Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients

Inclusion Criteria: * Signed written consent * Diabetes mellitus type 1 for at least 12 months prior to screening * History of basis-bolus (multiple dose injection (MDI)) therapy in stable doses at least 30 days * Glycated hemoglobin (HbA1c) level of 7.1 to 12.0 % at screening (both values inclusive) * Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive) * Subject is able and willing to comply with the requirements of the study protocol Exclusion Criteria: * Contraindication to the use of insulin aspart * Insulin resistance over 1.5 U/kg insulin pro day * Change INN of insulin for 6 months prior to randomisation * History of treatment any biosimilar insulin for 6 months prior to randomisation (excl. GEROPHARM's insulins) * History of treatment any experimental drugs or medical devices for 3 months prior to randomisation * History of treatment insulin pump for 180 days prior to signed written consent or indication for use insulin pump * Presence of severe diabetes complications * History of severe hypoglycemia for 6 months prior to screening * History of 15 or more episodes mild hypoglycemia for 1 month prior to screening * History or presence of uncontrolled diabetes mellitus for 6 months prior to screening * History of administration of glucocorticoids (14 days or more) for 1 year prior to screening * Administration of any immunosuppressive drugs (Cyclosporine, Methotrexate, Rituximab, etc.) * History of vaccination for 6 months prior to randomisation * History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except adrenal insufficiency * History of unstable angina, myocardial infarction, severe arrhythmia, heart failure III or IV NYHA for 1 year prior to screening * History of stroke or TIA for 6 months prior to 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 * Pregnant and breast-feeding women * 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.) * Incomplete recovery after surgery procedure * History of drug, alcohol abuse for 3 years prior to screening * Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or syphilis (Treponema pallidum) antibodies at screening * History of oncological disease during 5 years prior to screening * History of transplantation, except 3 months after corneal transplant * History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study * Inability follow to protocol