200
Participants
Start Date
May 7, 2013
Primary Completion Date
July 31, 2016
Study Completion Date
July 10, 2016
Subetta
"Each Subetta tablet contains a mixture of affinity purified polyclonal antibodies to β-subunit of the rINS (6 mg) and antibodies to eNOS (6 mg) in released-active form produced by the patented technology in accordance with the applicable European Pharmacopeia requirements.~Standard therapy of type I diabetes mellitus + Subetta (1 tablet 4 times a day) for 36 weeks.~Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime)."
Placebo
"Placebo (identical to Subetta in shape and taste tablet containing exсipients). Standard therapy of type I diabetes mellitus + Placebo (1 tablet 4 times a day) for 36 weeks.~Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime)."
"State Healthcare Institution of Moscow Central research institute of gastroenterology of Department of health care of Moscow", Moscow
"State Educational Institution of Higher Professional Education Moscow State Medical Academy named after I.M. Sechenov", Moscow
"Nonstate Health Care Institution Central Clinical Hospital №2 named after N.A. Semashko of Public Limited Company Russian Railways", Moscow
"Municipal budgetary authority Khimki Central Clinical Hospital", Moscow Region
"State Budgetary Health Care Institution of Yaroslavl Region Regional Сlinical Hospital", Yaroslavl
"Private company Polyclinic Complex", Saint Petersburg
"St. Petersburg State Budgetary Health Care Institution City Polyclinic №6", Saint Petersburg
"St. Petersburg State Budgetary Health Care Institution Saint Venerable Martyr Elizaveta Municipal Hospital", Saint Petersburg
"State Budgetary Educational Institution of High Professional Training St. Petersburg State Medical University named after academician I.P. Pavlov of Ministry of Health of Russian Federation, Therapy Faculty Board", Saint Petersburg
"St. Petersburg Sate Budgetary Institution Consultative-Diagnostic Polyclinic №1 of Coastal Area", Saint Petersburg
"State Budgetary Educational Institution of High Professional Training Rostov State Medical University of Ministry of Health of Russian Federation, Department of Endocrinology", Rostov-on-Don
"Independent Health Care Institution of Voronezh Region Voronezh Regional Clinical Consultative-Diagnostic Center", Voronezh
"Co.Ltd Diabet Center", Samara
"The State Budgetary Institution of Health Care of the Nizhny Novgorod Region City clinical hospital No. 10 ", Nizhny Novgorod
"Nizhny Novgorod regional State Budgetary Health Institution Nizhny Novgorod regional Clinical Hospital named after N.A. Semashko ", Nizhny Novgorod
Lead Sponsor
Materia Medica Holding
INDUSTRY