A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Oral semaglutide; Placebo
Intervention description: Tablets to be taken once-daily for 26 weeks; Tablets to be taken once-daily for 26 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Enrollment: 521.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and
      placebo (a dummy medicine). Researchers will test semaglutide to see how well it works
      compared to placebo. The study will also test if semaglutide is safe. Participants will
      either get semaglutide or placebo - which treatment is decided by chance. Participants will
      get 1 tablet a day to take with up to half a glass of water. Participants must take the
      tablet first thing in the morning on an empty stomach. After taking the tablet, participants
      must not eat or drink anything for at least 30 minutes. After the 30 minutes, participants
      can have their first meal of the day and take any other medicines they may need. The study
      will last for about 8 months (36 weeks). Participants will have 9 clinic visits and 2 phone
      calls with the study doctor. At all 9 of the clinic visits, participants will have blood
      samples taken. At 5 of the clinic visits, participants must arrive fasting. This means they
      cannot eat for 8 hours before the visit. It is fine to drink water up to 2 hours before the
      visit. This is for some of the blood samples that will be taken at the visit. Women cannot
      take part if pregnant, breastfeeding or planning to become pregnant during the study period.
    

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 Algeria only: Male or female, age above or equal to 19 years at the time of signing the
        informed consent.

        For Taiwan only: Male or female, age above or equal to 20 years at the time of signing the
        informed consent.

          -  Diagnosed with type 2 diabetes mellitus

          -  HbA1c between 7.0 -10.0% (53-86 mmol/mol) (both inclusive).

        Exclusion Criteria:

          -  - Female who is pregnant, breast-feeding or intends to become pregnant or is of
             child-bearing potential and not using an highly effective contraceptive method.

          -  Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary
             thyroid carcinoma (MTC). Family is defined as a first degree relative.

          -  History or presence 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, hospitalization 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.

          -  Renal impairment measured as estimated glomerular filtration rate (eGFR) below 60
             mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration
             formula(CKD-EPI).

          -  Subjects with alanine aminotransferase (ALT) above 2.5 x upper limit of the normal
             (ULN).

          -  Presence or history of malignant neoplasms within the past 5 years prior to the day of
             screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.