Clinical trial NCT04226105: Efficacy and Safety of GP40081 Сompared to NovoMix® 30 FlexPen® in Type 2 Diabetes Mellitus Patients
Official title: An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40081 (OOO "GEROPHARM", Russia) Compared to NovoMix® 30 FlexPen® (Novo Nordisk A/S, Denmark) in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus
Lead sponsor: Geropharm
Sponsor class: INDUSTRY
First posted: 2020-01-13
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
Primary purpose: TREATMENT

Brief summary: This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T2DM comparing the efficacy and safety of GP40081 (insulin asapart mix 30, GEROPHARM) with that of NovoMix® 30 FlexPen®.


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

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: 22 weeks
measure: Total Insulin Dose
timeFrame: 22 weeks
measure: Body Mass Index
timeFrame: 26 weeks
measure: Treatment Satisfaction: The Diabetes Treatment Satisfaction Questionnaire
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: Petrozavodsk
country: Russian Federation
facility: V.A. Baranov Republic Hospital
city: Saint Petersburg
country: Russian Federation
facility: City Diagnostic Center № 1
city: Saint Petersburg
country: Russian Federation
facility: City Hospital № 2
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: Research Center Eco-Safety
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: Volgograd
country: Russian Federation
facility: Volgograd Region Clinical Hospital №1
Study officials:
References: