2022-502679-43-00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 as add on to once-daily basal insulin with or without metformin
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 5
- 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 once-daily basal insulin +/- metformin
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 (sex at birth).
- •Age 18 years or above at the time of signing the informed consent.
- •Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- •On stable once-daily dose of basal insulin (minimum of 0.25 IU/kg/day and/or 20 IU/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening.
- •HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
- •BMI ≥ 25 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. For South Africa: please see country-specific requirements in Appendix 13 (Section 10.13).
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an 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.
- •Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke’s questionnaire question
- •Recurrent severe hypoglycaemic episodes within the last year as judged by the Investigator.
研究组 & 干预措施
Placebo + Placebo
Placebo
干预措施: Placebo + Placebo (Drug)
INSULIN GLARGINE , METFORMIN , INSULIN DETEMIR , INSULIN (HUMAN) , INSULIN DEGLUDEC
Auxiliary
干预措施: INSULIN GLARGINE (Drug)
INSULIN GLARGINE , METFORMIN , INSULIN DETEMIR , INSULIN (HUMAN) , INSULIN DEGLUDEC
Auxiliary
干预措施: METFORMIN (Drug)
INSULIN GLARGINE , METFORMIN , INSULIN DETEMIR , INSULIN (HUMAN) , INSULIN DEGLUDEC
Auxiliary
干预措施: INSULIN DETEMIR (Drug)
INSULIN GLARGINE , METFORMIN , INSULIN DETEMIR , INSULIN (HUMAN) , INSULIN DEGLUDEC
Auxiliary
干预措施: INSULIN (HUMAN) (Drug)
INSULIN GLARGINE , METFORMIN , INSULIN DETEMIR , INSULIN (HUMAN) , INSULIN DEGLUDEC
Auxiliary
干预措施: INSULIN DEGLUDEC (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
- 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)
- 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)
- Change in insulin dose from baseline (week 0) to end of treatment (week 40)
- Achievement of insulin dose = 0 U at end of treatment (week 40)
- Ratio to baseline 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
- Change in mean 7-point SMPG profiles from baseline (week 0) to end of treatment (week 40): Mean 7-point profile, Mean postprandial increment (over all meals)
- 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)
- 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 from baseline (week 0) to end of treatment (week 40): Non-HDL cholesterol, Triglycerides, Low-density lipoprotein, Very low-density lipoprotein (VLDL) cholesterol, High-density lipoprotein (HDL) cholesterol, Total cholesterol, Free fatty acids
- 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 from baseline (week 0) to end of treatment (week 40): Physical Component Summary score, Mental Component Summary score
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score from baseline (week 0) to end of treatment (week 40)
- Ratio to baseline in leptin from baseline (week 0) to end of treatment (week 40)
- 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 (5)
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