NCT04957914已完成1 期
Effects of LY3209590 on Frequency and Severity of Hypoglycaemia Under Conditions of Increased Hypoglycaemic Risk Compared to Insulin Glargine in Participants With Type 2 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
- 54
- 试验地点
- 1
- 主要终点
- Incidence of Documented Hypoglycemia
研究概览
简要总结
The main purpose of this study is to evaluate the effect of study drug known as LY3209590 compared to insulin glargine administered in participants with type 2 diabetes mellitus (T2DM). Side effects and tolerability will be documented. The study will last almost six months and 21 visits for each participant including screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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) for at least 1 year prior to screening
- •Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
- •Be treated for T2DM with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (DPP-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (GLP-1) receptor agonist with or without metformin for at least 3 months prior to screening
排除标准
- •Have an abnormality in the 12-lead ECG
- •Have a supine blood pressure at screening
- •Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5x upper limit of normal (ULN)
- •Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (except T2DM and controlled thyroid disease), haematological, or neurological disorders
- •Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy
- •Have an average weekly alcohol intake
研究组 & 干预措施
Insulin Glargine (Period 1)
Active Comparator
Insulin glargine administered subcutaneously (SC).
干预措施: Insulin Glargine (Drug)
LY3209590 (Period 2)
Experimental
LY3209590 administered SC.
干预措施: LY3209590 (Drug)
结局指标
主要结局
Incidence of Documented Hypoglycemia
时间窗: Baseline through Day 186
Incidence of Documented Hypoglycemia
次要结局
未报告次要终点
研究者
研究点 (1)
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