jRCT2031210031已完成不适用
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)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Change in HbA1c from baseline
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 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.
结局指标
主要结局
Change in HbA1c from baseline
时间窗: 26 weeks
Comparing the difference in change from baseline in HbA1c between once weekly insulin icodec and once daily insulin degludec both in combination with insulin aspart after 26 weeks of treatment to a non-inferiority limit of 0.3%.
次要结局
未报告次要终点
研究者
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