Diabetes Mellitus, Type 2 MedDRA version: 17.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: semaglutide
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: semaglutide
CAS Number: 910463682
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men and women with type 2 diabetes mellitus. - Age =50 years at screening and clinical evidence of cardiovascular disease or age =60 years at screening and subclinical evidence of cardiovascular disease. - Anti-diabetic drug naïve, or treated with one or two OAD(s), or treated with human NPH insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OAD(s). - HbA1c =7.0% at screening. 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 1630 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1630
Exclusion criteria
Exclusion criteria: - Type 1 diabetes mellitus. - Use of GLP-1 receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening. - Use of any DPP-IV inhibitor within 30 days prior to screening. - 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. - 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. - History of chronic pancreatitis or idiopathic acute pancreatitis. - Acute coronary or cerebro-vascular event within 90 days prior to randomisation. - Currently planned coronary, carotid or peripheral artery revascularisation. - Chronic heart failure NYHA class IV. - Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma. - Personal history of non-familial medullary thyroid carcinoma. - Screening calcitonin =50 ng/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Time from randomisation to first occurrence of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.;Timepoint(s) of evaluation of this end point: Time from randomisation to first occurrence of a major adverse cardiovascular event (MACE).;Secondary Objective: To assess the long-term safety and efficacy of semaglutide 0.5 mg and 1.0 mg once weekly compared to placebo, both added on to standard of care, in adults with type 2 diabetes at high risk for cardiovascular events.;Main Objective: To confirm that treatment with semaglutide does not result in an unacceptable increase in cardiovascular risk as compared to placebo in adults with type 2 diabetes. This is done by demonstrating that the upper limit of the two-sided 95% confidence interval (CI) of the hazard ratio for semaglutide versus placebo is less than 1.8 when comparing time to first occurrence of a major adverse cardiovascular event (MACE). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Time from randomisation to first occurrence of an expanded composite cardiovascular outcome. 2 - Time from randomisation to each individual component of the expanded composite cardiovascular outcome. 3 - Time from randomisation to first occurrence of all-cause death, non-fatal MI, or non-fatal stroke. 4 - Change from baseline to last assessment during the treatment period in other treatment outcomes, including HbA1c, fasting plasma glucose, body weight, lipid profile, urinary albumin to creatinine ratio, vital signs, hypoglycaemic events, adverse events, antisemaglutide antibodies and patient reported outcome (PRO). ; Timepoint(s) of evaluation of this end point: 1. Time from randomisation up to end of Follow-up (up to max. 148 weeks) 2. Time from randomisation up to end of Follow-up (up to max. 148 weeks) 3. Time from randomisation up to end of Follow-up (up to max. 148 weeks) 4. From randomisation to end of treatment (up to max. 143 weeks) | — |
Countries
Algeria, Argentina, Australia, Brazil, Bulgaria, Canada, Denmark, European Union, Germany, India, Israel, Italy, Malaysia, Mexico, Poland, Russian Federation, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed