Diabetes, Diabetes Mellitus, Type 1
Conditions
Keywords
Insulin, Insulin aspart, Aspart
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®.
Interventions
DRUGGP40071
GP40071, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake.
NovoRapid® Penfill®, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake.
Sponsors
Geropharm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
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 |
|---|---|---|
| Total Insulin Dose | 26 weeks | Change in total insulin dose per body weight (U/kg) from baseline |
| Body Mass Index | 26 weeks | Change in BMI from baseline |
| 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 |
| Seven-Point Glucose Testing | 26 weeks | Change in seven-point glucose testing results from baseline |
| Treatment Satisfaction | 26 weeks | Change in treatment satisfaction from baseline. The total score DTSQ (The Diabetes Treatment Satisfaction Questionnaire) (range 0-36). 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. |
| Achievement of Glycated Hemoglobin Goals | 26 weeks | The frequency of achievement glycated hemoglobin goals |
| Achievement of Glycated Hemoglobin < 7% | 26 weeks | The frequency of achievement glycated hemoglobin \< 7% ( 7% inclusive) |
| Fasting Plasma Glucose Level | 26 weeks | Change in fasting plasma glucose level from baseline |
Countries
Russia
Outcome results
None listed