Clinical Trials List
Protocol NumberNN9924-4221
NCT Number(ClinicalTrials.gov Identfier)NCT02692716
2016-07-19 - 2018-06-25
Phase III
Terminated4
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
PIONEER 6 – Cardiovascular outcomes. A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes
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Trial Applicant
NOVO NORDISK PHARMA (TAIWAN) LTD.
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Sponsor
Novo Nordisk A/S
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
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
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Condition/Disease
Type 2 Diabetes Mellitus
Objectives
The primary objective is to confirm that treatment with oral semaglutide does not result in an
unacceptable increase in cardiovascular risk compared to placebo (rule out 80% excess risk) in
subjects with type 2 diabetes at high risk of cardiovascular events.
The secondary objectives are to compare the efficacy and safety of oral semaglutide versus placebo
in subjects with type 2 diabetes at high risk of cardiovascular events.
Test Drug
Oral Semaglutide
Active Ingredient
Semaglutide、SNAC
Dosage Form
Tablet
Dosage
3/7/14 mg per tablet
Endpoints
1. Primary endpoint(s):
The primary endpoint is time from randomisation to first occurrence of a major adverse
cardiovascular event (MACE) composite endpoint consisting of: cardiovascular death, non-fatal
myocardial infarction or non-fatal stroke.
2. Secondary endpoints:
Time from randomisation to first occurrence of an expanded composite cardiovascular
endpoint consisting of: cardiovascular death, non-fatal myocardial infarction, non-fatal
stroke, unstable angina requiring hospitalisation or hospitalisation for heart failure
Time from randomisation to first occurrence of each of the individual components in the
expanded composite cardiovascular endpoint
Time from randomisation to first occurrence of a composite endpoint consisting of:
all-cause death, non-fatal myocardial infarction or non-fatal stroke
For the primary and the key secondary endpoints, maximum treatment duration is dependent on
event rates and is estimated to be no longer than 19 months.
The primary endpoint is time from randomisation to first occurrence of a major adverse
cardiovascular event (MACE) composite endpoint consisting of: cardiovascular death, non-fatal
myocardial infarction or non-fatal stroke.
2. Secondary endpoints:
Time from randomisation to first occurrence of an expanded composite cardiovascular
endpoint consisting of: cardiovascular death, non-fatal myocardial infarction, non-fatal
stroke, unstable angina requiring hospitalisation or hospitalisation for heart failure
Time from randomisation to first occurrence of each of the individual components in the
expanded composite cardiovascular endpoint
Time from randomisation to first occurrence of a composite endpoint consisting of:
all-cause death, non-fatal myocardial infarction or non-fatal stroke
For the primary and the key secondary endpoints, maximum treatment duration is dependent on
event rates and is estimated to be no longer than 19 months.
Inclution Criteria
Inclusion criteria
For an eligible subject, all inclusion criteria must be answered “yes”.
1. Informed consent obtained before any trial-related activities. Trial-related activities are any
procedures that are carried out as part of the trial, including activities to determine suitability for
the trial.
2. Male or female diagnosed with type 2 diabetes.
3. Age ≥ 50 years at screening and at least one of the below conditions:
a. prior myocardial infarction
b. prior stroke or transient ischaemic attack (TIA)
c. prior coronary, carotid or peripheral arterial revascularisation
d. > 50% stenosis on angiography or imaging of coronary, carotid or lower extremity
arteries
e. history of symptomatic coronary heart disease documented by e.g. positive
exercise stress test or any cardiac imaging or unstable angina pectoris with ECG
changes
f. asymptomatic cardiac ischaemia documented by positive nuclear imaging test or
exercise test or stress echo or any cardiac imaging
g. chronic heart failure New York Heart Association (NYHA) class II-III
h. moderate renal impairment (corresponding to an estimated glomerular filtration
rate (eGFR) between 30-59 mL/min/1.73 m2
)
or
Age ≥ 60 years at screening and at least one of the below risk factors:
i. microalbuminuria or proteinuria
j. hypertension and left ventricular hypertrophy by ECG or imaging
k. left ventricular systolic or diastolic dysfunction by imaging
l. ankle/brachial index < 0.9
For an eligible subject, all inclusion criteria must be answered “yes”.
