Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-01 @ 3:53 PM
Study NCT ID:
NCT03725033
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2018-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608938', 'term': 'subetta'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PutilovskiyMA@materiamedica.ru', 'phone': '+74952761571', 'title': 'Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director', 'phoneExt': '302', 'organization': 'MATERIA MEDICA HOLDING'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During the study - 12 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Subetta', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 15, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 20, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain in the abdomen', 'notes': 'Pain in the upper abdomen (in the hypochondrium)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increase of leukocytes in the urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increase of alanine aminotransferase levels', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increase of aspartate aminotransferase level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increase of glycated hemoglobin level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increase of blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Postprandial hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'notes': 'Nasal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'notes': 'Knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deterioration of the condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Unsteadiness of gait', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Concussion of the brain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Soft tissue injury', 'notes': 'Contusion of the soft tissues of the right thigh', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subetta', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.\n\nSubetta: Oral administration.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.\n\nPlacebo: Oral administration.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.27', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '9.11', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'After 12 weeks', 'categories': [{'measurements': [{'value': '7.28', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '8.32', 'spread': '2.44', 'groupId': 'OG001'}]}]}, {'title': '∆ between baseline and after 12 weeks', 'categories': [{'measurements': [{'value': '-1.99', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '2.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0028', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to ∆ between baseline and after 12 weeks row.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 12 weeks of treatment.', 'description': 'Based on medical records. For oral glucose tolerance test, the subject is given 75 g of oral glucose and blood sample is taken 2 hours later. All analysis will be done in a central laboratory.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 randomized patients who received full treatment and underwent all procedures according to the protocol (n = 4, Subetta group; n = 5, Placebo group) were excluded from analysis. Blood samples were obtained but the central laboratory did not provide carbohydrate metabolism values due to technical reasons for these patients.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subetta', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0805', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 12 weeks of treatment.', 'description': 'Based on medical records.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '9 randomized patients who received full treatment and underwent all procedures according to the protocol (n = 4, Subetta group; n = 5, Placebo group) were excluded from analysis. Blood samples were obtained but the central laboratory did not provide carbohydrate metabolism values due to technical reasons for these patients.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subetta', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.83', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '5.88', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'After 12 weeks', 'categories': [{'measurements': [{'value': '6.01', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '6.02', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': '∆ between baseline and after 12 weeks', 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '1.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to ∆ between baseline and after 12 weeks row.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 12 weeks of treatment.', 'description': 'Based on medical records. Fasting plasma glucose is measured after fasting or not eating anything for at least 8 hours.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 randomized patients who received full treatment and underwent all procedures according to the protocol (n = 4, Subetta group; n = 5, Placebo group) were excluded from analysis. Blood samples were obtained but the central laboratory did not provide carbohydrate metabolism values due to technical reasons for these patients.'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subetta', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '6.1'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.85', 'upperLimit': '6.2'}]}]}, {'title': 'After 12 weeks', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '6.0'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '6.05'}]}]}, {'title': '∆ between baseline and after 12 weeks', 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '-0.