EUCTR2020-002374-27-IT进行中（未招募）1 期
Efficacy and safety of once weekly insulin icodec compared to once dailyinsulin degludec 100 units/mL, both in combination with insulin aspart, inadults with type 1 diabetes.A 26-week, randomised, multicentre, open-label, active-controlled, parallelgroup, two armed, treat-to-target trial investigating the effect onglycaemic control and safety of treatment with once weekly insulin icodeccompared to once daily insulin degludec, both in combination with insulinaspart in adults with type 1 diabetes, with a 26-week extensioninvestigating long term safety. - ONWARDS 6
OVO NORDISK. S.P.A.0 个研究点目标入组 580 人开始时间: 2021年6月8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
- 580
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
- •- 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 screening.
- •- 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.
- •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 552
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
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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