Efficacy and Safety of Co-administration of Cagrilintide s.c. 2.4 mg and Semaglutide s.c. 2.4 mg Once Weekly in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 23
- 主要终点
- Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
研究概览
简要总结
This study looks at how well a new medicine called cagrilintide works together with semaglutide on blood sugar levels in people with type 2 diabetes compared to cagrilintide alone or semaglutide alone.
Before a new medicine can be prescribed to people it needs to be tested to see if it is safe and effective.
Participants will either get cagrilintide and semaglutide together or cagrilintide and a dummy medicine or semaglutide and a dummy medicine. Which treatment participants get is decided by chance.
A dummy medicine (placebo) looks like the study medicine but does not contain any active medicine. The dummy medicine is in the study to see if the study medicine works as expected.
Participants will get 2 injections per week on the same day. Participants will take the study medicine with a pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show how.
The study will last for about 39 weeks. Participants will have 12 visits at the clinic and 5 phone calls with the study doctor.
At 6 of the clinic visits participants must not eat and drink for 8 hours before the visit (water is allowed).
Women who can become pregnant cannot take part in this study. Only women that are surgically sterilised or post-menopausal are allowed to participate in this study Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female of non-childbearing potential or male
- •Age above or equal to 18 years at the time of signing informed consent
- •Body mass index (BMI) greater than or equal to 27.0 kg/m^2
- •Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
- •Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening
- •Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at maximum tolerated or effective dose as judged by the investigator: metformin with or without Sodium-glucose co-transporter-2 (SGLT2) inhibitor
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
- •Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 60 ml/min/1.73m^2 by 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
研究组 & 干预措施
Cagrilintide 2.4 mg and semaglutide 2.4 mg
Participants will receive cagrilintide and semaglutide once a week as injections for 32 weeks.
干预措施: Semaglutide 2.4 mg (Drug)
Cagrilintide 2.4 mg and semaglutide 2.4 mg
Participants will receive cagrilintide and semaglutide once a week as injections for 32 weeks.
干预措施: Cagrilintide 2.4 mg (Drug)
Cagrilintide 2.4 mg and placebo (semaglutide)
Participants will receive cagrilintide and placebo (semaglutide) once a week as injections for 32 weeks
干预措施: Cagrilintide 2.4 mg (Drug)
Cagrilintide 2.4 mg and placebo (semaglutide)
Participants will receive cagrilintide and placebo (semaglutide) once a week as injections for 32 weeks
干预措施: Placebo (semaglutide) (Drug)
Semaglutide 2.4 mg and Placebo (cagrilintide)
Participants will receive semaglutide and placebo (cagrilintide) once a week as injections for 32 weeks
干预措施: Semaglutide 2.4 mg (Drug)
Semaglutide 2.4 mg and Placebo (cagrilintide)
Participants will receive semaglutide and placebo (cagrilintide) once a week as injections for 32 weeks
干预措施: Placebo (cagrilintide) (Drug)
结局指标
主要结局
Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
时间窗: Week 0, Week 32
Change in HbA1c from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. The on-treatment without rescue medication period is a subset of the 'on-treatment' observation period and represents the time period where subjects are considered exposed to trial product but have not initiated any rescue medications.
次要结局
- Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)(Week 0, Week 32)
- Percentage Change in Body Weight: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)(Week 0, Week 32)
- Change in Body Weight (Kilogram): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)(Week 0, Week 32)
- Change in Fasting Plasma Glucose (FPG): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)(Week 0, Week 32)
- CGM: Change in Mean Glucose: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)(Week 0, Week 32)
- Percentage of Time Above Range (TAR) Greater Than 10.0 mmol/L (Greater Than 180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)(At week 32)
- Percentage of Time in Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)(At week 32)
- Number of Treatment Emergent Adverse Events (TEAEs)(From baseline (week 0) to week 37)
- Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0mmol/L (54mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)(From baseline (week 0) to week 37)