unit/kilogram (U/kg) per body weight
- •Are treated with a continuous subcutaneous insulin infusion (CSII) pump
- •Currently receiving degludec insulin therapy, or have been treated with degludec within the past 90 days
研究组 & 干预措施
LY3209590
Escalating doses of LY3209590 administered by subcutaneous (SC) injection
干预措施: LY3209590 (Drug)
Insulin glargine
Insulin glargine administered by SC injection
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through 17 weeks
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Area Under the Drug Plasma Concentration Versus Time Curve from Time Zero to 168 hours (AUC[0-168]) of LY3209590(Week 6)
- Pharmacodynamics (PD): Average Glucose from 7-Point Glucose Profiles(Baseline, Day 4, Day 40, Day 43)