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '-0.1'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to ∆ between baseline and after 12 weeks row.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline and after 12 weeks of treatment.', 'description': 'Based on medical records. HbA1c is determined by the method certified in accordance with National Glycohemoglobin Standardization Program and standardized in compliance with the reference values adopted in the Diabetes Control and Complications Trial.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '9 randomized patients who received full treatment and underwent all procedures according to the protocol (n = 4, Subetta group; n = 5, Placebo group) were excluded from analysis. Blood samples were obtained but the central laboratory did not provide carbohydrate metabolism values due to technical reasons for these patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subetta', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'After screening procedures 336 patients were excluded by the researchers because they did not meet the inclusion criteria, or they had non-inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Subetta', 'description': 'Oral administration. 2 tablets 2 times a day 15 minutes before meals. Keep the tablets in your mouth, not swallowing, until completely they are dissolved.\n\nSubetta: For oral use.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Oral administration. 2 tablets 2 times a day 15 minutes before meals. Keep the tablets in your mouth, not swallowing, until completely they are dissolved.\n\nPlacebo: For oral use.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.6', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '56.1', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '56.4', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-30', 'size': 269628, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-18T04:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 538}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2018-10-29', 'resultsFirstSubmitDate': '2020-12-18', 'studyFirstSubmitQcDate': '2018-10-29', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-18', 'studyFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test).', 'timeFrame': 'At baseline and after 12 weeks of treatment.', 'description': 'Based on medical records. For oral glucose tolerance test, the subject is given 75 g of oral glucose and blood sample is taken 2 hours later. All analysis will be done in a central laboratory.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L.', 'timeFrame': 'After 12 weeks of treatment.', 'description': 'Based on medical records.'}, {'measure': 'Change in Fasting Plasma Glucose.', 'timeFrame': 'At baseline and after 12 weeks of treatment.', 'description': 'Based on medical records. Fasting plasma glucose is measured after fasting or not eating anything for at least 8 hours.'}, {'measure': 'Change in HbA1c', 'timeFrame': 'At baseline and after 12 weeks of treatment.', 'description': 'Based on medical records. HbA1c is determined by the method certified in accordance with National Glycohemoglobin Standardization Program and standardized in compliance with the reference values adopted in the Diabetes Control and Complications Trial.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Impaired Glucose Tolerance']}, 'descriptionModule': {'briefSummary': 'Purpose of the study:\n\n* to assess the efficacy of Subetta in the treatment of impaired glucose tolerance\n* to assess the safety of Subetta in the treatment of impaired glucose tolerance.', 'detailedDescription': 'Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized trial.\n\nThe study will enroll outpatients adults aged 18 to 70 years with impaired glucose tolerance (IGT) who did not receive glucose-lowering agents previously. Persons with pre-diabetes, obesity (especially with visceral or abdominal obesity), dyslipidemia (with high triglycerides and/or low-density lipoproteins), hypertension, diabetes in first-degree relatives will be considered as potential candidates to participate in the study.\n\nAfter the patient\'s information sheet and the form of informed consent for participation in the study are signed on the screening (visit 0; day from -7 to 0), complaints and history are collected, registration of concomitant conditions and diseases, objective examination, calculation of body mass index (BMI), oral glucose tolerance test (OGTT), fasting blood glucose. Furthermore, blood samples (for testing HbA1c, chemistry and hematology, HLA genotyping) and urine sample will be collected; concomitant therapy will be recorded, diet and physical activity recommendations will be given. All women of childbearing potential will be administered pregnancy tests.\n\nIf eligibility criteria are met and there are no non-inclusion criteria on Visit 1 (Day 1), the patient is randomized to one of two groups: the Subetta group (patients will take 2 tablets twice a day for 12 weeks) or placebo group (patients will take a placebo according to the scheme of Subetta for 12 weeks).\n\nIn the course of the study, two more visits in 4 (Visit 2) and 12 (Visit 3) weeks are planned, during these weeks complaints are recorded, a patient\'s examination is recorded, therapy compliance and safety are assessed. On Visit 3 OGTT, fasting blood glucose, blood samples (for HbA1c, chemistry and hematology) and urinalysis will be performed.