Efficacy and Safety of GP40081 Сompared to NovoMix® 30 FlexPen® in Type 2 Diabetes Mellitus Patients

An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40081 (OOO "GEROPHARM", Russia) Compared to NovoMix® 30 FlexPen® (Novo Nordisk A/S, Denmark) in Type 2 Diabetes Mellitus Patients

This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T2DM comparing the efficacy and safety of GP40081 (insulin asapart mix 30, GEROPHARM) with that of NovoMix® 30 FlexPen®.

Inclusion Criteria:

• Signed written consent
• Diabetes mellitus type 2 for at least 6 months before the screening (WHO criteria 1999-2013).
• Glycated haemoglobin (HbA1c) level of 7.6 to 12.0 % at screening (both values inclusive).
• Indications for exogenous insulin therapy.
• Body mass index (BMI) of 18.5 to 40 kg/m2 at screening (both values inclusive).
• Insulin-naive patients or prior insulin therapy at least 6 months before randomization.
• The subject is able and willing to comply with the requirements of the study protocol

Exclusion Criteria:

• Contraindication to the use of insulin aspart 30 mix.
• 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 severe hypoglycemia for 6 months before the screening.
• History of severe hyperglycemia for 6 months before the screening.
• Bariatric surgery for 12 months to screening.
• Glucagon-like peptide-1 (GLP-1)-based therapies for 8 weeks to screening.
• Insulin resistance over 1.5 U/kg insulin pro day.
• Change INN of insulin for 6 months before the randomisation.
• History of treatment any experimental drugs or medical devices for 3 months before the randomisation.
• Presence of severe diabetes complications.
• Night work.
• History of administration of glucocorticoids (14 days or more) for 1 year before the screening.
• Administration of any immunosuppressive drugs (Cyclosporinum, Methotrexate, Rituximab, etc.).
• History of vaccination for 6 months before the randomisation.
• History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except vetiligo and Hashimoto's thyroiditis.
• Pregnant and breast-feeding women.
• Deviation of the laboratory results conducted during the screening: Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds or ALT or AST value > 3 folds as high as maximal normal value; Serum bilirubin value > 2 folds as high as maximal normal value (except Gilbert's syndrome).
• History of haematological disorders that can affect the reliability of HbA1c estimation (haemoglobinopathies, hemolytic anaemia, etc.).
• Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or syphilis (Treponema pallidum) antibodies at the screening.
• Acute inflammation disease for 3 weeks before the screening.
• History of unstable angina, myocardial infarction, severe arrhythmia, heart failure III or IV NYHA for 1 year before the screening.
• History of stroke or TIA for 6 months before the screening.
• Serious blood loss for 3 months before the screening (blood donation, surgery procedure, etc.).
• The inability of the patient to assess their condition because of mental or physical disorders.
• History of drug, alcohol abuse for 3 years before the screening.
• History of oncology disorders for 5 years before the screening.
• History of transplantation, except 3 months after a 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