EUCTR2011-001493-25-BE进行中（未招募）1 期
A trial comparing the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec, both in combination with metformin, in subjects with type 2 diabetes qualifying for treatment intensification - BEGIN™: VICTOZA® ADD-O
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 420
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
- •- The subject must have completed the end of treatment visit of NN1250-3643 with IDeg OD + metformin.
- •- Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •- Participated in NN1250-3643 and treated with IGlar + metformin +/- DPP-IV inhibitor or IDeg + metformin + DPP-IV inhibitor
- •- Previous treatment with glucacon like peptide 1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
- •- Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times the upper limit of normal at end of treatment in NN1250-3643
- •- Impaired renal function defined as serum-creatinine = 125 µmol/L (= 1.4 mg/dL) for males and = 110 µmol/L (= 1.3 mg/dL) for females, at end of treatment in NN1250-3643
研究者
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