Diabetes Mellitus, Type 2 MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, age 50 years or older at the time of signing informed consent 2. Diagnosed with type 2 diabetes mellitus 3. HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive) (Latest available and no more than 30 days old local laboratory assessment based on medical records or point of care measurement). 4. At least one of the below conditions (a-d): a) Coronary heart disease defined as at least one of the following: i. Prior myocardial infarction ii. Prior coronary revascularisation procedure iii. Equal to or above 50% stenosis in coronary artery documented by cardiac catheterisation, computerized tomography coronary angiography iv. Coronary heart disease with ischaemia documented by stress test with any imaging modality b) Cerebrovascular disease defined as at least one of the following: i. Prior stroke ii. Prior carotid artery revascularisation procedure iii. Equal to or above 50% stenosis in carotid artery documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an Ankle-brachial index (ABI) below 0.85 at rest ii. Intermittent claudication with an equal to or above 50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound iii. Prior peripheral artery (excluding carotid) revascularization procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis) d) Chronic kidney disease defined as: i. eGFR below 60 mL/min/1.73 m^2 (Based on medical records using latest available and no more than 6 months old assessment). 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 3857 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5785
Exclusion criteria
Exclusion criteria: 1. Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening 2. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening 3. Heart failure presently classified as being in New York Heart Association Class IV 4. Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that oral semaglutide lowers the risk of major adverse cardiovascular events compared to placebo, both added to standard of care in patients with type 2 diabetes and at high risk of cardiovascular events.;Secondary Objective: To compare the effects of oral semaglutide versus placebo, both added to standard of care in patients with type 2 diabetes and at high risk of cardiovascular events with regards to: - Chronic kidney disease - Cardiovascular events - Peripheral artery disease - Glycaemic control and body weight - Safety;Primary end point(s): Time to first occurrence of a major adverse cardiovascular event (MACE), a composite endpoint consisting of: - CV death - non-fatal myocardial infarction - non-fatal stroke;Timepoint(s) of evaluation of this end point: From randomisation (week 0) to end-of-trial (up to 61 months or more) (trial is event driven) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to first occurrence of a composite endpoint consisting of: - cardiovascular death - renal death - onset of persistent equal to or above 50% reduction in 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) 2. Time to occurrence of cardiovascular death 3. Time to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: - acute limb ischemia hospitalisation - chronic limb ischemia hospitalisation;Timepoint(s) of evaluation of this end point: All secondary endpoints: From randomisation (week 0) to end-of-trial (up to 61 months or more) (trial is event driven) | — |
Countries
Algeria, Argentina, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, European Union, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Thailand, Türkiye, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed