NL-OMON43891已完成3 期
Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes. - onset® 5
ovo Nordisk0 个研究点目标入组 35 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
- 35
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, age * 18 years, at the time of signing informed consent
- •Type 1 diabetes mellitus * 1 year prior to the day of screening
- •Using the same Medtronic pump (Minimed 530G, Paradigm Veo, Paradigm Revel, Paradigm) with CSII(continuous subcutaneous insulin infusion) in a basal-bolus regimen for at least 6 months prior to screening and willing to stay on the same pump throughout the trial
- •HbA1c 7.0-9.0%, as assessed by central laboratory at screening
- •BMI*35.0 kg/m2 at screening
- •Ability and willigness to take at least 3 daily meal-time insulin bolus infusions every day througout the trial.
排除标准
- •Any of the following; myocardial infarction, stroke, hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •History of hospitalisation for ketoacidosis *180 days prior to the day of screening
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
- •Any condition which, in the opinion of the Investigator. might jeopardise a Subject's safety or compliance with the protocol.
研究者
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