A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes (PIONEER 6)
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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 [ Time Frame: From randomisation up to 19 months ]
Secondary Outcome Measures
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 Frame: From randomisation up to 19 months ]
Time from randomisation to first occurrence of each of the individual components in the expanded composite cardiovascular endpoint [ Time Frame: From randomisation up to 19 months ]
Time from randomisation to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction or non-fatal stroke [ Time Frame: From randomisation up to 19 months ]
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Ages Eligible for Study:
50 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female diagnosed with type 2 diabetes
Age at least 50 years at screening and presence of cardiovascular disease, or age at least 60 years at screening and presence of at least one cardiovascular risk factor
Current or previous (within 90 days prior to screening) treatment with any GLP-1 (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor or pramlintide
Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
History of pancreatitis (acute or chronic)
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)
Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart failure
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73 m^2)
History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)