1. Informed consent obtained before any trial-related activities. Trial-related activities are any
procedures that are carried out as part of the trial, including activities to determine suitability for
the trial.
2. Male or female diagnosed with type 2 diabetes.
3. Age ≥ 50 years at screening and at least one of the below conditions:
a. prior myocardial infarction
b. prior stroke or transient ischaemic attack (TIA)
c. prior coronary, carotid or peripheral arterial revascularisation
d. > 50% stenosis on angiography or imaging of coronary, carotid or lower extremity
arteries
e. history of symptomatic coronary heart disease documented by e.g. positive
exercise stress test or any cardiac imaging or unstable angina pectoris with ECG
changes
f. asymptomatic cardiac ischaemia documented by positive nuclear imaging test or
exercise test or stress echo or any cardiac imaging
g. chronic heart failure New York Heart Association (NYHA) class II-III
h. moderate renal impairment (corresponding to an estimated glomerular filtration
rate (eGFR) between 30-59 mL/min/1.73 m2
)
or
Age ≥ 60 years at screening and at least one of the below risk factors:
i. microalbuminuria or proteinuria
j. hypertension and left ventricular hypertrophy by ECG or imaging
k. left ventricular systolic or diastolic dysfunction by imaging
l. ankle/brachial index < 0.9
Exclusion Criteria
Exclusion criteria
For an eligible subject, all exclusion criteria must be answered "no".
1. Known or suspected hypersensitivity to the trial product or related products.
2. Previous participation in this trial. Participation is defined as signed informed consent.
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
potential and not using adequate contraceptive methods (adequate contraceptive measures as
required by local regulation or practice. Local country regulations or practices are specified in
section 8 of the protocol).
4. Receipt of any investigational medicinal product within 90 days before screening.
For Brazil only: Participation in other clinical trials within one year prior to screening unless there
is a direct benefit to the research subject at the investigator´s discretion.
5. Participation in another clinical trial of an investigational medicinal product. Participation in a
clinical trial which evaluate stent(s) is allowed.
6. Current or previous (within 90 days prior to screening) treatment with any GLP-1 receptor
agonist, DPP-4 inhibitor or pramlintide.
7. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or
compliance with the protocol.
8. Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary
thyroid carcinoma (MTC).
9. History of pancreatitis (acute or chronic).
10. History of major surgical procedures involving the stomach potentially affecting absorption of
trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
11. Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart
failure.
12. Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening.
13. Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or
transient ischaemic attack within the past 60 days prior to screening.
14. Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment
(corresponding to eGFR <30 mL/min/1.73 m2
).
15. History or presence of malignant neoplasms within the last 5 years (except basal and
squamous cell skin cancer and carcinoma in situ).
16. History of diabetic ketoacidosis.
For an eligible subject, all exclusion criteria must be answered "no".
1. Known or suspected hypersensitivity to the trial product or related products.
2. Previous participation in this trial. Participation is defined as signed informed consent.
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
potential and not using adequate contraceptive methods (adequate contraceptive measures as
required by local regulation or practice. Local country regulations or practices are specified in
section 8 of the protocol).
4. Receipt of any investigational medicinal product within 90 days before screening.
For Brazil only: Participation in other clinical trials within one year prior to screening unless there
is a direct benefit to the research subject at the investigator´s discretion.
5. Participation in another clinical trial of an investigational medicinal product. Participation in a
clinical trial which evaluate stent(s) is allowed.
6. Current or previous (within 90 days prior to screening) treatment with any GLP-1 receptor
agonist, DPP-4 inhibitor or pramlintide.
7. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or
compliance with the protocol.
8. Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary
thyroid carcinoma (MTC).
9. History of pancreatitis (acute or chronic).
10. History of major surgical procedures involving the stomach potentially affecting absorption of
trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
11. Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart
failure.
12. Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening.
13. Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or
transient ischaemic attack within the past 60 days prior to screening.
14. Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment
(corresponding to eGFR <30 mL/min/1.73 m2
).
15. History or presence of malignant neoplasms within the last 5 years (except basal and
squamous cell skin cancer and carcinoma in situ).
16. History of diabetic ketoacidosis.
The Estimated Number of Participants
-
Taiwan
75 participants
-
Global
3176 participants
