A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus type 2; 10018424

• Registration Number: NL-OMON43437
• Lead Sponsor: ovo Nordisk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 75

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
photography or dilated fundoscopy performed within 90 days prior to screening or within the
period between screening and randomisation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is time from randomisation to first occurrence of a MACE<br /><br>composite endpoint consisting of: cardiovascular death, non-fatal myocardial<br /><br>infarction or non-fatal stroke.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key secondary endpoints:<br /><br>* Time from randomisation to first occurrence of an expanded composite<br /><br>cardiovascular<br /><br>endpoint consisting of: cardiovascular death, non-fatal myocardial infarction,<br /><br>non-fatal<br /><br>stroke, unstable angina requiring hospitalisation or hospitalisation for heart<br /><br>failure<br /><br>* Time from randomisation to first occurrence of each of the individual<br /><br>components in the<br /><br>expanded composite cardiovascular endpoint<br /><br>* Time from randomisation to first occurrence of a composite endpoint<br /><br>consisting of: all-cause<br /><br>death, non-fatal myocardial infarction or non-fatal stroke</p><br>