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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT04226105
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04226105
Study Brief:
Protocol Section:
NCT04226105