[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100199141":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":144,"collaborators":26,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":26,"eligibilityCriteria":152,"healthyVolunteers":153,"sex":154,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":26,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":168,"whyStopped":26,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Materia Medica Holding","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Subetta group","EXPERIMENTAL","Patients with poor glycemic control (HbA1c=7.0-10.0%) in basal-bolus insulin regimen with a stable basal insulin dose (permissible fluctuations are ±10%) during the previous 3 months are included",[13],"Drug: Subetta",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Patients with poor glycemic control (HbA1c=7.0-10.0%) in basal-bolus insulin regimen with a stable basal insulin dose (permissible fluctuations are ±10%) during the previous 3 months are included.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","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.\n\nStandard therapy of type I diabetes mellitus + Subetta (1 tablet 4 times a day) for 36 weeks.\n\nSubetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.\n\nPlacebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).",[15],[32,44,50,56,60,69,75,84,93,99,105,111,117,126,135],{"facility":33,"status":26,"city":34,"state":26,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":26},"State Healthcare Institution of Moscow \"Central research institute of gastroenterology\" of Department of health care of Moscow","Moscow","111123","Russia","RU",{"type":39,"coordinates":40},"Point",[41,42],37.61781,55.75204,{"lat":42,"lon":41},{"facility":45,"status":26,"city":34,"state":26,"zip":46,"country":36,"countryCode":37,"cosmosGeoPoint":47,"geoPoint":49,"contacts":26},"State Educational Institution of Higher Professional Education \"Moscow State Medical Academy named after I.M. Sechenov\"","119991",{"type":39,"coordinates":48},[41,42],{"lat":42,"lon":41},{"facility":51,"status":26,"city":34,"state":26,"zip":52,"country":36,"countryCode":37,"cosmosGeoPoint":53,"geoPoint":55,"contacts":26},"Nonstate Health Care Institution \"Central Clinical Hospital №2 named after N.A. Semashko of Public Limited Company \"Russian Railways\"","129128",{"type":39,"coordinates":54},[41,42],{"lat":42,"lon":41},{"facility":57,"status":26,"city":58,"state":26,"zip":59,"country":36,"countryCode":37,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Municipal budgetary authority \"Khimki Central Clinical Hospital\"","Moscow Region","141400",{"facility":61,"status":26,"city":62,"state":26,"zip":63,"country":36,"countryCode":37,"cosmosGeoPoint":64,"geoPoint":68,"contacts":26},"The State Budgetary Institution of Health Care of the Nizhny Novgorod Region \"City clinical hospital No. 10 \"","Nizhny Novgorod","603011",{"type":39,"coordinates":65},[66,67],44.00205,56.32867,{"lat":67,"lon":66},{"facility":70,"status":26,"city":62,"state":26,"zip":71,"country":36,"countryCode":37,"cosmosGeoPoint":72,"geoPoint":74,"contacts":26},"Nizhny Novgorod regional State Budgetary Health Institution \" Nizhny Novgorod regional Clinical Hospital named after N.A. Semashko \"","603126",{"type":39,"coordinates":73},[66,67],{"lat":67,"lon":66},{"facility":76,"status":26,"city":77,"state":26,"zip":78,"country":36,"countryCode":37,"cosmosGeoPoint":79,"geoPoint":83,"contacts":26},"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","344022",{"type":39,"coordinates":80},[81,82],39.70769,47.21997,{"lat":82,"lon":81},{"facility":85,"status":26,"city":86,"state":26,"zip":87,"country":36,"countryCode":37,"cosmosGeoPoint":88,"geoPoint":92,"contacts":26},"Private company \"Polyclinic Complex\"","Saint Petersburg","190013",{"type":39,"coordinates":89},[90,91],30.31413,59.93863,{"lat":91,"lon":90},{"facility":94,"status":26,"city":86,"state":26,"zip":95,"country":36,"countryCode":37,"cosmosGeoPoint":96,"geoPoint":98,"contacts":26},"St. Petersburg State Budgetary Health Care Institution \"City Polyclinic №6\"","191482",{"type":39,"coordinates":97},[90,91],{"lat":91,"lon":90},{"facility":100,"status":26,"city":86,"state":26,"zip":101,"country":36,"countryCode":37,"cosmosGeoPoint":102,"geoPoint":104,"contacts":26},"St. Petersburg State Budgetary Health Care Institution \"Saint Venerable Martyr Elizaveta Municipal Hospital\"","195257",{"type":39,"coordinates":103},[90,91],{"lat":91,"lon":90},{"facility":106,"status":26,"city":86,"state":26,"zip":107,"country":36,"countryCode":37,"cosmosGeoPoint":108,"geoPoint":110,"contacts":26},"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","197022",{"type":39,"coordinates":109},[90,91],{"lat":91,"lon":90},{"facility":112,"status":26,"city":86,"state":26,"zip":113,"country":36,"countryCode":37,"cosmosGeoPoint":114,"geoPoint":116,"contacts":26},"St. Petersburg Sate Budgetary Institution \"Consultative-Diagnostic Polyclinic №1 of Coastal Area\"","197183",{"type":39,"coordinates":115},[90,91],{"lat":91,"lon":90},{"facility":118,"status":26,"city":119,"state":26,"zip":120,"country":36,"countryCode":37,"cosmosGeoPoint":121,"geoPoint":125,"contacts":26},"Co.Ltd \" Diabet Center\"","Samara","443067",{"type":39,"coordinates":122},[123,124],50.13553,53.20767,{"lat":124,"lon":123},{"facility":127,"status":26,"city":128,"state":26,"zip":129,"country":36,"countryCode":37,"cosmosGeoPoint":130,"geoPoint":134,"contacts":26},"Independent Health Care Institution of Voronezh Region \"Voronezh Regional Clinical