A heart disease study of semaglutide in patients with type 2 diabetes

Phase 1

• Conditions: Type 2 diabetes; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-003141-42-IT
• Lead Sponsor: OVO NORDISK. S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 9642

Inclusion Criteria

1. Male or female, age 50 years or older at the time of signing informed consent.
2. Diagnosed with type 2 diabetes mellitus
3. HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive) (latest available and no more than 30 days old local laboratory assessment based on medical records or point of care measurement)
4. At least one of the below conditions (a-d):
a) Coronary heart disease defined as at least one of the following:
i. Prior myocardial infarction
ii. Prior coronary revascularisation procedure
iii. Equal to or above 50% stenosis in coronary artery documented by cardiac catheterisation, computerizede tomography coronary angiography
iv. Coronary heart disease with ischaemia documented by stress test with any imaging modality
b) Cerebrovascular disease defined as at least one of the following:
i. Prior stroke
ii. Prior carotid artery revascularisation procedure
iii. Equal to or above 50% stenosis in carotid artery documented by X-ray angiography, magnetic resonance angiography, computerizede tomography angiography or Doppler ultrasound
c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following:
i. Intermittent claudication with an Ankle-brachial index (ABI) < 0.85 at rest
ii. Intermittent claudication with an equal to or above 50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, magnetic resonance angiography, computerizede tomography angiography or Doppler ultrasound
iii. Prior peripheral artery (excluding carotid) revascularization procedure
iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis)
d) Chronic kidney disease defined as:
i. eGFR < 60 mL/min/1.73 m2 (Based on medical records using latest available and no more than 6 months old assessment).
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 3857
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5785

Exclusion Criteria

1. Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack (TIA) within the past 60 days prior to the day of screening
2. Planned coronary, carotid or peripheral artery revascularisation.
3. Heart failure presently classified as being in New York Heart Association (NYHA) Class IV.
4. Treatment with any GLP-1 receptor agonist (RA) within 30 days before screening.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that oral semaglutide lowers the risk of major adverse cardiovascular events compared to placebo, both added to standard of care in patients with type 2 diabetes and at high risk of cardiovascular events.;Secondary Objective: To compare the effects of oral semaglutide versus placebo, both added to standard of care in patients with type 2 diabetes and at high risk of cardiovascular events with regards to:<br>-Chronic kidney disease<br>-Cardiovascular events<br>-Peripheral artery disease<br>-Glycaemic control and body weight<br>-Safety;Primary end point(s): Time to first occurrence of MACE, a composite endpoint consisting of: <br>-CV death<br>-non-fatal myocardial infarction <br>-non-fatal stroke.;Timepoint(s) of evaluation of this end point: From randomisation (week 0) to end-of-trial (up to 61 months or more) (trial is event driven).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to first occurrence of a composite endpoint consisting of: <br>-Cardiovascular death<br>-Renal death<br>-Onset of persistent = 50% reduction in eGFR (CKD-EPI) (compared with baseline)<br>-Onset of persistent eGFR (CKD-EPI) < 15 mL/min/1.73 m2<br>-Initiation of chronic renal replacement therapy (dialysis or kidney transplantation); Time to occurrence of Cardiovascular Death; Time to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: <br>-acute limb ischemia hospitalisation<br>-chronic limb ischemia hospitalisation;Timepoint(s) of evaluation of this end point: From randomisation (week 0) to end-of-trial (up to 61 months or more) (the trial is event driven).; From randomisation (week 0) to end-of-trial (up to 61 months or more) (the trial is event driven).; From randomisation (week 0) to end-of-trial (up to 61 months or more) (the trial is event driven).