2022-502677-42-00已完成3 期
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.
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 15
- 主要终点
- Change in HbA1c from baseline (week 0) to end of treatment (week 40)
研究概览
简要总结
To confirm superiority of CagriSema (00 mg/00 mg and 00 mg/00 mg) versus placebo on change in HbA1c in participants with T2D in inadequate glycaemic control on diet and exercise
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ 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 ≥ 30 days before screening.
- •HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as determined by central laboratory at screening.
- •BMI ≥ 23 kg/m2 at screening. BMI will be calculated in the 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 < 30 ml/min/1.73 m2 as determined by central laboratory at screening.
- •Treatment with any medication for the indication of diabetes (ever) 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 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.
研究组 & 干预措施
Placebo + Placebo
Placebo
干预措施: Placebo + Placebo (Drug)
cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide
Test
干预措施: cagrilintide semaglutide (Drug)
结局指标
主要结局
Change in HbA1c from baseline (week 0) to end of treatment (week 40)
Change in HbA1c from baseline (week 0) to end of treatment (week 40)
次要结局
- Achievement of HbA1c target values of ≤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)
- Achievement of ≥ 5% weight reduction from baseline (week 0) to end of treatment (week 40)
- Achievement of ≥ 20% 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)
- Relative change in body weight from baseline (week 0) to end of treatment (week 40)
- Achievement of ≥ 10 % weight reduction from baseline (week 0) to end of treatment (week 40)
- Achievement of ≥ 15 % weight reduction from baseline (week 0) to end of treatment (week 40)
- Achievement of HbA1c target values of <7.0% (<53 mmol/mol) at 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, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Very low-density lipoprotein (VLDL) cholesterol, Triglycerides, Free fatty acids, Non-HDL cholesterol from baseline (week 0) to end of treatment (week 40)
- Achievement of T2D remission (HbA1c<6.5% and no antidiabetic medication) at end of study (end of treatment + 12 weeks)
- Ratio to baseline in 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 Vitality score from baseline (week 0) to end of treatment (week 40)
- Change in SF-36v2 score: Physical Component Summary score, Mental 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)
- Change in soluble leptin receptor 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
- 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 + 7 weeks
- 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
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (15)
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