EUCTR2015-003563-10-NLActive, not recruitingPhase 1
A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes - PIONEER 6 – Cardiovascular outcomes
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 3,176
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Investigators
Similar Trials
Active, not recruiting
Phase 1
A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetesDiabetes Mellitus, Type 2EUCTR2015-003563-10-ROovo Nordisk A/S3,183
Active, not recruiting
Phase 1
A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetesDiabetes Mellitus, Type 2EUCTR2015-003563-10-ITOVO NORDISK. S.P.A.3,183
Active, not recruiting
Phase 1
A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetesDiabetes Mellitus, Type 2EUCTR2015-003563-10-GBovo Nordisk A/S3,183
Active, not recruiting
Phase 1
A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetesMedDRA version: 19.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2015-003563-10-ESovo Nordisk A/S3,176
Completed
Phase 3
A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetesDiabetes Mellitus type 210018424DiabetesNL-OMON43437ovo Nordisk75