CTRI/2024/10/075299进行中（未招募）3 期
Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. once weekly versus tirzepatide 5 mg s.c. once weekly in participants with type 2 diabetes inadequately controlled on metformin, SGLT2 inhibitor or both
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,428
- 试验地点
- 13
- 主要终点
- 1. Change in HbA1c
研究概览
简要总结
This study aims to compare the effectiveness, safety, and tolerability of CagriSema 1.0 mg/1.0 mg, the lowest maintenance dose under assessment, with tirzepatide at its lowest maintenance dose of 5 mg in participants with type 2 diabetes inadequately controlled on metformin, SGLT2 inhibitor, or both. The study will provide complementary data to the high-dose REIMAGINE 4 NN9388-4894 study and other phase 3a clinical trials for the CagriSema indication of T2D. Two primary efficacy measures, change in HbA1c and relative change in body weight, will be evaluated in line with current clinical care guidelines for T2D, emphasizing the significance of glycemic control and weight management. The study period includes a screening phase of up to 3 weeks, a 60-week intervention period, and a 6-week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male or female.
- •Age 18 years or above at the time of signing the informed consent.
- •Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.
- •Stable daily dose(s) greater than or equal to 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:.
- •SGLT2 inhibitor
- •HbA1c 7.0-10.5percent (53-91 mmol per mol) (both inclusive) as determined by central laboratory at screening.
- •BMI greater than or equal to 30 kg per m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening.
排除标准
- •Participants are excluded from the study if any of the following criteria apply: Diabetes- or weight-related:
- •Renal impairment with estimated Glomerular Filtration Rate < 30 mL/min/1.73 m2 as determined by 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.
- •However, short term insulin treatment for a maximum of 14 consecutive days is 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.
- •Planned initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones or systemic corticosteroids).
- •Previous or planned (during the study period) obesity treatment with surgery or a weight loss device.
- •However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 year before screening, (3) intragastric balloon, if the balloon has been removed > 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening.
- •A self-reported change in body weight > 5% within 90 days before screening irrespective of medical records.
- •General safety:
- •Known or suspected hypersensitivity to investigational medicinal product(s) or related products.
- •Previous randomisation in this study.
- •Previous rescreening in this study.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- •Participation (i.e., signed informed consent) in any other interventional clinical study within 60 days before screening.
- •History of chronic pancreatitis.
- •Acute pancreatitis within 180 days before screening.
- •Planned major change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study, as per investigator discretion.
- •Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- •Myocardial infarction, stroke, transient ischaemic attack or hospitalization for unstable angina pectoris within 180 days before screening.
- •Planned coronary, carotid or peripheral artery revascularisation.
- •Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screening.
- •Use of any medication with unknown or unspecified content within 90 days before screening.
结局指标
主要结局
1. Change in HbA1c
时间窗: 1.From baseline (week 0) to end of treatment (week 60) | 2.From baseline (week 0) to end of treatment(week 60)
2.Relative change in body
时间窗: 1.From baseline (week 0) to end of treatment (week 60) | 2.From baseline (week 0) to end of treatment(week 60)
weight
时间窗: 1.From baseline (week 0) to end of treatment (week 60) | 2.From baseline (week 0) to end of treatment(week 60)
次要结局
- To confirm superiority of CagriSema(1.0 mg per 1.0 mg versus tirzepatide 5 mg)
- To compare the safety and tolerability(of CagriSema 1.0 mg per 1.0 mg versus)
研究者
研究点 (13)
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