Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients

Study Overview
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Brief Summary
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The study is designed to approve non-inferior efficacy and safety of Insulin RinGlar® compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients.

Official Title
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An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Insulin RinGlar® (Geropharm, Russia) Compared to Lantus® SoloStar® (Sanofi-Aventis Deutschland GmbH, Germany) in Type 1 Diabetes Mellitus Patients

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus

Intervention / Treatment
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* Drug: Lantus Solostar, 100 Units/mL Subcutaneous Solution
* Drug: Insulin RinGlar, 100 Units/mL Subcutaneous Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lantus® SoloStar®<br>Lantus® SoloStar® once a day, individually glucose-level based administered in stable doses, started before enrollement | Drug: Lantus Solostar, 100 Units/mL Subcutaneous Solution<br>* 4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses<br>|
| Experimental: Insulin RinGlar®<br>Insulin RinGlar® once a day, individually glucose-level based administered in stable doses, started before enrollement | Drug: Insulin RinGlar, 100 Units/mL Subcutaneous Solution<br>* 4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody Response | Change from baseline in titer of antibodies to human insulin | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events frequency and degree | Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency; Occurrence of local reactions at injection sites; Occurrence allergic reactions. | 26 weeks (4+22 weeks) | 
| Glycated hemoglobin | Change in HbA1c from baseline | 26 weeks | 
| Fasting Plasma Glucose Level | Change in fasting plasma glucose level from baseline | 26 weeks | 
| Seven-Point Glucose Testing | Change in seven-point glucose testing results from baseline | 26 weeks | 
| Basal Insulin Dose | Change in basal insulin dose per body weight (U/kg) from baseline | 26 weeks | 
| Total Insulin Dose | Change in total insulin dose per body weight (U/kg) from baseline | 26 weeks | 
| Body Mass Index | Change in BMI from baseline | 26 weeks | 
| Treatment Satisfaction | Change in overall treatment satisfaction (DTSQ score) from baseline | 26 weeks | 
| Achievement of Glycated Hemoglobin Goals | The frequency of achievement glycated hemoglobin goals | 26 weeks | 
| Achievement of Glycated Hemoglobin < 7% | The frequency of achievement glycated hemoglobin < 7% ( 7% inclusive) | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 1, Insulin, Glargine