| Outcome Measures: |
Primary: Immunogenicity, Change from baseline in titer of antibodies to human insulin, 26 weeks | Secondary: Glycated hemoglobin, Change in HbA1c from baseline, 26 weeks|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|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, 22 weeks|Total Insulin Dose, Change in total insulin dose per body weight (U/kg) from baseline, 22 weeks|Body Mass Index, Change in BMI from baseline, 26 weeks|Treatment Satisfaction: The Diabetes Treatment Satisfaction Questionnaire, Change in treatment satisfaction from baseline. 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. DTSQ is The Diabetes Treatment Satisfaction Questionnaire, scored from 0-36 points with higher scores indicating better satisfaction., 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
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| 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|V.A. Baranov Republic Hospital, Petrozavodsk, 185000, 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|Institute of Medical Research, Saint Petersburg, 196084, Russian Federation|Research Center Eco-Safety, Saint Petersburg, 196143, Russian Federation|Almazov National Medical Research Centre, Saint Petersburg, 197341, Russian Federation|Pokrovskaya Municipal Hospital, Saint Petersburg, 199106, Russian Federation|Diabetes Center, Samara, 443067, Russian Federation|Volgograd Region Clinical Hospital №1, Volgograd, 400081, Russian Federation
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