Efficacy and Safety of GP40081 Сompared to NovoMix® 30 FlexPen® 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®.


Eligibility Criteria:
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