Efficacy and Safety of GP40081 Сompared to NovoMix® 30 FlexPen® in Type 2 Diabetes Mellitus Patients

Geropharm

Status and phase

Unknown

Phase 3

Conditions

Diabetes Mellitus

Diabetes Mellitus, Type 2

Treatments

Drug: GP40081

Drug: NovoMix 30

Study type

Interventional

Funder types

Industry

Identifiers

NCT04226105

GP40081-P4-31

Details and patient eligibility

About

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®.

Enrollment

264 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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