EUCTR2020-004863-14-GR进行中（未招募）1 期
Investigation of the safety and efficacy of semaglutide s.c. in combination with NNC0480-0389 in participants with type 2 diabetes – a dose finding study
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
- 500
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
- •- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.
- •- Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose.
- •- Glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol) (both inclusive)
- •- body mass index (BMI) at least 25 and below 40 kg/m^2
- •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 368
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 127
排除标准
- •- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed.
- •- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- •- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)
研究者
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