2023-509600-15-00已完成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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 49
- 主要终点
- Change in HbA1c from baseline (week 0) to end of treatment (week 60)
研究概览
简要总结
To confirm non-inferiority on change in HbA1c and/or superiority on change in body weight of CagriSema 00 mg/00 mg versus tirzepatide 5 mg in participants with T2D in inadequate glycaemic control on stable dose of metformin, SGLT2i or both
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 mellitus ≥ 180 days before screening.
- •HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
- •BMI ≥ 30 kg/m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening.
- •Stable daily dose(s) ≥ 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 - SGLT2 inhibitor
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 < 30 ml/min/1.73 m2 as determined by central laboratory at screening.
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a eye 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.
- •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.
研究组 & 干预措施
cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide
Test
干预措施: cagrilintide semaglutide (Drug)
Mounjaro 5 mg solution for injection in pre-filled pen, Mounjaro 2.5 mg solution for injection in pre-filled pen
Comparator
干预措施: Mounjaro 2.5 mg solution for injection in pre-filled pen (Drug)
Mounjaro 5 mg solution for injection in pre-filled pen, Mounjaro 2.5 mg solution for injection in pre-filled pen
Comparator
干预措施: Mounjaro 5 mg solution for injection in pre-filled pen (Drug)
结局指标
主要结局
Change in HbA1c from baseline (week 0) to end of treatment (week 60)
Change in HbA1c from baseline (week 0) to end of treatment (week 60)
Relative change in body weight from baseline (week 0) to end of treatment (week 60)
Relative change in body weight from baseline (week 0) to end of treatment (week 60)
次要结局
- Superiority of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in HbA1c from baseline (week 0) to end of treatment (week 60)
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in FPG from baseline (week 0) to end of treatment (week 60)
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of HbA1c target values of ≤6.5% (≤48 mmol/mol) at the end of treatment (week 60)
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of HbA1c target values of <7.0% (<53 mmol/mol) at the end of treatment (week 60)
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of ≥ 10% weight reduction from baseline (week 0) to end of treatment (week 60)
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of ≥ 5% weight reduction from baseline (week 0) to end of treatment (week 60)
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of ≥ 15% weight reduction from baseline (week 0) to end of treatment (week 60)
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of ≥ 20% weight reduction from baseline (week 0) to end of treatment (week 60)
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in systolic blood pressure from baseline (week 0) to end of treatment (week 60)
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 60)
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in waist circumference from baseline (week 0) to end of treatment (week 60)
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Ratio to baseline in lipids from baseline (week 0) to end of treatment (week 60): • Total cholesterol • HDL cholesterol • LDL cholesterol • VLDL cholesterol • Triglycerides • Non-HDL cholesterol
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in SF-36v2 score from baseline (week 0) to end of treatment (week 60): • Physical Component Summary score • Mental Component Summary score • Vitality subscale
- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in IWQOL-Lite-CT from baseline (week 0) to end of treatment (week 60): • Physical Function score • Total score
- Safety and tolerability of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Number of TEAEs from baseline (week 0) to end of treatment (week 60)
- Safety and tolerability of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 mg/dL), confirmed by BG meter) from baseline (week 0) to end of treatment (week 60)
- Safety and tolerability of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: 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 (week 60)
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (49)
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