A Phase 2 Study to Compare Two Presentations of CagriSema in Participants With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 400
- 试验地点
- 61
- 主要终点
- Change in glycated haemoglobin (HbA1c)
研究概览
简要总结
This study is being done to look at how well a study medicine called CagriSema helps people with diabetes lower their blood sugar. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. The study will last for about 38 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (sex assigned at birth, inclusive of all gender identities).
- •Age 18-64 years (both inclusive) at the time of signing the informed consent.
- •Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 180 days before screening.
- •Glycated haemoglobin (HbA1c) 7.0-10.5 percent (%) (53-91 [millimoles per mole] mmol/mol) (both inclusive) as determined by the central laboratory at screening.
- •Stable daily dose >= 90 days before screening of metformin at effective or maximum tolerated dose as judged by the investigator.
- •Body mass index (BMI) between 25.0 and 39.9 kilograms per square metre (kg/m^2) (both inclusive) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
排除标准
- •Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 millilitre per minute per 1.73 square metre (mL/min/1.73 m^2) as determined by the central laboratory at screening.
- •Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening.
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation.
- •Previous exposure to CagriSema in a clinical study.
研究组 & 干预措施
CagriSema in device 1 + Placebo CagriSema B in device 2
Participants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner.
干预措施: Placebo CagriSema (Drug)
CagriSema in device 1 + Placebo CagriSema B in device 2
Participants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner.
干预措施: CagriSema (Drug)
CagriSema B in device 2 + Placebo CagriSema in device 1
Participants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner.
干预措施: Placebo CagriSema (Drug)
CagriSema B in device 2 + Placebo CagriSema in device 1
Participants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner.
干预措施: CagriSema (Drug)
结局指标
主要结局
Change in glycated haemoglobin (HbA1c)
时间窗: Baseline to week 28
Measured as percentage-points (%-points).
次要结局
- Weekly average cagrilintide (total) and semaglutide concentration (Cavg) based on population pharmacokinetic analyses(From baseline to week 28)
- Change in HbA1c(From baseline to week 28)
- Number of Treatment Emergent Adverse Events (TEAEs)(From baseline to week 35)
- Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per litre [mmol/L]), confirmed by blood glucose (BG) meter, or severe hypoglycaemic episodes (level 3)(From baseline to week 35)