EUCTR2009-010662-28-IE进行中（未招募）不适用
A trial comparing efficacy and safety of NN1250 and insulin glargine in subjects with type 2 diabetes
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
- 450
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
- •Insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days).
- •Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, a-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated:
- •- Metformin: alone or in combination (including fixed combination) 1500 mg daily, or
- •maximum tolerated dose (at least 1000 mg daily)
- •- Insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling
- •- DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling
- •- a-glucosidase-inhibitors (Acarbose): minimum half of the daily maximal dose or maximum tolerated dose
- •HbA_1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- •BMI = 45.0 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: thiazoledinediones (TZDs), exenatide or liraglutide
- •Anticipated change in concomitant medication known to interfere significantly with glucose
- •metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors
- •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
- •Known or suspected allergy to any of the trial products or related products
- •Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the Investigator’s opinion could interfere with the results of the trial
研究者
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