Consultative-Diagnostic Center\"","Voronezh","394018",{"type":39,"coordinates":131},[132,133],39.19204,51.66833,{"lat":133,"lon":132},{"facility":136,"status":26,"city":137,"state":26,"zip":138,"country":36,"countryCode":37,"cosmosGeoPoint":139,"geoPoint":143,"contacts":26},"State Budgetary Health Care Institution of Yaroslavl Region \"Regional Сlinical Hospital\"","Yaroslavl","150062",{"type":39,"coordinates":140},[141,142],39.87368,57.62987,{"lat":142,"lon":141},{"type":145,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100199141","phase-4-clinical-trial-of-efficacy-and-safety-of-subetta-in-the-combined-treatment-of-patients-with-type-i-diabetes-mellitus-100199141",true,"NCT01868594","Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus","Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus","Inclusion Criteria:\n\n1. Diagnosed type I diabetes mellitus (according to WHO criteria, 1999 - 2006).\n2. Disease duration no less than 6 months.\n3. Patient's age from 18 to 65 years inclusive.\n4. Level of glycosylated hemoglobin 7.0- 10.0 %.\n5. Glomerular filtration rate ≥ 60 ml\u002F min\u002F1.73m\\^2.\n6. Stable dose of basal insulin for the last 3 months. (Permissible fluctuations are ±10%.)\n7. Usage of contraceptive methods by both gender patients of reproductive age during the trial and within 30 days after ending the participation in the trial.\n8. Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.\n\nExclusion Criteria:\n\n1. Acute diabetes mellitus complications for 3 months prior to inclusion in the trial (diabetic ketoacidosis, hyperosmolar hyperglycemic state, lacticemia, severe hypoglycemia and hypoglycemic coma).\n2. Diabetic retinopathy, preproliferative, proliferative or terminal stages (based on the results of oculist examination during screening period or 6 months prior to the trial).\n3. Diabetic nephropathy, proteinuria stage, chronic kidney disease on 3, 4 or 5 stage.\n4. Diabetic microangiopathy:\n\n   * ishemic heart disease (medical history of a sudden coronary death with successful reanimation, medical history of myocardial infarction, stable exertional angina III or IV FC; unstable angina; post-infarction cardiosclerosis; chronic heart failure III or IV FC);\n   * cerebrovascular diseases (medical history of acute cerebrovascular accident; progressive vascular leukoencephalopathy; vascular dementia);\n   * chronic obliterative peripheral vascular diseases (clinically significant);\n   * diabetic neuroosteoarthropathy;\n   * diabetic foot (clinically significant).\n5. Heart rhythm disorder:\n\n   * II-III atrioventricular block;\n   * sick sinus syndrome;\n   * long QT interval syndrome;\n   * complete left bundle branch block;\n   * block of 2\u002F3 bundle branches;\n   * WPW syndrome;\n   * ventricular arrhythmia of III grade according Laun-Wolf;\n   * paroxysmal supraventricular tachycardia;\n   * paroxysmal\u002Frecurrent ventricular tachycardia;\n   * atrial flutter and fibrillation;\n   * ventricular flutter and fibrillation;\n   * heart pacemaker implant.\n6. Uncontrolled arterial hypertension characterized by the following blood tension values: systolic blood pressure over 160 mm Hg and\u002For diastolic blood pressure over 100 mm Hg.\n7. Severe concomitant pathology including clinically significant cardiovascular diseases of III - IV functional class (according to New York Heart Association classification, 1964), nervous and endocrine system diseases, including morbid obesity (body mass index≥40.0 kg\u002Fm2), renal insufficiency, liver failure.\n8. Medical history of pancreatectomy or transplantation of pancreatic\u002Fislet cells.\n9. Medical history of renal transplantation.\n10. Malignant neoplasms\u002Fsuspected malignant neoplasms.\n11. Exacerbations or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial.\n12. Level of fasting triglycerides \\>5.64 mmol\u002FL.\n13. Medical history of bariatric surgical operations.\n14. Medical history of polyvalent allergy.\n15. Allergy\u002F intolerance to any of the components of medications used in the treatment.\n16. Intake of medicines listed in the section \"Prohibited concomitant treatment\" for 3 months prior to the inclusion in the trial.\n17. Pregnancy, breast-feeding.\n18. Drug addiction, alcohol usage in the amount exceeding 2 units of alcohol per day.\n19. Mental disorders of a patient.\n20. Night work.\n21. Participation in other clinical trials in the course of 3 months prior to the inclusion in the trial.\n22. Patients, who from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.\n23. Other factors impeding patient's participation in the trial (for example, planned business trips or journeys).\n24. Patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the researcher. The immediate relative includes husband\u002Fwife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.\n25. Patient works for OOO \"NPF \"Materia Medica Holding\" (i.e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative.",false,"ALL","18 Years","65 Years",{"count":158,"type":159},200,"ACTUAL","INTERVENTIONAL",[162],"PHASE4","The purpose of this study is:\n\n* to assess clinical efficacy of Subetta in the combined treatment of type I diabetes mellitus;\n* to assess safety of Subetta in the combined treatment of type I diabetes mellitus.",[165],"Type I Diabetes Mellitus",[167],"Combined treatment of patients with type I diabetes mellitus","COMPLETED","2019-05-15",{"date":171,"type":159},"2019-05-30",{"date":173,"type":159},"2013-05-07",{"date":175,"type":159},"2016-07-10",{"name":5,"class":6},15]