NCT05887999已完成1 期
A Phase 1, Randomized, Placebo-Controlled, 2-Period, Cross-over, Double- Blind, Single-Dose Study to Evaluate the Effects of LY3532226 on Insulin- Induced Hypoglycemia in Participants With Type 1 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacodynamics (PD): Area under the concentration versus time curve from time 60 to 120 minutes (AUC60-120min) of plasma glucagon during the insulin-induced hypoglycemia
研究概览
简要总结
The main purpose of this study is to evaluate the response of glucagon to insulin-induced low blood sugar after administration of the study drug LY3532226 in participants with type 1 diabetes mellitus (T1DM). The study will also evaluate if LY3532226 helped participants to recover from insulin-induced low blood sugar condition compared to placebo. The study will last approximately 16 weeks excluding screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Participants with type 1 diabetes mellitus (T1DM) for at least 2 years treated with insulin
- •Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
- •Are males or females not of childbearing potential
排除标准
- •Have acute proliferative retinopathy requiring active treatment within 3 months of screening
- •Have been treated with dipeptidyl peptidase-Ni, GLP-1 receptor agonists, GIP agonists, metformin or sodium-glucose cotransporter 2 inhibitors within the previous 3 months
- •Have received systemic or inhaled glucocorticoid therapy
- •Women of childbearing potential
- •Are currently taking part in another clinical study trial involving medical research, or have participated within the last 30 days of screening in a clinical study involving a study intervention
研究组 & 干预措施
LY3532226
Experimental
干预措施: LY3532226 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacodynamics (PD): Area under the concentration versus time curve from time 60 to 120 minutes (AUC60-120min) of plasma glucagon during the insulin-induced hypoglycemia
时间窗: Predose up to 120 mins postdose
PD: AUC60-120min of plasma glucagon during the insulin-induced hypoglycemia
次要结局
- Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT)(Predose up to 120 mins postdose)
- The amount of exogenous glucose infused to maintain a plasma glucose level of >2.5 millimole per liter (mmol/L), after the insulin infusion is terminated.(Predose up to 120 mins postdose)
- Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT(Predose up to 120 mins postdose)
研究者
研究点 (1)
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