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

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 18.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-003563-10-NL
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-15
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3176

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified