Diabetes Mellitus, Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes Mellitus, Type 1, Insulin, Glargine
Brief summary
The study is designed to approve non-inferior efficacy and safety of Insulin RinGlar® compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients.
Interventions
DRUGLantus Solostar, 100 Units/mL Subcutaneous Solution
4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses
DRUGInsulin RinGlar, 100 Units/mL Subcutaneous Solution
4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses
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 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 6.5 to 12.0 % at screening (both values inclusive) * Body mass index (BMI) of 18.0 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 glargine * Insulin resistance over 1.5 U/kg insulin pro day * History of treatment any biosimilar insulin * History of treatment any experimental drugs or medical devices for 3 months prior to screening * History of treatment insulin pump for 90 days prior to signed written consent or indication for use insulin pump * Presence of severe diabetes complications * History of severe hypoglycemia during 6 months prior to signed written consent * History of 15 or more episodes mild hypoglycemia during 1 month prior to signed written consent * History or presence of uncontrolled diabetes mellitus for 6 months prior to screening * History of administration of glucocorticoids for 1 year prior to screening * Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum, etc.) * History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except adrenal insufficiency * 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 allergic 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 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 drug, alcohol abuse for 3 years prior to screening * Inability follow to protocol * History of oncological disease during 5 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response | 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 |
| Fasting Plasma Glucose Level | 26 weeks | Change in fasting plasma glucose level from baseline |
| Seven-Point Glucose Testing | 26 weeks | Change in seven-point glucose testing results from baseline |
| Basal Insulin Dose | 26 weeks | Change in basal insulin dose per body weight (U/kg) from baseline |
| Adverse Events frequency and degree | 26 weeks (4+22 weeks) | Hypoglycemic episodes (glucose level \< 3.9 mmol/l) frequency; Occurrence of local reactions at injection sites; Occurrence allergic reactions. |
| Body Mass Index | 26 weeks | Change in BMI from baseline |
| Treatment Satisfaction | 26 weeks | Change in overall treatment satisfaction (DTSQ score) from baseline |
| 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) |
| Total Insulin Dose | 26 weeks | Change in total insulin dose per body weight (U/kg) from baseline |
Countries
Russia
Outcome results
None listed