Efficacy and Safety of Insulin Rinsulin® NPH Compared to Humulin® NPH in Type 2 Diabetes Mellitus Patients

Inclusion Criteria: * Signed written consent * Diabetes mellitus type 2 * Indications for Rinsulin NPH / Humalog NPH treatment * Glycosylated hemoglobin (HbA1c) level of 6.5 to 12.0 % at screening (both values inclusive) * Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive). * Female patients of childbearing potential who are willing to use two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the trial, through trial completion. Exclusion Criteria: * Age less than 18 years old at screening * Pregnant and breast-feeding women * Need of administration of glucocorticoid therapy or any other therapy that may influence glucose level * Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum) * Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or antibodies to Treponema pallidum (syphilis) at screening. * History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions. * History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.). * History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study * Presence of severe diabetes complications * Receipt of another investigational drug in the 3 months prior to screening * Acute psychiatric disorder or exacerbation of chronic psychiatric disorder at screening * History or presence of drug abuse * Positive test for addictive substance in urine at screening