EUCTR2019-003589-41-ES进行中（未招募）1 期
A Phase 2, Randomized, Parallel, Open-Label Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 1 Diabetes Mellitus Previously Treated With Multiple Daily Injection Therapy
illy S.A.0 个研究点目标入组 357 人开始时间: 2020年2月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 357
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year.
- •Participants must have been using multiple daily injections without interruption for at least 3 months.
- •Participants must have HbA1c value of =9.5%.
- •Participants must have a body mass index (BMI) of =35 kilograms per meter squared (kg/m²).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 328
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •Participants must not have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening.
- •Participants must not have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
- •Participants must not have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke).
- •Participants must not have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease.
- •Participants must not have estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m².
- •Participants must not have active or untreated cancer.
- •Participants must not be on chronic (>14 days) systemic glucocorticoid therapy.
研究者
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