Health Condition 1: null- Type 2 Diabetes Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Drug: semaglutide
: For oral use once daily, 19 months
Control Intervention1: Drug: placebo
: For oral use once daily, 19 months
Sponsors
Novo Nordisk India Private Ltd
Eligibility
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "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 [ Time Frame: From randomisation up to 19 months ] [ Designated as safety issue: No ] " Timepoint: 1 year 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from randomisation to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction or non-fatal stroke [ Time Frame: From randomisation up to 19 months ] [ Designated as safety issue: No ]Timepoint: Time Frame: From randomisation up to 19 months;From randomisation to first occurrence of an expanded composite cardiovascular endpoint consisting of: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospitalisation or hospitalisation for heart failure [ Time Frame: From randomisation up to 19 months ] [ Designated as safety issue: No ]Timepoint: Time Frame: From randomisation up to 19 months;Time from randomisation to first occurrence of each of the individual components in the expanded composite cardiovascular endpoint [ Time Frame: From randomisation up to 19 months ] [ Designated as safety issue: No ]Timepoint: Time Frame: From randomisation up to 19 months | — |
Countries
Algeria, Argentina, Brazil, Canada, Denmark, Germany, India, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Romania, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd.
Outcome results
None listed