Diabetes Mellitus, Type 2 Chronic kidney disease MedDRA version: 20.0 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10000000486
Conditions
Interventions
Trade Name: Ozempic®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: semaglutide
CAS Number: 910463-68-2
Other descript
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, age 18 years or older at the time of signing informed consent. Japan: 20 years. - Diagnosed with type 2 diabetes mellitus - HbA1c (glycated haemoglobin) equal to or below 10% (equal to or below 86 mmol/mol) - Renal impairment defined either by: a) serum creatinine-based eGFR (estimated glomerular filtration rate) equal to or above 50 and equal to or below 75 mL/min/1.73 m^2 (chronic kidney disease - epidemiology collaboration, CKD-EPI) and UACR (urinary albumin-to-creatinine ratio) above 300 and below 5000 mg/g or b) serum creatinine-based eGFR equal to or above 25 and below 50 mL/min/1.73 m^2 (CKD-EPI) and UACR above 100 and below 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1896 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1264
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that semaglutide delays the progression of renal impairment and lowers the risk of renal and cardiovascular mortality compared to placebo, both added to standard-of-care, in subjects with type 2 diabetes and chronic kidney disease.;Secondary Objective: To compare the effect of treatment with semaglutide versus placebo, both added to standard-of-care in subjects with type 2 diabetes and chronic kidney disease with regards to cardiovascular morbidity, peripheral artery disease, glycaemic control, body weight, blood pressure and safety.;Timepoint(s) of evaluation of this end point: From randomisation (week 0) to end-of-trial (up to 61 months or more);Primary end point(s): Time to first occurrence of a composite endpoint consisting of: Onset of persistent equal to or above 50% reduction in estimated glomerular filtration rate (eGFR) (CKD-EPI) compared with baseline, onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m^2, initiation of chronic renal replacement therapy (dialysis or kidney transplantation), renal death, or cardiovascular death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: For all secondary endpoints: From randomisation (week 0) to end-of-trial (up to 61 months or more) ; Secondary end point(s): 1. Annual rate of change in eGFR (CKD-EPI) (total eGFR slope) 2. Time to first occurrence of a composite cardiovascular MACE endpoint consisting of: - Non-fatal myocardial infarction - Non-fatal stroke - CV death 3. Time to occurrence of all-cause death | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, European Union, France, Greece, Hungary, India, Israel, Japan, Malaysia, Mexico, Netherlands, Russian Federation, Slovakia, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed