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

Phase 1

• Conditions: Diabetes Mellitus, Type 2; 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-BE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-24
• Last Update Posted: 7 September 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, computerized 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, computerized 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) below 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, computerized 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 below 60 mL/min/1.73 m^2 (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 within the past 60 days prior to the day of screening
2. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
3. Heart failure presently classified as being in New York Heart Association Class IV
4. Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening

Study & Design

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