A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2015-003563-10-IT
- Lead Sponsor
- OVO NORDISK. S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3183
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: 1
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
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
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to confirm that treatment with oral semaglutide does not result in an unacceptable increase in cardiovascular risk compared to placebo (rule out 80% excess risk) in subjects with type 2 diabetes at high risk of cardiovascular events;Secondary Objective: The secondary objectives are to compare the efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes at high risk of cardiovascular events;Primary end point(s): The primary endpoint is time from randomisation to first occurrence of a major adverse cardiovascular event (MACE) composite endpoint consisting of: cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.;Timepoint(s) of evaluation of this end point: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Time from randomisation to first occurrence of an expanded<br>composite cardiovascular endpoint consisting of: cardiovascular death,<br>non-fatal myocardial infarction, non-fatal stroke, unstable angina<br>requiring hospitalisation or hospitalisation for heart failure<br>2. Time from randomisation to first occurrence of each of the individual<br>components in the expanded composite cardiovascular endpoint<br>3. Time from randomisation to first occurrence of a composite endpoint<br>consisting of: all-cause death, non-fatal myocardial infarction or nonfatal<br>stroke;Timepoint(s) of evaluation of this end point: All endpoints: Maximum treatment duration is dependent on event rates<br>and is estimated to be no longer than 19 months