A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

Phase 3

• Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

• Registration Number: CTRI/2019/08/020910
• Lead Sponsor: ovo Nordisk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male or female, age =50 years 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).a

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. =50% stenosis in coronary artery documented by cardiac catheterisation or CT

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. =50% stenosis in carotid artery documented by X-ray angiography, MR

angiography, CT 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 a =50% stenosis in peripheral artery (excluding

carotid) documented by X-ray angiography, MR angiography, CT 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 b

Exclusion Criteria

1. Known or suspected hypersensitivity to trial product or related products.

2. Previous participation in this trial. Participation is defined as randomisation.

3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing

potential and not using a highly effective contraceptive method.

4. Participation in any clinical trial of an approved or non-approved investigational medicinal

product within 30 days before screening.

5. Any disorder, which in the investigator’s opinion might jeopardise patient’s safety or

compliance with the protocol.

6. 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

7. Planned coronary, carotid or peripheral artery revascularisation.

8. Heart failure presently classified as being in New York Heart Association (NYHA) Class IV.

9. Treatment with any GLP-1 receptor agonist (RA) within 30 days before screening.

10. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus

examination performed within the past 90 days prior to screening or in the period between

screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a

digital fundus photography camera specified for non-dilated examination.

11. Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal

and squamous cell skin cancer and any carcinoma in-situ is allowed.

12. Personal or first degree relative(s) history of MEN2 or MTC.

13. End stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis.

14. History of major surgical procedures involving the stomach or small intestine potentially

affecting absorption of drugs and or nutrients, as judged by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified