Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,533
- 试验地点
- 407
- 主要终点
- Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death
研究概览
简要总结
The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age above or equal to 18 years at the time of signing informed consent. Japan: Male or female, age above or equal to 20 years at the time of signing informed consent
- •Diagnosed with type 2 diabetes mellitus
- •HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol)
- •Renal impairment defined either by:
- •serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or
- •serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g
- •Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening
排除标准
- •Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
- •Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening
- •Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening
- •Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
- •Planned coronary, carotid or peripheral artery revascularisation
- •Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to 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
Semaglutide
Participants are to receive semglutide for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.
干预措施: Semaglutide (Drug)
Placebo
Participants are to receive placebo (semglutide) for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.
干预措施: Placebo (semaglutide) (Drug)
结局指标
主要结局
Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death
时间窗: From Week 0 up to Week 234
Number of participants with first composite renal event i.e., from time of randomization to first occurrence of an onset of persistent greater than or equal to (≥) 50 percent (%) reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease - epidemiology collaboration \[CKD-EPI\]), onset of persistent eGFR (CKD-EPI) \<15 milliliter per minute per 1.73 meter square (mL/min/1.73m\^2), initiation of chronic renal replacement therapy (dialysis or kidney transplantation), renal death, and cardiovascular (CV) death combined data were reported in this outcome measure.
次要结局
- Change From Baseline in Systolic Blood Pressure at Week 104(Baseline (Week 0), Week 104)
- Change From Baseline in Diastolic Blood Pressure at Week 104(Baseline (Week 0), Week 104)
- Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI)(From Week 0 up to Week 234)
- Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)(From Week 0 up to Week 234)
- Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2(From Week 0 up to Week 234)
- Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy(From Week 0 up to Week 234)
- Number of Participants From Time of Randomization to Occurrence of Renal Death(From Week 0 up to Week 234)
- Number of Participants From Time of Randomization to Occurrence of CV Death(From Week 0 up to Week 234)
- Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope)(Week 12, Week 234)
- Change From Baseline in eGFR (CKD-EPI) at Week 12(Baseline (Week 0), Week 12)
- Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104(Baseline (Week 0), Week 104)
- Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to Baseline(Baseline (Week 0), Week 104)
- Number of Participants From Time of Randomization to Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Acute Myocardial Infarction (Non Fatal); Non-fatal Stroke; and CV Death(From Week 0 up to Week 234)
- Number of Participants From Time of Randomization to Time to Occurrence of All-cause Death(From Week 0 up to Week 234)
- Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Myocardial Infarction(From Week 0 up to Week 234)
- Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Stroke(From Week 0 up to Week 234)
- Number of Participants From Time of Randomization to Time to First Occurrence of Major Adverse Limb Events (MALE): Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization(From Week 0 up to Week 234)
- Number of Participants With Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization(From Week 0 up to Week 234)
- Change From Baseline in Body Weight at Week 104(Baeline (Week 0), Week 104)
- Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 104(Baseline (Week 0), Week 104)
- Number of Severe Hypoglycaemic Episodes(From Week 0 up to Week 234)