CTRI/2023/04/051486进行中（未招募）3 期
Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutides.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight orobesity and type 2 diabetes
ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female
- •2.Age above or equal to 18 years at the time of signing informed consent
- •3. BMI greather than or equal to 27.0 kg per m2
- •4. Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
- •5.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
- •6. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
- •7. HbA1c below or equal to 10% (86 mmol/mol) as measured by the central laboratory at screening
排除标准
- •1.Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness.
- •2.Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL per min per 1.73 m2 (below 45 mL per min per 1.73 m2 in participants treated with SGLT2i), as measured by the central laboratory at screening.
- •3.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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