JPRN-jRCT2031210031已完成3 期
Efficacy and safety of once weekly insulin icodec compared to once daily insulin degludec 100 units/mL, both in combination with insulin aspart, in adults with type 1 diabetes.(NN1436-4625) - ONWARDS6
Oyatani Akihito0 个研究点目标入组 80 人开始时间: 2021年4月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Male or female aged >=18 years at the time of signing informed consent.
- •2.Diagnosed with type 1 diabetes mellitus>=1 year prior to the day of screening.
- •3.Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) >= 1 year prior to the day of screening.
- •4.HbA1c <10% at screening visit based on analysis from central laboratory.
排除标准
- •1.Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- •2.Chronic heart failure classified as New York Heart Association (NYHA) Class IV at screening.
- •3.Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
- •4.Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
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