A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes - PIONEER 6 – Cardiovascular outcomes

ovo Nordisk A/S0 sites3,176 target enrollmentMarch 15, 2016

Overview

No summary available.

Registry

who.int

Start Date

March 15, 2016

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Male or female diagnosed with type 2 diabetes
•2\. Age \= 50 years at screening and presence of cardiovascular disease, or age \= 60 years at screening and presence of at least one cardiovascular risk factor
•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 1588
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 1588

•1\. Current or previous (within 90 days prior to screening) treatment with any GLP\-1 receptor agonist, DPP\-4 inhibitor or pramlintide
•2\. Family or personal history of multiple endocrine neoplasia type 2 (MEN 2\) or medullary thyroid carcinoma (MTC)
•3\. History of pancreatitis (acute or chronic)
•4\. 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)
•5\. Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart failure
•6\. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
•7\. Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
•8\. Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR \<30 mL/min/1\.73 m^2\)
•9\. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)