Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Semaglutide; Standard of care
Intervention description: Participants will be prescribed commercially available semaglutide s.c. and will be instructed to initiate treatment with semaglutide s.c. according to the approved label. The study doctor will determine the intended maintenance dose of semaglutide, as well as changes to the maintenance dose thereafter.; Participants will receive standard of care, defined as commercially available oral or injectable antidiabetic medication other than semaglutide. Participants will be prescribed and instructed to initiate commercially available antidiabetic medication according to the approved label and, if relevant for the specific antidiabetic medication, adjusted at the discretion of the study doctor.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1278.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to compare the effects of semaglutide (Ozempic®) with the
      effects of other treatments for type 2 diabetes in a normal practice setting. The participant
      will be assigned by chance (like flipping a coin) to one of the following treatment groups:
      Group 1: semaglutide (Ozempic®) (by injection into skin) Group 2: standard of care
      antidiabetic medication (oral or injectable). The participant has an equal chance of being in
      either of the treatment groups. Neither the participant nor the study doctor or study staff
      will be able to pick which group the participant is in, but the participant will know which
      study drug the participant has been assigned to. The study doctor will provide the
      participant with a prescription for the study diabetes medication based on the treatment
      group the participant is assigned. The participation will last about 2 years.
    

Eligibility criteria:

        Inclusion Criteria:-

          -  Informed consent obtained before any study-related activities. Study-related
             activities are any procedures that are carried out as part of the study.

          -  Male or female, age 18 years or older at the time of signing informed consent.

          -  Type 2 diabetes mellitus diagnosis.

          -  Treatment with either 1 or 2 oral antidiabetic medications.

          -  Current member of a commercial or Medicare health plan with pharmacy benefits.

          -  Recorded HbAlc value within the last 90 days prior to randomization.

          -  Further intensification with an additional antidiabetic oral or injectable medication
             is indicated to achieve glycemic target at the discretion of the study physician
             according to approved labelling.

        Exclusion Criteria:

          -  Previous randomization in this study

          -  Treatment with more than 2 oral antidiabetic medications, oral semaglutide, or any
             injectable medication in a period of 30 days before the day of eligibility assessment.
             Temporary/emergency use of any type of insulin is allowed, as is prior insulin
             treatment for gestational diabetes.

          -  Contraindications to semaglutide according to the Food and Drug Administration
             approved label.

          -  Female who is pregnant, breastfeeding or intends to become pregnant

          -  Participation in another clinical trial.