efficacy and safety of gp40071 compared to novorapid® penfill® in type 1 diabetes mellitus patients

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: 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®.


Eligibility criteria:
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 \ 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

Keywords: insulin insulin aspart aspart