Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT04022993
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 \< 9,0 g/dl; Hematocrit value \< 30 %; ALT and AST 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04022993
Study Brief:
Protocol Section:
NCT04022993