NL-OMON43437
Completed
Phase 3
A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes - PIONEER6 - Cardiovascular outcomes
ovo Nordisk0 sites75 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- ovo Nordisk
- Enrollment
- 75
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Male or female diagnosed with type 2 diabetes (T2D)
- •\-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
Exclusion Criteria
- •\-Current or previous (within 90 days prior to screening) treatment with any GLP\-1 receptor agonist, DPP\-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 \<30 mL/min/1\.73 m2\)
- •\-History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
- •\-Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
Outcomes
Primary Outcomes
Not specified
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