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

An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40071 (OOO "GEROPHARM", Russia) Compared to NovoRapid® Penfill® (Novo Nordisk A/S, Denmark) in Type 1 Diabetes Mellitus Patients

This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T1DM comparing the efficacy and safety of GP40071 (insulin aspart, GEROPHARM) with that of NovoRapid®.

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