\n\nThe duration of observation period shall be up to 13 weeks. During the study the treatment for underlying conditions will be allowed with the exception of the drugs indicated in the section "Prohibited concomitant therapy".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Outpatients aged 18 to 70 years.\n2. Impaired glucose tolerance (plasma glucose from 7.8 to 11.0 mmol / L 2 hours after a 75 g oral glucose consumption during an oral glucose tolerance test, while fasting plasma glucose \\<7.0 mmol / L).\n3. HbA1c is 5.7-6.4%.\n4. The body mass index is 25.0-39.9 kg / m\\^2.\n5. Consent to use reliable contraceptive methods during the study (for men and women with reproductive potential).\n6. The presence of the signed informed consent form to participate in the clinical trial.\n\nExclusion Criteria:\n\n1. Type 1 or type 2 diabetes.\n2. Use of any medications indicated in the section "Prohibited concomitant medications".\n3. Acute or exacerbation / decompensation of a chronic disease of any etiology at the time of the examination or during the previous week.\n4. Uncontrolled arterial hypertension with blood pressure: systolic blood pressure \\> 160 mm Hg and/or diastolic blood pressure \\> 110 mm Hg.\n5. Acute coronary syndrome, myocardial infarction, acute impairment of cerebral circulation during the previous 6 months prior to enrollment.\n6. Unstable or life-threatening arrhythmia during the previous 3 months prior to enrollment.\n7. Acute and chronic heart failure with functional class III or IV (according to the classification of the New York Heart Association, 1964).\n8. Respiratory failure.\n9. Chronic kidney disease (classes C3-5 A3).\n10. Hepatic insufficiency (class C according to Child-Pugh).\n11. Presence or suspicion of oncology disease.\n12. The presence of an allergy / hypersensitivity to any component of the medication administered during the treatment.\n13. Alcohol consumption \\> 2 alcohol units for males and \\> 1 alcohol unit for females per day.\n14. Mental illness or drug abuse in anamnesis.\n15. Bariatric surgery in anamnesis, any surgery for 3 months before enrollment.\n16. Pregnancy, breast-feeding; childbirth less than 3 months before enrollment.\n17. Participation in other clinical trials for 3 months before enrollment in this study.\n18. Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. \'Immediate relative\' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).\n19. Patients who work for MATERIA MEDICA HOLDING (i.e. the company\'s employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).'}, 'identificationModule': {'nctId': 'NCT03725033', 'briefTitle': 'Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance', '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 Treatment of Impaired Glucose Tolerance', 'orgStudyIdInfo': {'id': 'MMH-SU-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subetta', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.', 'interventionNames': ['Drug: Subetta']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Subetta', 'type': 'DRUG', 'description': 'Oral administration.', 'armGroupLabels': ['Subetta']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Arkhangelsk Regional Clinical Hospital', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '308015', 'city': 'Belgorod', 'country': 'Russia', 'facility': 'Belgorod State National Research University', 'geoPoint': {'lat': 50.60343, 'lon': 36.58091}}, {'zip': '610014', 'city': 'Kirov', 'country': 'Russia', 'facility': 'Kirov Clinical Hospital № 7 named. V.I. Yurlova', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'zip': '350063', 'city': 'Krasnodar', 'country': 'Russia', 'facility': 'Kuban State Medical University', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'zip': '350086', 'city': 'Krasnodar', 'country': 'Russia', 'facility': 'Regional Clinical Hospital #1 named after Professor Ochapovsky', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'zip': '143405', 'city': 'Krasnogorsk', 'country': 'Russia', 'facility': 'Clinic of Professor Gorbakov', 'geoPoint': {'lat': 55.81904, 'lon': 37.32984}}, {'zip': '143408', 'city': 'Krasnogorsk', 'country': 'Russia', 'facility': 'Krasnogorsk city hospital №1', 'geoPoint': {'lat': 55.81904, 'lon': 37.32984}}, {'zip': '105187', 'city': 'Moscow', 'country': 'Russia', 'facility': 'City Clinical Hospital named after F.I. 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I. Razumovsky', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '400131', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'Volgograd State Medical University', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'zip': '394018', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Voronezh Regional Clinical Consultative and Diagnostic Center', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '150003', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'LLC "Medical Consultations and Research Center - PRACTICE"', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '150062', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'The State Budgetary Healthcare Institution of the Yaroslavl Region "Regional Clinical Hospital"', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '620026', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Ural State Medical University', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '620102', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'City Clinical Hospital #40', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '620137', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Central City Hospital #7', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Materia Medica Holding', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}