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临床试验/EUCTR2011-004665-32-DE
EUCTR2011-004665-32-DE进行中(未招募)不适用

The effect of insulin degludec in combination with liraglutide and metformin in subjects with type 2 diabetes qualifying for treatment intensification

ovo Nordisk A/S0 个研究点目标入组 320 人开始时间: 2012年6月20日最近更新:
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
320

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

  • - = 18 years of age
  • - Type 2 diabetes
  • - Insulin naïve
  • - Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only BID)
  • - HbA1c (by central laboratory analysis):
  • - 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy
  • - 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID)
  • 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 224
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 96

排除标准

  • - Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks
  • - Calcitonin = 50 pg/mL
  • - Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks
  • - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)

研究者

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