INS and type 2 diabetes mellitus: since 09/01/2013 in type 2 diabetes patients treated with NPH insulin for at least 6 months and with HbA1c ≥8%, in type 2 diabetes patients treated with NPH insulin for at least 6 months and with documented recurring episodes of severe or nocturnal hypoglycaemia, and in diabetes with a known cause (in accordance with the WHO definition)