EUCTR2021-005121-24-HU进行中（未招募）1 期
Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants withoverweight or obesityand type 2 diabetes - REDEFINE 2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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 above or equal to 18 years at the time of signing informed consent
- •- BMI greater than or equal to 27.0 kg/m^2
- •- Diagnosed with type 2 diabetes mellitus for180 days or more before screening
- •- Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic
- •drugs (OAD)s (metformin, a-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter
- •2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single
- •agent or in combination) according to local label
- •- Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing
- •frequency) for at least 90 days before screening
- •- HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening.
- •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 946
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 254
排除标准
- •Diabetes related:
- •- Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
- •- Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2, as measured by the central laboratory at screening
- •- 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
研究者
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