Clinical Trials List
Protocol NumberEX9924-4473
Completed
2019-08-01 - 2025-02-28
Phase III
Terminated3
ICD-10E11.9
Type 2 diabetes mellitus without complications
ICD-10E13.9
Other specified diabetes mellitus without complications
ICD-9250.00
Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled
Semaglutide cardiovascular outcomes trial in patients with type 2 diabetes (SOUL)
-
Trial Applicant
NOVO NORDISK PHARMA (TAIWAN) LTD.
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Type 2 diabetes
Objectives
Primary 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 objectives
Key secondary objectives
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
Test Drug
Semaglutide Tablets 3 mg / 7 mg / 14 mg
Active Ingredient
Semaglutide or placebo
Dosage Form
Tablet
Tablet
Tablet
Tablet
Tablet
Dosage
3
7
14
7
14
Endpoints
1. Primary endpoint(s):
Time from randomisation to first occurrence of a major adverse cardiovascular event, a
composite endpoint consisting of: cardiovascular death, non-fatal myocardial infarction or nonfatal stroke
2. Secondary endpoints:
Key confirmatory secondary endpoints
Time from randomisation to first occurrence of:
• A composite chronic kidney disease endpoint consisting of: cardiovascular death,
renal death, onset of persistent ≥ 50% reduction in estimated glomerular filtration rate
(CKD-EPI) compared with baseline, onset of persistent eGFR (CKD-EPI) < 15
mL/min/1.73 m2 or initiation of chronic renal replacement therapy (dialysis or kidney
transplantation)
• Cardiovascular death
• Major adverse limb events, a composite endpoint consisting of: acute limb ischemia
hospitalisation or chronic limb ischemia hospitalisation
Time from randomisation to first occurrence of a major adverse cardiovascular event, a
composite endpoint consisting of: cardiovascular death, non-fatal myocardial infarction or nonfatal stroke
2. Secondary endpoints:
Key confirmatory secondary endpoints
Time from randomisation to first occurrence of:
• A composite chronic kidney disease endpoint consisting of: cardiovascular death,
renal death, onset of persistent ≥ 50% reduction in estimated glomerular filtration rate
(CKD-EPI) compared with baseline, onset of persistent eGFR (CKD-EPI) < 15
mL/min/1.73 m2 or initiation of chronic renal replacement therapy (dialysis or kidney
transplantation)
• Cardiovascular death
• Major adverse limb events, a composite endpoint consisting of: acute limb ischemia
hospitalisation or chronic limb ischemia hospitalisation
Inclution Criteria
All inclusion criteria are based on the patients’ medical records, except for inclusion criterion
for HbA1c (local laboratory or point-of-care device).
• Male or female, age ≥50 years at the time of signing informed consent
• Diagnosed with type 2 diabetes mellitus
• HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive)a
• 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. ≥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. ≥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) < 0.85 at rest
ii. Intermittent claudication with a ≥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 < 60 mL/min/1.73 m2 b
a Latest available and no more than 30 days old local laboratory assessment based on
medical records or point of care measurement.
b Based on medical records using latest available and no more than 6 months old
assessment.
for HbA1c (local laboratory or point-of-care device).
• Male or female, age ≥50 years at the time of signing informed consent
• Diagnosed with type 2 diabetes mellitus
• HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive)a
• 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. ≥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. ≥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) < 0.85 at rest
ii. Intermittent claudication with a ≥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 < 60 mL/min/1.73 m2 b
a Latest available and no more than 30 days old local laboratory assessment based on
medical records or point of care measurement.
b Based on medical records using latest available and no more than 6 months old
assessment.
Exclusion Criteria
• 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
• Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening
• Heart failure presently classified as being in New York Heart Association Class IV
• Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before
screening
pectoris or transient ischaemic attack within the past 60 days prior to the day of
screening
• Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening
• Heart failure presently classified as being in New York Heart Association Class IV
• Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before
screening
The Estimated Number of Participants
-
Taiwan
80 participants
-
Global
9642 participants
