CTRI/2024/03/064047进行中（未招募）3 期
Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. once weekly versus tirzepatide 15 mg s.c. once weekly in participants with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Novo Nordisk
- 入组人数
- 1,000
- 试验地点
- 17
- 主要终点
- 1) Change in HbA1c
研究概览
简要总结
This is an interventional, multi-national, multi-centre, randomised, parallel-group, open-label study
comparing CagriSema versus tirzepatide.
Rationale:
The purpose of the present study is to compare the effect of CagriSema 2.4 mg/2.4 mg versus
tirzepatide 15 mg on glycaemic control and weight loss as well as safety and tolerability in people
with type 2 diabetes treated with metformin with or without a sodium glucose transporter type 2
inhibitor (SGLT2i).
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 99.00 Year(s)（—）
- 性别
- All
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 more than or equal to 180 days before screening.
- •Stable daily dose(s) more 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: metformin with or without an SGLT2 inhibitor.
- •HbA1c 7.0-10.5 percent (53-91 mmol per mol) (both inclusive) as determined by central laboratory at screening.
- •BMI more 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
- •1.Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- •2.Renal impairment with estimated Glomerular Filtration Rate more than 30 ml per min per 1.73 m2 as determined by central laboratory at screening.
- •3.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 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.
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 | 68) | 2) From baseline | (week 0) to end of | treatment (week | 68)
2) Relative change in body
时间窗: 1) From baseline | (week 0) to end of | treatment (week | 68) | 2) From baseline | (week 0) to end of | treatment (week | 68)
weight
时间窗: 1) From baseline | (week 0) to end of | treatment (week | 68) | 2) From baseline | (week 0) to end of | treatment (week | 68)
次要结局
- To confirm superiority of CagriSema 2.4 mg per 2.4 mg versus tirzepatide 15 mg on(change in HbA1c)
- To compare the effect of CagriSema 2.4 mg per 2.4 mg versus tirzepatide 15 mg on Change in FPG(From baseline)
- To compare the effect of CagriSema 2.4 mg per 2.4 mg versus tirzepatide 15 mg on Achievement of more than or equal to 5 percent weight(reduction)
- Achievement of HbA1c target(values of less than 7.0 percent(less than 53 mmol per mol))
- Achievement of HbA1c target(values of less than 6.5 percent (less than 48 mmol per mol))
- Achievement of more than 10 percent weight reduction(From baseline)
- Achievement of more than 15 percent weight reduction(From baseline)
- Achievement of more than 20 percent weight reduction(From baseline (week 0) to end of treatment (week 68))
- Change in systolic blood(pressure)
- Change in diastolic blood(pressure)
- Change in waist(circumference)
- Ratio to baseline in lipids(Total cholesterol)
- Change in SF-36v2 score(Physical Component)
- Change in IWQOL-Lite-CT:(Physical Function score)
- To compare the safety and tolerability of(CagriSema 2.4 mg per 2.4 mg versus tirzepatide)
- Score points(To compare the safety and tolerability of)
研究者
研究点 (17)
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