Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Faster-acting insulin aspart; basal insulin
Intervention description: Administrated subcutaneously (s.c., under the skin) at each main meal.; Administrated subcutaneously (s.c., under the skin) once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe, South America, and the United States of America
      (USA).

      The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen
      versus basal insulin therapy, both in combination with metformin in adult subjects with type
      2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening
             visit (Visit 1)

          -  Current treatment with once daily insulin detemir, insulin glargine or human isophane
             insulin, NPH 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 Dipeptidyl peptidase-IV 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) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the
             metformin group at the screening visit (Visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol)
             (both inclusive) in the metformin + other oral antidiabetic drug (OAD) (sulphonylurea
             (SU), glinide, dipeptidyl peptidase-IV (DDP-IV) inhibitors, alpha-glucosidase
             inhibitors (AGI) combination group at the screening visit (Visit 1)

          -  Body mass index (BMI) equal or less than 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 of consecutive treatment) and not within 3 months prior to the screening
             visit (Visit 1)

          -  Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) within
             the last 3 months prior to screening (visit 1)

          -  Recurrent severe hypoglycaemia (more than one 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)