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

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)