Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; liraglutide; placebo
Intervention description: Oral semaglutide once-daily.; Subcutaneous (s.c.) injection once-daily.; Placebo once-daily.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 711.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to investigate efficacy and safety
      of oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes
      Mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  Male or female, age above or equal to 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 type 2 diabetes mellitus for at least 90 days prior to day of
             screening.

          -  HbA1c (glycosylated haemoglobin) of 7.0-9.5 % (53-80.3 mmol/mol) (both inclusive)

          -  Stable daily dose of metformin (above or equal to 1500 mg or maximum tolerated dose as
             documented in the subject medical record) alone or in combination with a stable daily
             dose of a SGLT-2 (sodium-glucose co-transporter-2) inhibitor for at least 90 days
             prior to day of screening (fixed-dose combinations are allowed)

        Exclusion Criteria:

          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of
             child-bearing potential and not using an adequate contraceptive method (adequate
             contraceptive measure as required by local regulation or practice).For certain
             specific countries: Additional specific requirements apply

          -  Any disorder, which in the investigator's opinion might jeopardise subject's safety or
             compliance with the protocol

          -  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 and potentially affecting
             absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,
             gastric bypass surgery)

          -  Any of the following: myocardial infarction (MI), stroke or hospitalisation for
             unstable angina 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

          -  Subjects with ALT (alanine aminotransferase) above 2.5 × upper normal limit (UNL)

          -  Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60
             mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula
             (CKD-EPI)

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria in a period of 90 days before the day of screening.
             An exception is short-term insulin treatment for acute illness for a total of below or
             equal to 14 days

          -  Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
             photography or dilated fundoscopy performed within 90 days prior to randomisation

          -  History or presence of malignant neoplasms within the last 5 years (except basal and
             squamous cell skin cancer and carcinoma in situ)

          -  History of diabetic ketoacidosis