Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; insulin glargine
Intervention description: Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.; Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.
Intervention MeSH terms: Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1089.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of
      the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide
      versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in
      insulin-naïve subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years or older at the time of signing informed consent

          -  Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment
             with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated
             dose and SU half of maximum allowed dose according to national label or higher) for at
             least 90 days before screening. Stable is defined as unchanged medication and
             unchanged dose

          -  HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

        Exclusion Criteria:

          -  Female who is pregnant, breast-feeding or intends to become pregnant or of
             childbearing potential not using adequate contraceptive method (adequate contraceptive
             measures as required by local regulation or practice) throughout the trial including
             the 5 week follow-up period

          -  Any disorder which, in the opinion of the Investigator might jeopardise subject's
             safety or compliance with the protocol

          -  Treatment with any glucose lowering agent(s) other than stated in the inclusion
             criteria in a period of 90 days before screening. An exception is short-term treatment
             (7 days or less in total) with insulin in connection with intercurrent illness

          -  History of chronic or idiopathic acute pancreatitis

          -  Screening calcitonin value greater than or equal to 50 ng/L

          -  Personal or family history of medullary thyroid carcinoma or multiple endocrine
             neoplasia syndrome 2

          -  Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less
             than 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4
             variable version)

          -  Acute coronary or cerebrovascular event within 90 days before randomisation

          -  Heart failure, New York Heart Association Class IV

          -  Known proliferative retinopathy or maculopathy requiring acute treatment according to
             the opinion of the investigator

          -  Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer
             or squamous cell skin cancer)

          -  Mental inability, unwillingness or language barrier precluding adequate understanding
             of or compliance with study procedures