Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; empagliflozin
Intervention description: Oral administration once-daily.; Oral administration once-daily.
Intervention MeSH terms: Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 822.0
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 Empagliflozin 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

          -  Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening

          -  HbA1c (glycosylated haemoglobin) of 7.0-10.5 % (53-91 mmol/mol) (both inclusive)

          -  Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose as
             documented in the subject medical record) at least 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 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 or Medullary Thyroid
             Carcinoma

          -  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 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 Class IV

          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of
             screening

          -  Subjects with ALT (alanine aminotransferase) above 2.5 x upper normal limit

          -  Renal impairment defined as Estimated Glomerular Filtration Rate 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