Overview

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

Status:
Completed

Trial end date:
2018-09-25

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novo Nordisk A/S

Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)