Status:
COMPLETED
Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients
Lead Sponsor:
Geropharm
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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
- 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
- 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
Key Trial Info
Start Date :
June 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2020
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT04079413
Start Date
June 3 2019
End Date
January 21 2020
Last Update
July 23 2020
Active Locations (14)
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1
Arkhangelsk Regional Clinical Hospital
Arkhangelsk, Russia, 163045
2
Kazan Endocrinology Dispensary
Kazan', Russia, 420073
3
Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky
Krasnoyarsk, Russia, 660022
4
Endocrinology Research Centre (Moscow)
Moscow, Russia, 117036