A trial to Investigate the cardiovascular Safety of Oral Semaglutide in the Subjects with Type 2 Diabetes.

Phase 3

Completed

• Conditions: Health Condition 1: null- Type 2 DiabetesHealth Condition 2: E11- Type 2 diabetes mellitus

• Registration Number: CTRI/2017/02/007841
• Lead Sponsor: ovo Nordisk India Private Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-09-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 201

Inclusion Criteria

1. Informed consent obtained before any trial-related activities. Trial-related activities are any

procedures that are carried out as part of the trial, including activities to determine suitability

for the trial.

2. Male or female diagnosed with type 2 diabetes.

3. Age >= 50 years at screening and at least one of the below conditions:

a. prior myocardial infarction

b. prior stroke or transient ischaemic attack (TIA)

c. prior coronary, carotid or peripheral arterial revascularisation

d. > 50% stenosis on angiography or imaging of coronary, carotid or lower

extremity arteries

e. history of symptomatic coronary heart disease documented by e.g. positive

exercise stress test or any cardiac imaging or unstable angina pectoris with ECG

changes

f. asymptomatic cardiac ischaemia documented by positive nuclear imaging test or

exercise test or stress echo or any cardiac imaging

g. chronic heart failure New York Heart Association (NYHA) class II-III

h. moderate renal impairment (corresponding to an estimated glomerular filtration

rate (eGFR) between 30-59 mL/min/1.73 m2)

or

Age >= 60 years at screening and at least one of the below risk factors:

i. microalbuminuria or proteinuria

j. hypertension and left ventricular hypertrophy by ECG or imaging

k. left ventricular systolic or dysfunction by imaging l. ankle/brachial index < 0.9

Exclusion Criteria

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

2. Previous participation in this trial. Participation is defined as signed informed consent. 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing

potential and not using adequate contraceptive methods (adequate contraceptive measures as

required by local regulation or practice. Local country regulations or practices are specified

in section 8 of the protocol).

4. Receipt of any investigational medicinal product within 90 days before screening.

For Brazil only: Participation in other clinical trials within one year prior to screening

unless there is a direct benefit to the research subject at the investigator´s discretion.

5. Participation in another clinical trial of an investigational medicinal product. Participation in

a clinical trial which evaluate stent(s) is allowed.

6. Current or previous (within 90 days prior to screening) treatment with any GLP-1 receptor

agonist, DPP-4 inhibitor or pramlintide.

7. Any disorder, which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or

compliance with the protocol.

8. Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary

thyroid carcinoma (MTC).

9. History of pancreatitis (acute or chronic).

10. 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).

11. Subjects presently classified as being in New York Heart Association (NYHA) Class IV

heart failure.

12. Planned coronary, carotid or peripheral artery revascularisation known on the day of

screening.

13. Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or

transient ischaemic attack within the past 60 days prior to screening.

14. Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment

(corresponding to eGFR <30 mL/min/1.73 m2).

15. History or presence of malignant neoplasms within the last 5 years (except basal and

squamous cell skin cancer and carcinoma in situ).

16. History of diabetic ketoacidosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified