Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; sitagliptin; placebo
Intervention description: Oral administration once-daily; Oral administration once-daily; Oral administration once-daily
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1864.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to investigate efficacy and
      long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age at least 18 years at the time of signing informed consent For
             Japan only: Male or female, age at least 20 years at the time of signing informed
             consent

          -  Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days prior to day of
             screening

          -  HbA1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol) (both inclusive).

          -  Stable daily dose of metformin (equal or above 1500 mg or maximum tolerated dose as
             documented in subject medical record) alone or in combination with SU (= half of the
             maximum approved dose according to local label or maximum tolerated dose as documented
             in subject medical record) within 90 days prior to the day of screening

        Exclusion Criteria:

          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of
             child-bearing potential and not using adequate contraceptive methods (adequate
             contraceptive measures as required by local regulation or practice). For certain
             specific countries: Additional specific requirements apply

          -  Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary
             Thyroid Carcinoma (MTC)

          -  History of pancreatitis (acute or chronic)

          -  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)

          -  Any of the following: myocardial infarction, stroke or hospitalization for unstable
             angina and/or transient ischaemic attack within the past 180 days prior to the day of
             screening

          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV.

          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of
             screening.

          -  Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60
             mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

          -  History or presence of malignant neoplasms within the last 5 years (except basal and
             squamous cell skin cancer and in-situ carcinomas)