Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Diet and Exercise
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 93
- 主要终点
- Change in glycated haemoglobin (HbA1c)
研究概览
简要总结
This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.
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
- •Male or female
- •Age 18 years or above at the time of signing the informed consent
- •Diagnosed with type 2 diabetes >=30 days before screening
- •HbA1c 7.0-9.5 percent (53-80 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening
- •Body mass index (BMI) >=23 kilograms per square meter (kg/m^2) 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
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method
- •Renal impairment with estimated Glomerular Filtration Rate less than 30 milliliter per minute per 1.73 square meter (ml/min/1.73 m^2) as determined by central laboratory at screening
- •Treatment with any medication for the indication of diabetes or obesity within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
- •History of use of any injectable therapy for diabetes or obesity. However, short term insulin treatment for a maximum of 14 consecutive 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
研究组 & 干预措施
CagriSema Dose 2
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.
干预措施: Cagrilintide (Drug)
CagriSema Dose 2
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.
干预措施: Semaglutide (Drug)
Placebo Dose 2
Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 2 for 40 weeks.
干预措施: Placebo (Drug)
Cagrisema Dose 1
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks.
干预措施: Cagrilintide (Drug)
Cagrisema Dose 1
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks.
干预措施: Semaglutide (Drug)
Placebo Dose 1
Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 1 for 40 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in glycated haemoglobin (HbA1c)
时间窗: From baseline (week 0) to end of treatment (week 40)
Measured as percentage (%)-points.
次要结局
- Relative change in body weight(From baseline (week 0) to end of treatment (week 40))
- Number of participants who achieve greater than or equal to (>=) 10% body weight reduction(From baseline (week 0) to end of treatment (week 40))
- Number of participants who achieve >=15% body weight reduction(From baseline (week 0) to end of treatment (week 40))
- Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])(At end of treatment (week 40))
- Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol)(At end of treatment (week 40))
- Change in Fasting Plasma Glucose (FPG)(From baseline (week 0) to end of treatment (week 40))
- Number of participants who achieve >=5% body weight reduction(From baseline (week 0) to end of treatment (week 40))
- Change in waist circumference(From baseline (week 0) to end of treatment (week 40))
- Change in systolic blood pressure (SBP)(From baseline (week 0) to end of treatment (week 40))
- Change in diastolic blood pressure (DBP)(From baseline (week 0) to end of treatment (week 40))
- Number of participants who achieve >=20% body weight reduction(From baseline (week 0) to end of treatment (week 40))
- Ratio to baseline in high sensitivity C-reactive protein (hsCRP)(From baseline (week 0) to end of treatment (week 40))
- Ratio to baseline in lipids: Total cholesterol(From baseline (week 0) to end of treatment (week 40))
- Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 40))
- Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 40))
- Ratio to baseline in lipids: Triglycerides(From baseline (week 0) to end of treatment (week 40))
- Ratio to baseline in lipids: Non-HDL cholesterol(From baseline (week 0) to end of treatment (week 40))
- Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication)(At end of study (week 52))
- Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo)(From baseline (week 0) to end of treatment (week 40))
- Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score(From baseline (week 0) to end of treatment (week 40))
- Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to end of treatment (week 40))
- Ratio to baseline in lipids: Free fatty acids(From baseline (week 0) to end of treatment (week 40))
- Change in SF-36v2 score: Physical Component Summary score(From baseline (week 0) to end of treatment (week 40))
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score(From baseline (week 0) to end of treatment (week 40))
- Change in leptin(From baseline (week 0) to end of treatment (week 40))
- Number of Treatment Emergent Adverse Events (TEAEs)(From baseline (week 0) to end of treatment +7 weeks (week 47))
- Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold(From baseline (week 0) to end of treatment + 7 weeks (week 47))
- Change in SF-36v2 score: Mental Component Summary score(From baseline (week 0) to end of treatment (week 40))
- Change in soluble leptin receptor(From baseline (week 0) to end of treatment (week 40))
- Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter(From baseline (week 0) to end of treatment +7 weeks (week 47))