Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients
- Conditions
- Diabetes Mellitus, Type 1Diabetes Mellitus
- Interventions
- Drug: Insulin RinGlar, 100 Units/mL Subcutaneous Solution
- Registration Number
- NCT04022993
- Lead Sponsor
- Geropharm
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lantus® SoloStar® Lantus Solostar, 100 Units/mL Subcutaneous Solution Lantus® SoloStar® once a day, individually glucose-level based administered in stable doses, started before enrollement Insulin RinGlar® Insulin RinGlar, 100 Units/mL Subcutaneous Solution Insulin RinGlar® once a day, individually glucose-level based administered in stable doses, started before enrollement
- Primary Outcome Measures
Name Time Method Antibody Response 26 weeks Change from baseline in titer of antibodies to human insulin
- Secondary Outcome Measures
Name Time Method Total Insulin Dose 26 weeks Change in total insulin dose per body weight (U/kg) 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)
Basal Insulin Dose 26 weeks Change in basal insulin dose per body weight (U/kg) 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
Body Mass Index 26 weeks Change in BMI 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.
Glycated hemoglobin 26 weeks Change in HbA1c from baseline
Treatment Satisfaction 26 weeks Change in overall treatment satisfaction (DTSQ score) from baseline
Trial Locations
- Locations (14)
Clinical City Hospital № 9
🇷🇺Saratov, Russian Federation
City Diagnostic Center № 1
🇷🇺Saint Petersburg, Russian Federation
City Hospital № 2
🇷🇺Saint Petersburg, Russian Federation
EosMed
🇷🇺Saint Petersburg, Russian Federation
Endocrinology Research Centre (Moscow)
🇷🇺Moscow, Russian Federation
Almazov National Medical Research Centre
🇷🇺Saint Petersburg, Russian Federation
Kazan Endocrinology Dispensary
🇷🇺Kazan, Russian Federation
V.A. Baranov Republic Hospital
🇷🇺Petrozavodsk, Russian Federation
City Polyclinic № 117
🇷🇺Saint Petersburg, Russian Federation
Rostov State Medical University
🇷🇺Rostov-on-Don, Russian Federation
Polyclinic Сomplex
🇷🇺Saint Petersburg, Russian Federation
Arkhangelsk Regional Clinical Hospital
🇷🇺Arkhangel'sk, Russian Federation
Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky
🇷🇺Krasnoyarsk, Russian Federation
Pokrovskaya Municipal Hospital
🇷🇺Saint Petersburg, Russian Federation