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Clinical Trial Details

Trial ID: L6980
Source ID: NCT04022993
Associated Drug: Lantus Solostar, 100 Units/Ml Subcutaneous Solution
Title: Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1|Diabetes Mellitus
Interventions: DRUG: Lantus Solostar, 100 Units/mL Subcutaneous Solution|DRUG: Insulin RinGlar, 100 Units/mL Subcutaneous Solution
Outcome Measures: Primary: Antibody Response, Change from baseline in titer of antibodies to human insulin, 26 weeks | Secondary: 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
Sponsor/Collaborators: Sponsor: Geropharm
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 180
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-07-04
Completion Date: 2019-05-15
Results First Posted:
Last Update Posted: 2019-07-17
Locations: Arkhangelsk Regional Clinical Hospital, Arkhangel'sk, 163045, Russian Federation|Kazan Endocrinology Dispensary, Kazan, 420073, Russian Federation|Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky, Krasnoyarsk, 660022, Russian Federation|Endocrinology Research Centre (Moscow), Moscow, 117036, Russian Federation|V.A. Baranov Republic Hospital, Petrozavodsk, 185000, Russian Federation|Rostov State Medical University, Rostov-on-Don, 344022, Russian Federation|Polyclinic Сomplex, Saint Petersburg, 190013, Russian Federation|City Diagnostic Center № 1, Saint Petersburg, 194354, Russian Federation|City Hospital № 2, Saint Petersburg, 194354, Russian Federation|City Polyclinic № 117, Saint Petersburg, 194358, Russian Federation|EosMed, Saint Petersburg, 195197, Russian Federation|Almazov National Medical Research Centre, Saint Petersburg, 197341, Russian Federation|Pokrovskaya Municipal Hospital, Saint Petersburg, 199106, Russian Federation|Clinical City Hospital № 9, Saratov, 410030, Russian Federation
URL: https://clinicaltrials.gov/show/NCT04022993

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress