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SOUL - Semaglutide cardiovascular outcomes trial in patients with type 2 diabetes

NCT03914326

SOUL - Semaglutide cardiovascular outcomes trial in patients with type 2 diabetes

Associated Conditions

Type 2 Diabetes

Principal Investigator

Sponsor

NOVO NORDISK

We are doing this study to look at whether the study medicine (semaglutide) has a positive effect on heart disease in patients that have type 2 diabetes. This will be done by comparing the study medicine (semaglutide) against placebo on the effect on heart disease.

Study Duration: Up to 5 years

Study Commitment:

• One Screening Visit (Informed consent discussion and signing, pregnancy test (if applicable), blood work, vital sign measurements, and questions about your medical history)

• 25 visits to the clinic (vital sign measurements, physical examination, blood work)

• 1 phone call follow up

Age: >50 years old

Sex: Male & Female

Conditions/Eligibility:

• Type 2 diabetes

• Not currently being treated with a GLP-1 drug for blood sugar control

• Pre-existing cardiovascular disease (prior heart attack, prior stroke, poor circulation or amputation, mild to moderate kidney disease)

Study Procedures:

• Physical exam with a physician/physician assistant

• Dilated eye examination with an ophthalmologist

• Vital sign measurement (blood pressure, pulse)

• Height and weight measurement

• Blood draws and urine collections

• Collection of medical history and medication history

• Pregnancy test (females only)

Compensation: Up to a maximum of $2400.00