Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes

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