NL-OMON52258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.;A 26-week, randomised, multicentre, open-label, active-controlled, parallel group, two armed, treat-to-target trial investigating the effect on glycaemic control and safety of treatment with once weekly insulin icodec compared to once daily insulin degludec, both in combination with insulin aspart in adults with type 1 di - ONWARDS 6
ovo Nordisk0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 18 至 99（—）
入选标准
- •-Male or female aged 18 years or more at the time of signing informed consent.
- •-Diagnosed with type 1 diabetes mellitus at least 1 year prior to the day of
- •-Treated with multiple daily insulin injections (basal and bolus insulin
- •analogue regimes) at least 1 year prior to the day of screening.
- •-HbA1c below 10% at screening visit based on analysis from central laboratory.
排除标准
- •- Myocardial infarction, stroke, hospitalization for unstable angina pectoris
- •or transient ischaemic attack within 180 days prior to the day of screening.
- •-Chronic heart failure classified as New York Heart Association (NYHA) Class IV
- •at screening.
- •-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).
- •-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.
研究者
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