A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted globally. The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes.

Key facts

Study ID

NCT02692716

Run by

Novo Nordisk A/S

People needed

3183

Starts

2017-01-17

Expected to finish

2018-09-25

Last updated by the study team

2022-07-20

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Novo Nordisk Investigational Site — Searcy, Arkansas, United States
• Novo Nordisk Investigational Site — Concord, California, United States
• Novo Nordisk Investigational Site — Huntington Beach, California, United States
• Novo Nordisk Investigational Site — La Jolla, California, United States
• Novo Nordisk Investigational Site — La Mesa, California, United States
• Novo Nordisk Investigational Site — Lancaster, California, United States
• Novo Nordisk Investigational Site — Monterey, California, United States
• Novo Nordisk Investigational Site — San Diego, California, United States
• Novo Nordisk Investigational Site — San Ramon, California, United States
• Novo Nordisk Investigational Site — Ventura, California, United States
• Novo Nordisk Investigational Site — Boca Raton, Florida, United States
• Novo Nordisk Investigational Site — New Port Richey, Florida, United States
• Novo Nordisk Investigational Site — Roswell, Georgia, United States
• Novo Nordisk Investigational Site — Savannah, Georgia, United States
• Novo Nordisk Investigational Site — Honolulu, Hawaii, United States
• Novo Nordisk Investigational Site — Springfield, Illinois, United States
• Novo Nordisk Investigational Site — Indianapolis, Indiana, United States
• Novo Nordisk Investigational Site — Michigan City, Indiana, United States
• Novo Nordisk Investigational Site — Muncie, Indiana, United States
• Novo Nordisk Investigational Site — Council Bluffs, Iowa, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Louisville, Kentucky, United States
• Novo Nordisk Investigational Site — Monroe, Louisiana, United States
• Novo Nordisk Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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