A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Semaglutide; Insulin aspart; Insulin glargine U100
Intervention description: Subjects will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) with a dose of 0.25 mg. The dose should be increased after four weeks to 0.5 mg semaglutide. After 4 more weeks the dose can be increased to 1.0 mg semaglutide if the study doctor decides and further dose adjusted throughout the study.; Subjects should initiate treatment with 4U of Insulin aspart (s.c. injections) before each main meal, three times daily (TID). The dose will be adjusted individually based on pre-prandial and bedtime self measured plasma glucose (SMPG) from the preceding 3 days; Run-in period: Subjects will receive s.c. injections of IGlar U100 OD in accordance with the approved local label of IGlar U100. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.0-6.9 mmol/L)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2274.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily
      as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will
      either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which
      treatment the participant get is decided by chance. Insulin glargine is taken once a day and
      semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three
      medicines come in pre-filled pens for injection under the skin. The study will last for about
      71 weeks. If participant's blood sugar gets under or over certain values participant will
      only participate in 14 weeks. The study doctor will inform the participant about this. The
      participant will have 15 clinic visits and 22 phone calls with the study doctor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age greater than or equal to 18 years at the time of signing informed
             consent

          -  Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of
             screening

          -  Treated with basal insulin once daily or twice daily for greater than or equal to 90
             days prior to the day of screening

          -  Stable daily dose for 90 days prior to the day of screening of the following
             anti-diabetic drugs or combination regimens: Any metformin formulations (greater than
             or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective
             dose documented in subject's medical record), alone or in combination (including
             fixed-dose drug combination) with up to one additional of the following oral
             antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or
             alpha-glucosidase inhibitors

          -  Glycated haemoglobin (HbA1c) of greater than 7.5% to less than or less than or equal
             to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol)

        Exclusion Criteria:

          -  History or presence of pancreatitis (acute or chronic)

          -  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 Class IV

          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of
             screening

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria within the past 90 days prior to the day of
             screening. However, short term bolus insulin treatment for a maximum of 14 days prior
             to the day of screening is allowed

          -  Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by
             a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist
             or an equally qualified health care provider (for example, optometrist) within the
             past 90 days prior to run-in