Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients

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 \< 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 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