Diabetes Mellitus, Type 2, Diabetes Mellitus
Conditions
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®.
Interventions
DRUGGP40081
1 ml of the GP40081 contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70. Insulin aspart 30 mix is self-administered drug by SC injection 1-3 times per day before meal intake.
DRUGNovoMix 30
1 ml of the NovoMix 30 contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70. Insulin aspart 30 mix is self-administered drug by SC injection 1-3 times per day before meal intake.
Sponsors
Geropharm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | 26 weeks | Change from baseline in titer of antibodies to human insulin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycated hemoglobin | 26 weeks | Change in HbA1c from baseline |
| Adverse Events frequency and degree | 26 weeks | Hypoglycemic episodes (glucose level \< 3.9 mmol/l) frequency; Occurrence of local reactions at injection sites; Occurrence allergic reactions |
| Fasting Plasma Glucose Level | 26 weeks | Change in fasting plasma glucose level from baseline |
| Seven-Point Glucose Testing | 22 weeks | Change in seven-point glucose testing results from baseline |
| Achievement of Glycated Hemoglobin < 7% | 26 weeks | The frequency of achievement glycated hemoglobin \< 7% ( 7% inclusive) |
| Body Mass Index | 26 weeks | Change in BMI from baseline |
| Treatment Satisfaction: The Diabetes Treatment Satisfaction Questionnaire | 26 weeks | Change in treatment satisfaction from baseline. Questions 1, 4, 5, 6, 7 and 8 assesses treatment satisfaction (summed these 6 questions). Questions 2 and 3 assess the burden from hyper- and hypoglycemia. DTSQ is The Diabetes Treatment Satisfaction Questionnaire, scored from 0-36 points with higher scores indicating better satisfaction. |
| Achievement of Glycated Hemoglobin Goals | 26 weeks | The frequency of achievement glycated hemoglobin goals |
| Total Insulin Dose | 22 weeks | Change in total insulin dose per body weight (U/kg) from baseline |
Countries
Russia
Outcome results
None listed