efficacy and safety of gp40081 сompared to novomix® 30 flexpen® in type 2 diabetes mellitus patients

Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus

Summary: 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 \ 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