Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults 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 glargine
Intervention description: Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.; Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted.; Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; 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: Double (Participant, Investigator)
Enrollment: 881.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare
      FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin
      glargine and metformin in adults with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria: - Type 2 diabetes (diagnosed clinically) for 6 months or longer at time
        of screening (visit 1) - Treated with basal insulin for at least 6 months prior to
        screening (visit 1) - Current once daily treatment with insulin NPH (Neutral Protamine
        Hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit
        (visit 1) - Current treatment with: a. metformin with unchanged dosing for at least 3
        months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b.
        metformin in combination with sulfonylurea (SU) or glinide or DPP-IV (dipeptidyl
        peptidase-4) inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for
        at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
        - HbA1c by central laboratory: a. 7.0 - 9.5% (53 - 80 mmol/mol) (both inclusive) in the
        metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 - 75 mmol/mol) (both
        inclusive) in the metformin + other OAD (oral antidiabetic drug) (SU, glinide, DDP-IV
        inhibitors, AGI) combination group at the screening visit (visit 1) - Body mass index (BMI)
        equal to or below 40.0 kg/m^2 Exclusion Criteria: - Any use of bolus insulin, except
        short-term use due to intermittent illness (no longer than 14 days consecutive treatment)
        and not 3 months prior to the screening visit (visit 1) - Use of GLP-1 (glucagon-like
        peptide-1) agonists and/or TZDs within the last 3 months prior to screening (visit 1) -
        Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12
        months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for
        diabetic ketoacidosis during the previous 6 months prior to screening (visit 1) -
        Cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as:
        stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV,
        myocardial infarction, unstable angina pectoris or coronary arterial bypass graft or
        angioplasty