Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT01868594
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2013-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608938', 'term': 'subetta'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PutilovskiyMA@materiamedica.ru', 'phone': '+74952761571', 'title': 'Michael Putilovskiy, MD, PhD, Clinical Research and Medical Information Director', 'phoneExt': '302', 'organization': 'Materia Medica Holding'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse/Serious adverse events were registered during 36 weeks of therapy and 30 days after the end of therapy.', 'description': 'Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=151, Safety Population)', 'eventGroups': [{'id': 'EG000', 'title': 'Subetta', 'description': 'Standard therapy of type I diabetes mellitus + Subetta (1 tablet 4 times a day).\n\nSubetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nSubetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus', 'otherNumAtRisk': 76, 'otherNumAffected': 16, 'seriousNumAtRisk': 76, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Standard therapy of type I diabetes mellitus + Placebo (1 tablet 4 times a day).\n\nPlacebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nPlacebo', 'otherNumAtRisk': 75, 'otherNumAffected': 18, 'seriousNumAtRisk': 75, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Inflammation of inguinal lymphonodus on the right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Goiter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subclinical hypothyreoidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacterial food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Heartburn', 'notes': 'exacerbation of chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dentalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increase in body temperature to 38.5 C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increase in body temperature up to 38.2 С', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic hepatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Allergic reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Parodontosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion of the hand', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increased blood pressure to 150/90 mm Hg, headache, nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increased body temperature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fasting hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in the shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Heavy legs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leg cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cervicalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vasomotor rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increased blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Hypertension arterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fracture of humerus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Parotid abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic venous insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicose veins of lower extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Type I diabetes mellitus with ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in the Mean Value of HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subetta', 'description': 'Short-acting and Long-acting human insulins + Subetta (1 tablet 4 times a day). Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nSubetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Short-acting and Long-acting human insulins + Placebo (1 tablet 4 times a day). Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nPlacebo'}], 'classes': [{'title': '12 weeks', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': '36 weeks', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\\*visit interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12, 24 and 36 weeks of the treatment', 'description': 'The HbA1C test was performed using a method that is certified by the National Glycohemoglobin Standardization Program (NGSP) (www.ngsp.org) and standardized or traceable to the Diabetes Control and Complications Trial (DCCT) reference assay.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat set'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (Based on the Data of Biochemical Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subetta', 'description': 'Short-acting and Long-acting human insulins + Subetta (1 tablet 4 times a day). Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nSubetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Short-acting and Long-acting human insulins + Placebo (1 tablet 4 times a day). Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nPlacebo'}], 'classes': [{'title': '4 weeks', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '4.9', 'groupId': 'OG001'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '5.4', 'groupId': 'OG001'}]}]}, {'title': '36 weeks', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0432', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with "treatment" factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\\*visit interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4, 12, 24 and 36 weeks of the treatment', 'unitOfMeasure': 'mmol / l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat set'}, {'type': 'SECONDARY', 'title': 'Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subetta', 'description': 'Short-acting and Long-acting human insulins + Subetta (1 tablet 4 times a day). Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nSubetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Short-acting and Long-acting human insulins + Placebo (1 tablet 4 times a day). Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nPlacebo'}], 'classes': [{'title': '4 weeks', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': '8 weeks', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '18 weeks', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '30 weeks', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': '36 weeks', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7344', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with "treatment" factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\\*visit interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4, 8, 12, 18, 24, 30 and 36 weeks of the treatment', 'description': 'A 7-point patient self-monitoring of blood glucose (SMBG):\n\nthree measurements of blood glucose before the meal; three measurements of postprandial blood glucose (1-2 h after the start of the meal) and one measurement at 3:00 a.m.', 'unitOfMeasure': 'mmol / l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat. 2 patients (1 in Subetta group and 1 in Placebo group) was excluded from the analysis due to lake of diaries'}, {'type': 'SECONDARY', 'title': 'Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subetta', 'description': 'Short-acting and Long-acting human insulins + Subetta (1 tablet 4 times a day). Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nSubetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Short-acting and Long-acting human insulins + Placebo (1 tablet 4 times a day). Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nPlacebo'}], 'classes': [{'title': 'Total cholesterol (12 weeks)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Total cholesterol (24 weeks)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Total cholesterol (36 weeks)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'HDL cholesterol (12 weeks)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'HDL cholesterol (24 weeks)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'HDL cholesterol (36 weeks)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'LDL cholesterol (12 weeks)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'LDL cholesterol (24 weeks)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'LDL cholesterol (36 weeks)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides (12 weeks)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides (24 weeks)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides (36 weeks)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2780', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\\*visit interaction.', 'groupDescription': 'Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8114', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\\*visit interaction.', 'groupDescription': 'Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1619', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\\*visit interaction.', 'groupDescription': 'Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0764', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\\*visit interaction.', 'groupDescription': 'Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12, 24 and 36 weeks of the treatment', 'description': 'Blood samples (for measurement of fasting plasma glucose, concentrations of plasma total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) are taken under standard conditions: after night break in food taking (at least 12 hours) and prior to administering of insulin morning dose (prandial), prior to any morning medicines intake (including the study drug and permitted concomitant therapy).', 'unitOfMeasure': 'mmol / l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat set'}, {'type': 'SECONDARY', 'title': 'Changes in Dosage of Insulin (Basal, Prandial and Total Daily Dose Insulin Measured in IU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subetta', 'description': 'Short-acting and Long-acting human insulins + Subetta (1 tablet 4 times a day). Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nSubetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Short-acting and Long-acting human insulins + Placebo (1 tablet 4 times a day). Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nPlacebo'}], 'classes': [{'title': 'Basal insulin (36 weeks)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Prandial insulin (36 weeks)', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Total daily dose insulin (36 weeks)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3107', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.', 'groupDescription': 'Analysis of basal insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5236', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.', 'groupDescription': 'Analysis of prandial insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3847', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.', 'groupDescription': 'Analysis of total daily dose insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 36 weeks of the treatment', 'description': 'Insulin dose should be corrected by a patient on a daily basis taking into consideration data on blood glucose self- monitoring during a day and amount of food carbohydrates. Physician can correct insulin dose based on the same data.', 'unitOfMeasure': 'IU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat set'}, {'type': 'SECONDARY', 'title': 'Changes in Dosage of Total Insulin Measured in IU/kg of Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subetta', 'description': 'Standard therapy of type I diabetes mellitus + Subetta (1 tablet 4 times a day).\n\nSubetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nSubetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Standard therapy of type I diabetes mellitus + Placebo (1 tablet 4 times a day).\n\nPlacebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6716', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 36 weeks of the treatment', 'description': 'Insulin dose should be corrected by a patient on a daily basis taking into consideration data on blood glucose self- monitoring during a day and amount of food carbohydrates. Physician can correct insulin dose based on the same data.', 'unitOfMeasure': 'IU/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat set'}, {'type': 'SECONDARY', 'title': 'Satisfaction of Diabetes Treatment Based on Diabetes Treatment Satisfaction Questionnaire Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subetta', 'description': 'Short-acting and Long-acting human insulins + Subetta (1 tablet 4 times a day). Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nSubetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Short-acting and Long-acting human insulins + Placebo (1 tablet 4 times a day). Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nPlacebo'}], 'classes': [{'title': 'Satisfaction', 'categories': [{'measurements': [{'value': '9.7', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2484', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.', 'groupDescription': 'Analysis of total Treatment Satisfaction score at Week 36 endpoint between Subetta and Placebo treatment groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7610', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.', 'groupDescription': 'Analysis of "Perceived Hyperglycaemia" question at Week 36 endpoint between Subetta and Placebo treatment groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3714', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.', 'groupDescription': 'Analysis of "Perceived Hypoglycemia" question at Week 36 endpoint between Subetta and Placebo treatment groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '36 weeks of the treatment', 'description': 'The Diabetes Treatment Satisfaction Questionnaire allows to assess the degree of satisfaction with treatment for diabetes and its complications - retinopathy and nephropathy, how patients\' satisfaction and perceived hyper- and hypoglycemia have changed compared to the initial period (before the treatment).