跳至主要内容
临床试验/EUCTR2012-004994-16-BG
EUCTR2012-004994-16-BG进行中(未招募)不适用

Multiple dose trial examining dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes

ovo Nordisk A/S0 个研究点目标入组 603 人开始时间: 2013年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
603

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

  • - Male or female, age = 18 years at the time of signing inform consent
  • - BMI =25 and =40 kg/m^2
  • - Subjects diagnosed with T2D treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening
  • - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive)
  • 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 482
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 121

排除标准

  • - Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants
  • - History of chronic pancreatitis or idiopathic acute pancreatitis
  • - Chronic malabsorption, regardless of aetiology
  • - History of Crohn’s disease, ulcerative colitis, or other inflammatory bowel disease
  • - Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit

研究者

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