Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity
Condition: Obesity; Overweight
MeSH terms: Obesity; Overweight
Intervention: Semaglutide 1.0 mg; Semaglutide 2.4 mg; Placebo I (Semaglutide); Placebo II (Semaglutide)
Intervention description: Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.; Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.; S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.; S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1210.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will look at the change in the participant's body weight from the start to the end
      of the study. This is to compare the effect on body weight in people taking semaglutide (a
      new medicine) and people taking "dummy" medicine. In addition to taking the study medicine,
      the participant will have talks with study staff about healthy food choices, how to be more
      physically active and what else the participant can do to lose weight. Overweight and obesity
      is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to
      have a beneficial impact on the blood sugar levels. The participant will either get
      semaglutide or "dummy" medicine - which treatment the participant get is decided by chance.
      The participant will need to take 2 injections at the same time once a week. The study
      medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.
      The study will last for about 1.5 years
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age greater than or equal to 18 years at the time of signing informed
             consent

          -  Body Mass Index (BMI) greater than or equal to 27 kg/m^2 '

          -  History of at least one self-reported unsuccessful dietary effort to lose body weight

          -  Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both
             inclusive)) 180 days or longer prior to the day of screening

        Exclusion Criteria:

          -  A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before
             screening irrespective of medical records

          -  Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less
             than 30 mL/min/1.73 m^2 (less than 60 ml/min/1.73 m^2 in subjects treated with
             Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease
             (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney
             Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening

          -  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 (e.g. optometrist) within the past 90
             days prior to screening or in the period between screening and randomisation