\n\nThe Diabetes Treatment Satisfaction Questionnaire contains six items scored on 7-point scales from +3 (equals "very satisfied") to -3 (equals "very dissatisfied"), with 0 (equals "no change"). These are summed to produce a total Treatment Satisfaction score. Two questions concerning "Perceived Hyperglycaemia" and "Perceived Hypoglycaemia" respectively, are calculated separately. According to these two items, low scores represent good perceived blood glucose control (+3 means "most of the time" of Hyperglycaemia or Hypoglycaemia whereas -3 means "none of the time" of Hyperglycaemia or Hypoglycaemia).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat set. 6 patients (1 in the Subetta group and 5 in the Placebo group) was excluded from the analysis due to lake of questionnaires.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subetta', 'description': 'Short-acting and Long-acting human insulins + Subetta (1 tablet 4 times a day). Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nSubetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Short-acting and Long-acting human insulins + Placebo (1 tablet 4 times a day). Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Do not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The study enrolled patients using intensive insulin regimen (Short-acting and Long-acting human insulins) with type 1 diabetes who were not meeting glycemic control (HbA1c\\>7.0%). Eligible patients were assessed by endocrinologists. The study was performed in 15 medical institutions in Russia from May 2013 to October 2015.', 'preAssignmentDetails': 'Selection procedures were carried out after participant enrollment to determine whether the patient could participate in the study in accordance with the inclusion/exclusion criteria.\n\nOf the 200 patients enrolled, 49 did not meet inclusion criteria after screening procedures, they were not randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Subetta', 'description': 'Short-acting and Long-acting human insulins + Subetta (1 tablet 4 times a day). Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nSubetta: Efficacy and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Short-acting and Long-acting human insulins + Placebo (1 tablet 4 times a day). Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '35.0', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '36.1', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '77.7', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '74.4', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '76.0', 'spread': '14.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intention-to-Treat set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-15', 'studyFirstSubmitDate': '2013-05-27', 'resultsFirstSubmitDate': '2017-11-07', 'studyFirstSubmitQcDate': '2013-05-30', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-01', 'studyFirstPostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the Mean Value of HbA1c', 'timeFrame': 'baseline and 12, 24 and 36 weeks of the treatment', 'description': 'The HbA1C test was performed using a method that is certified by the National Glycohemoglobin Standardization Program (NGSP) (www.ngsp.org) and standardized or traceable to the Diabetes Control and Complications Trial (DCCT) reference assay.'}], 'secondaryOutcomes': [{'measure': 'Change in Fasting Plasma Glucose (Based on the Data of Biochemical Analysis)', 'timeFrame': 'baseline and 4, 12, 24 and 36 weeks of the treatment'}, {'measure': 'Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG)', 'timeFrame': 'baseline and 4, 8, 12, 18, 24, 30 and 36 weeks of the treatment', 'description': 'A 7-point patient self-monitoring of blood glucose (SMBG):\n\nthree measurements of blood glucose before the meal; three measurements of postprandial blood glucose (1-2 h after the start of the meal) and one measurement at 3:00 a.m.'}, {'measure': 'Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides)', 'timeFrame': 'baseline and 12, 24 and 36 weeks of the treatment', 'description': 'Blood samples (for measurement of fasting plasma glucose, concentrations of plasma total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) are taken under standard conditions: after night break in food taking (at least 12 hours) and prior to administering of insulin morning dose (prandial), prior to any morning medicines intake (including the study drug and permitted concomitant therapy).'}, {'measure': 'Changes in Dosage of Insulin (Basal, Prandial and Total Daily Dose Insulin Measured in IU)', 'timeFrame': 'baseline and 36 weeks of the treatment', 'description': 'Insulin dose should be corrected by a patient on a daily basis taking into consideration data on blood glucose self- monitoring during a day and amount of food carbohydrates. Physician can correct insulin dose based on the same data.'}, {'measure': 'Changes in Dosage of Total Insulin Measured in IU/kg of Body Weight', 'timeFrame': 'baseline and 36 weeks of the treatment', 'description': 'Insulin dose should be corrected by a patient on a daily basis taking into consideration data on blood glucose self- monitoring during a day and amount of food carbohydrates. Physician can correct insulin dose based on the same data.'}, {'measure': 'Satisfaction of Diabetes Treatment Based on Diabetes Treatment Satisfaction Questionnaire Data', 'timeFrame': '36 weeks of the treatment', 'description': 'The Diabetes Treatment Satisfaction Questionnaire allows to assess the degree of satisfaction with treatment for diabetes and its complications - retinopathy and nephropathy, how patients\' satisfaction and perceived hyper- and hypoglycemia have changed compared to the initial period (before the treatment).\n\nThe Diabetes Treatment Satisfaction Questionnaire contains six items scored on 7-point scales from +3 (equals "very satisfied") to -3 (equals "very dissatisfied"), with 0 (equals "no change"). These are summed to produce a total Treatment Satisfaction score. Two questions concerning "Perceived Hyperglycaemia" and "Perceived Hypoglycaemia" respectively, are calculated separately. According to these two items, low scores represent good perceived blood glucose control (+3 means "most of the time" of Hyperglycaemia or Hypoglycaemia whereas -3 means "none of the time" of Hyperglycaemia or Hypoglycaemia).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Combined treatment of patients with type I diabetes mellitus'], 'conditions': ['Type I Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '29807102', 'type': 'DERIVED', 'citation': 'Mkrtumyan A, Romantsova T, Vorobiev S, Volkova A, Vorokhobina N, Tarasov S, Putilovskiy M, Andrianova E, Epstein O. Efficacy and safety of Subetta add-on therapy in type 1 diabetes mellitus: The results of a multicenter, double-blind, placebo-controlled, randomized clinical trial. Diabetes Res Clin Pract. 