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临床试验/2022-502678-18-00
2022-502678-18-00已完成3 期

Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) s.c. in doses 2.4/2.4 mg and 1.0/1.0 mg once weekly versus semaglutide 2.4 mg and 1.0 mg, cagrilintide 2.4 mg and placebo in participants with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor

Novo Nordisk A/S138 个研究点 分布在 5 个国家目标入组 1,223 人开始时间: 2023年11月15日最近更新:
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干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
1,223
试验地点
138
主要终点
Change in HbA1c from baseline (week 0) to end of treatment (week 68)
研究概览入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To confirm superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg on change in HbA1c in participants with T2D in inadequate glycaemic control on stable dose of metformin +/-SGLT2i

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 (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.
  • •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 with or without SGLT2 inhibitors.
  • •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

  • •Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2 as determined by central laboratory at screening.
  • •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 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.

研究组 & 干预措施

cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide

Test

干预措施: cagrilintide semaglutide (Drug)

semaglutide, semaglutide, semaglutide, semaglutide, semaglutide

Comparator

干预措施: semaglutide (Drug)

cagrilintide, cagrilintide, cagrilintide, cagrilintide, cagrilintide

Comparator

干预措施: cagrilintide (Drug)

Placebo + Placebo

Placebo

干预措施: Placebo + Placebo (Drug)

DAPAGLIFLOZIN , METFORMIN

Auxiliary

干预措施: DAPAGLIFLOZIN (Drug)

DAPAGLIFLOZIN , METFORMIN

Auxiliary

干预措施: METFORMIN (Drug)

结局指标

主要结局

Change in HbA1c from baseline (week 0) to end of treatment (week 68)

Change in HbA1c from baseline (week 0) to end of treatment (week 68)

次要结局

  • Superiority of CagriSema 00 mg/00 mg versus cagrilintide 00 mg: Change in HbA1c from baseline (week 0) to end of treatment (week 68)
  • Superiority of CagriSema 00 mg/00 mg versus cagrilintide 00 mg: Relative change in body weight from baseline (week 0) to end of treatment (week 68)
  • Superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg: Change in HbA1c from baseline (week 0) to end of treatment (week 68)
  • Superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg: Relative change in body weight from baseline (week 0) to end of treatment (week 68)
  • Superiority of cagrilintide 00 mg versus placebo: Change in HbA1c from baseline (week 0) to end of treatment (week 68)
  • Superiority of cagrilintide 00 mg versus placebo: Relative change in body weight from baseline (week 0) to end of treatment (week 68)
  • Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg): Achievement of ≥ 10 % weight reduction from baseline (week 0) to end of treatment (week 68)
  • Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg): Achievement of ≥ 15 % weight reduction From baseline (week 0) to end of treatment (week 68)
  • Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg): Achievement of ≥ 20 % weight reduction From baseline (week 0) to end of treatment (week 68)
  • Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): CGM: Change in time in tight target range (TITR) 3.9–7.8 mmol/L (70–140 mg/dL) From baseline (week -3 to end of treatment (week 68)
  • Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in systolic blood pressure (SBP) from baseline (week 0) to end of treatment (week 68)
  • Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Ratio to baseline in triglycerides from baseline (week 0) to end of treatment (week 68)
  • Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Ratio to baseline in non-HDL cholesterols from baseline (week 0) to end of treatment (week 68)
  • Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): CGM: Change in time in range (TIR) 3.9–10.0 mmol/L (70–180 mg/dL) from baseline (week -3) to end of treatment (week 68)
  • Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Ratio to baseline in high sensitivity C-reactive protein (hsCRP) from baseline (week 0) to end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in Fasting Plasma Glucose (FPG) From baseline (week 0) to end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Achievement of HbA1c target values of <7.0% (<53 mmol/mol) at end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Achievement of HbA1c target values of ≤6.5% (≤48 mmol/mol) at end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): CGM: Change in Time above range, >10.0 mmol/L (>180 mg/dL) from baseline (week -3) to end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): CGM: Change in Time above range, >13.9 mmol/L (>250 mg/dL) from baseline (week -3) to end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): CGM: Within-day glycaemic variability (% CV) at end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Achievement of ≥ 5 % weight reduction from baseline (week 0) to end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in waist circumference from baseline (week 0) to end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in diastolic blood pressure (DBP) from baseline (week 0) to end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Ratio to baseline in lipids: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Very low-density lipoprotein (VLDL) cholesterol, Free fatty acids from baseline (week 0) to end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in SF-36v2 score: Physical Component Summary score, Mental Component Summary score from baseline (week 0) to end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score from baseline (week 0) to end of treatment (week 68)
  • Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in Treatment Related Impact Measure for Diabetes (TRIM-D) score from baseline (week 0) to end of treatment (week 68)
  • Safety and tolerability of CagriSema (00 mg/00 mg and 00 mg/00 mg) versus semaglutide (00 mg and 00 mg), placebo and cagrilintide 00 mg: Number of Treatment Emergent Adverse Events (TEAEs) from baseline (week 0) to end of study (week 75)
  • Safety and tolerability of CagriSema (00 mg/00 mg and 00 mg/00 mg) versus semaglutide (00 mg and 00 mg), placebo and cagrilintide 00 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 study (week 75)
  • Safety and tolerability of CagriSema (00 mg/00 mg and 00 mg/00 mg) versus semaglutide (00 mg and 00 mg), placebo and cagrilintide 00 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 study (week 75)
  • Superiority of CagriSema 00 mg/00 mg versus semaglutide 00: Change in HbA1c
  • Superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg: Relative change in body weight
  • Superiority of CagriSema (pooled doses) versus semaglutide (pooled doses): CGM: Change in time in range (TIR) 3.9–10.0 mmol/L (70–180 mg/dL) from baseline (week -3) to end of treatment (week 68)

研究者

申办方类型
Pharmaceutical company
责任方
Principal Investigator
主要研究者

EU Submission Hub

Scientific

Novo Nordisk A/S

研究点 (138)

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