efficacy and safety of insulin ringlar® compared to lantus® solostar® in type 1 diabetes mellitus patients

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus

Summary: the study is designed to approve non-inferior efficacy and safety of insulin ringlar® compared to lantus® solostar® in type 1 diabetes mellitus patients.


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 6.5 to 12.0 % at screening (both values inclusive) * body mass index (bmi) of 18.0 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 glargine * insulin resistance over 1.5 u/kg insulin pro day * history of treatment any biosimilar insulin * history of treatment any experimental drugs or medical devices for 3 months prior to screening * history of treatment insulin pump for 90 days prior to signed written consent or indication for use insulin pump * presence of severe diabetes complications * history of severe hypoglycemia during 6 months prior to signed written consent * history of 15 or more episodes mild hypoglycemia during 1 month prior to signed written consent * history or presence of uncontrolled diabetes mellitus for 6 months prior to screening * history of administration of glucocorticoids for 1 year prior to screening * administration of any immunosupressive drugs (cyclosporinum, methotrexatum, etc.) * history of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (aps) types 1-3, except adrenal insufficiency * 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 allergic 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 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 drug, alcohol abuse for 3 years prior to screening * inability follow to protocol * history of oncological disease during 5 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 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

Keywords: diabetes mellitus, type 1 insulin glargine