Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Faster-acting insulin aspart; Insulin aspart; Insulin degludec; Metformin
Intervention description: Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.; Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.; Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.; Only participants who took metformin before the study should take metformin tablets, same dose as before the study
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Enrollment: 1264.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new
      medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting
      insulin aspart will be tested to see how well it works and if it is safe. Participants will
      get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is
      decided by chance. Both medicines will be taken together with insulin degludec. Participants
      will need to take 1 injection 4 times every day (all insulins will be provided in pens). The
      study will last for about 8 months (34 weeks).
    

Eligibility criteria:

        Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing
        informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to
        screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer
        prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal
        insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times
        daily. Treatment with premixed insulin or soluble insulin combination is not considered a
        basal-bolus regimen. - Treated with or without oral antidiabetic drugs including extended
        release formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory
        at screening (Visit 1). Exclusion Criteria: - 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 (Visit 1). - 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 (Visit 1). - Treatment with
        injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). -
        Anticipated initiation or change in concomitant medications (for more than 14 consecutive
        days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid
        hormones, or corticosteroids).