Health Condition 1: null- Diabetes Mellitus, Type 2 Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Semaglutide 0.5 mg: Drug: semaglutide,Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administer
Sponsors
Novo Nordisk AS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women with type 2 diabetes mellitus 2. Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease 3.Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs 4. HbA1c above or equal to 7.0% at screening
Exclusion criteria
Exclusion criteria: 1. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening 2. History of chronic pancreatitis or idiopathic acute pancreatitis 3. An acute coronary or cerebro-vascular event within the previous 14 days from Visit 2 (week 0) 4. Currently planned coronary, carotid or peripheral artery revascularisation 5. Chronic heart failure New York Heart Association (NYHA) class IV 6. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma 7. Personal history of non-familial medullary thyroid carcinoma 8. Screening calcitonin above or equal to 50 ng/L 9. Type 1 diabetes mellitus 10. Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening 11. Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening 12. Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomisation to first occurrence of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.Timepoint: Time from randomisation up to end of follow-up (up to max. 148 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Change from baseline to last assessment during the treatment period in other treatment outcomes: patient reported outcome (PRO). Timepoint: Week 0, up to week 143 ;â?¢Incidence during the treatment period in other treatment outcomes: adverse events. Timepoint: Weeks 0-143 ;â?¢Incidence during the treatment period in other treatment outcomes: hypoglycaemic events. Timepoint: Week 0 - 143 ;â?¢Change from baseline to last assessment during the treatment period in other treatment outcomes: body weight. Timepoint: Week 0, up to week 143 ;â?¢Change from baseline to last assessment during the treatment period in other treatment outcomes: fasting plasma glucose. Timepoint: Week 0, up to week 143 ;â?¢Change from baseline to last assessment during the treatment period in other treatment outcomes: glycosylated haemoglobin (HbA1c). Timepoint: Week 0, up to week 143 ;â?¢Occurrence during the treatment period in other treatment outcomes: anti-semaglutide antibodies.Timepoint: Weeks 0-143 ;â?¢Time from randomisation to each individual component of the expanded composite cardiovascular outcome.Timepoint: Time from randomisation up to end of follow-up (up to max. 148 weeks) ;â?¢Time from randomisation to first occurrence of an expanded composite cardiovascular outcome. Timepoint: Time from randomisation up to end of follow-up (up to max. 148 weeks) | — |
Countries
Argentina, Australia, Bulgaria, Canada, Germany, India, Israel, Italy, Poland, Russian Federation, Spain, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd
Outcome results
None listed