Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients

Inclusion Criteria: * Signed written consent * Clinical diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening * Glycosylated hemoglobin (HbA1c) level of 7.6 to 12.0 % at screening (both values inclusive) * Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive) * Stable doses OADs for at least 3 months prior to treatment of experimental drug * 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: * Acute inflammation disease for 3 weeks prior to screening * Deviation of the laboratory results conducted during the screening: Hemoglobin value \< 9,0 g/dl; Hematocrit value \< 30 %; ALT and AST value \> 2 folds as high as maximal normal value; Serum bilirubin value \> 1.5 folds as high as maximal normal value * History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.) * Serious blood loss for 3 months prior to screening (blood donation, surgery procedure, etc.) * Contraindication to the use of insulin Lispro Biphasic 25 * Insulin resistance over 1.5 U/kg insulin pro day * Presence of insulin antibodies in the blood at the screening ˃10 U/ml * Use of 3 or more oral antidiabetic drugs (OAD) * Presence of severe diabetes complications * History or presence of uncontrolled diabetes mellitus for 6 months prior to screening * Deviation of vital signs, which can influence to results * History of administration of glucocorticoids for 1 year prior to screening * History of autoimmune disease, except controlled autoimmune thyroid disease * Pregnant and breast-feeding women * 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 * Administration of any immunosuppressive drugs (Cyclosporinum, Methotrexatum) * Incomplete recovery after surgery procedure