Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; semaglutide; placebo
Intervention description: 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. Administered subcutaneously (s.c., under the skin); Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin); Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3297.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and
      other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is
      event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the
      accrual of major adverse cardiovascular events (MACE) in this trial and the remaining
      research programme. The incidence of MACE will be monitored throughout the trial which will
      be terminated according to plan when pre-specified stopping criteria are met.
    

Eligibility criteria:

        Inclusion Criteria: - Men and women with type 2 diabetes mellitus - 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 - 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 - HbA1c
        above or equal to 7.0% at screening Exclusion Criteria: - Type 1 diabetes mellitus - Use of
        glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or
        pramlintide within 90 days prior to screening - Use of any dipeptidyl peptidase 4 (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 New York Heart Association (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 above or equal to 50 ng/L