Clinical trial NCT04079413: Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients
Official title: An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40071 (OOO "GEROPHARM", Russia) Compared to NovoRapid® Penfill® (Novo Nordisk A/S, Denmark) in Type 1 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Keywords: Insulin
Insulin aspart
Aspart
Lead sponsor: Geropharm
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Immunogenicity
timeFrame: 26 weeks
Secondary outcomes:
measure: Glycated hemoglobin
timeFrame: 26 weeks
measure: Adverse Events frequency and degree
timeFrame: 26 weeks
measure: Fasting Plasma Glucose Level
timeFrame: 26 weeks
measure: Seven-Point Glucose Testing
timeFrame: 26 weeks
measure: Total Insulin Dose
timeFrame: 26 weeks
measure: Body Mass Index
timeFrame: 26 weeks
measure: Treatment Satisfaction
timeFrame: 26 weeks
measure: Achievement of Glycated Hemoglobin Goals
timeFrame: 26 weeks
measure: Achievement of Glycated Hemoglobin < 7%
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Arkhangel'sk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Hospital
city: Kazan
country: Russian Federation
facility: Kazan Endocrinology Dispensary
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky
city: Moscow
country: Russian Federation
facility: Endocrinology Research Centre (Moscow)
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint Petersburg
country: Russian Federation
facility: Polyclinic Сomplex
city: Saint Petersburg
country: Russian Federation
facility: City Diagnostic Center № 1
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic № 117
city: Saint Petersburg
country: Russian Federation
facility: EosMed
city: Saint Petersburg
country: Russian Federation
facility: Institute of Medical Research
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
city: Saint Petersburg
country: Russian Federation
facility: Pokrovskaya Municipal Hospital
city: Samara
country: Russian Federation
facility: Diabetes Center
city: Saratov
country: Russian Federation
facility: Clinical City Hospital № 9
Study officials:
References:
citation: Karonova TL, Mayorov AY, Magruk MA, Zyangirova ST, Grigoryeva IV, Khmelnitski OK, Myshkovets A, Parfenova TM, Mosikian AA, Drai RV. Safety and efficacy of GP40071 compared with originator insulin aspart (NovoRapid(R) Penfill(R)) in Type 1 diabetes mellitus. J Comp Eff Res. 2021 Jun;10(9):763-775. doi: 10.2217/cer-2020-0208. Epub 2021 Apr 30.