Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Semaglutide; Liraglutide
Intervention description: Dose gradually increased to 1.0 mg, given s.c. (under the skin), once-weekly for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs (tablets), if any; Dose gradually increased to 1.2 mg, given s.c. once-daily for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs, if any
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 577.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is conducted in Europe. The aim of the study is to compare the effect of
      semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg
      once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes.
      The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at
      the clinic and 3 phone calls with the study doctor. At the visits, participants will have a
      number of tests, for example: general health checks, blood samples, heart and eye checks etc.
      Participants will also fill in some forms about their health and satisfaction with their
      diabetes treatment.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female, age 18 years or older at the time of signing informed
        consent - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol)
        (both inclusive) - Stable daily dose(s) including any of the following anti-diabetic
        drug(s) or combination regimens 90 days prior to the day of screening: a) Biguanides
        (metformin above or equal to 1500 mg or maximum tolerated dose documented in the subject's
        medical record). b) Sulphonylureas (above or equal to half of the maximum approved dose
        according to local label or maximum tolerated dose as documented in subject medical
        record). c) SGLT-2 inhibitors (above or equal to half of the maximum approved dose
        according to local label or maximum tolerated dose as documented in subject medical record)
        Exclusion Criteria: - Family or personal history of multiple endocrine neoplasia type 2 or
        medullary thyroid carcinoma. Family is defined as a first degree relative - History or
        presence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis - 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) value of below 30
        ml/min/1.73 sqm as defined by KDIGO 2012 classification - Impaired liver function, defined
        as ALT above or equal to 2.5 times upper normal limit at screening - Proliferative
        retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or
        dilated fundoscopy performed within the past 90 days prior to randomisation