EUCTR2009-011672-29-FI进行中（未招募）不适用
A trial investigating the efficacy and safety of NN1250 compared to insulin detemir in subjects with type 1 diabetes mellitus in a basal/bolus treatment regimen
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 426
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
- •Males or females, age = 18 years (= 20 years for Japan)
- •Type 1 diabetes mellitus (diagnosed clinically) = 12 months
- •Current treatment with any basal/bolus insulin regimen for at least 12 months prior to visit 1
- •HbA1c = 10 % by central laboratory analysis
- •BMI = 35.0 kg/m²
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use within the last 3 months prior to Visit 1 of any other antidiabetic glucose lowering drug than insulin
- •Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors
- •Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during the last 12 months) or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
研究者
相似试验
已完成
3 期
Comparison of NN1250 plus insulin Aspart with insulin Detemir plus insulin Aspart in type 1 diabetes.CTRI/2010/091/000145ovo Nordisk AS60
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