2018 Aug;142:1-9. doi: 10.1016/j.diabres.2018.04.044. Epub 2018 May 26.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Patients with type I diabetes mellitus are included in the trial. It is concerned those patients, who by the time of the trial receive basal bolus insulin therapy of type I diabetes mellitus, including basal insulin (using long acting medications) and prandial insulin (short and ultra short acting medications), and with poor glycemic control (HbA1c=7.0-10.0%). For patients, which will be included in the trial (mainly middle aged patients without severe complications of diabetes), HbA1c\\>7.0% is the marker showing that optimal individual goal of glycemic control is not achieved.\n\nHbA1c, fasting plasma glucose, microalbuminuria, estimated glomerular filtration rate, ophthalmoscopy, blood pressure measurement, patient self-monitoring of blood glucose, frequency of hypoglycemia, endocrinologist examination were performed within screening period. Patients without severe diabetes complications are randomized in 2 groups.\n\nIf a patient meets inclusion criteria and does not show exclusion criteria he/she is randomized in one of 2 groups: Group 1 - patients receiving standard type I diabetes mellitus therapy + Subetta at a dose of 1 tablet 4 times a day; Group 2 - the group receiving standard type I diabetes mellitus therapy + Placebo under the regimen used for Subetta. The invented names of the drugs containing basal and prandial (meal) insulin should be unchanged for each patient during the whole trial.\n\nAll patients will receive glucometers and the appropriate glucose test strips, so they could self monitor blood glucose and register this data in their diaries.\n\nThe trial duration is 38 weeks; the main stages of the trial are conducted during screening, then in 4 weeks (Visit 2), in 12 weeks (Visit 3), in 24 weeks (Visit 4) and in 36 weeks (Visit 5). In 1 week after randomization and the onset of the trial therapy and between the visits to the study site (on weeks 8±1, 18±1 and 30±1) an investigator collects data on patient's health and complaints (phone visits) to decide whether it is necessary to arrange unplanned visit to the site."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/ min/1.73m\\^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 2/3 bundle branches;\n * WPW syndrome;\n * ventricular arrhythmia of III grade according Laun-Wolf;\n * paroxysmal supraventricular tachycardia;\n * paroxysmal/recurrent 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/or 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/m2), renal insufficiency, liver failure.\n8. Medical history of pancreatectomy or transplantation of pancreatic/islet cells.\n9. Medical history of renal transplantation.\n10. Malignant neoplasms/suspected 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/L.\n13. Medical history of bariatric surgical operations.\n14. Medical history of polyvalent allergy.\n15. Allergy/ 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/wife, 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.'}, 'identificationModule': {'nctId': 'NCT01868594', 'briefTitle': 'Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Materia Medica Holding'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MMH-SU-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subetta group', 'description': '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', 'interventionNames': ['Drug: Subetta']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': '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.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Subetta', 'type': 'DRUG', 'description': '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).', 'armGroupLabels': ['Subetta group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '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).', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111123', 'city': 'Moscow', 'country': 'Russia', 'facility': 'State Healthcare Institution of Moscow "Central research institute of gastroenterology" of Department of health care of Moscow', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129128', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Nonstate Health Care Institution "Central Clinical Hospital №2 named after N.A. Semashko of Public Limited Company "Russian Railways"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '141400', 'city': 'Moscow Region', 'country': 'Russia', 'facility': 'Municipal budgetary authority "Khimki Central Clinical Hospital"'}, {'zip': '603011', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'The State Budgetary Institution of Health Care of the Nizhny Novgorod Region "City clinical hospital No. 10 "', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '603126', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Nizhny Novgorod regional State Budgetary Health Institution " Nizhny Novgorod regional Clinical Hospital named after N.A. Semashko "', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '344022', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'State Budgetary Educational Institution of High Professional Training "Rostov State Medical University" of Ministry of Health of Russian Federation, Department of Endocrinology', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '190013', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Private company "Polyclinic Complex"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '191482', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg State Budgetary Health Care Institution "City Polyclinic №6"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '195257', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg State Budgetary Health Care Institution "Saint Venerable Martyr Elizaveta Municipal Hospital"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': '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', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197183', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg Sate Budgetary Institution "Consultative-Diagnostic Polyclinic №1 of Coastal Area"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443067', 'city': 'Samara', 'country': 'Russia', 'facility': 'Co.Ltd " Diabet Center"', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '394018', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Independent Health Care Institution of Voronezh Region "Voronezh Regional Clinical Consultative-Diagnostic Center"', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '150062', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'State Budgetary Health Care Institution of Yaroslavl Region "Regional Сlinical Hospital"', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Materia Medica Holding', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}