Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-11 @ 10:17 AM
Study NCT ID:
NCT02079805
Status:
COMPLETED
Last Update Posted:
2017-08-02
First Post:
2014-03-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C521273', 'term': 'azilsartan'}, {'id': 'D000077333', 'term': 'Telmisartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 12', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Telmisartan 40 mg', 'description': 'Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.', 'otherNumAtRisk': 16, 'otherNumAffected': 8, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Azilsartan 20 mg', 'description': 'Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.', 'otherNumAtRisk': 17, 'otherNumAffected': 6, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cutaneous amyloidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 40 mg', 'description': 'Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}, {'id': 'OG001', 'title': 'Azilsartan 20 mg', 'description': 'Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.928', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '2.449', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '1.78', 'groupDescription': 'Telmisartan 40 mg, Azilsartan 20 mg', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from the start of the treatment period (baseline) at the end of the treatment period (Week 12) was reported. Insulin Resistance Index (HOMA-R) measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405).', 'unitOfMeasure': 'HOMA-R Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Blood Glucose From Baseline at the End of the Treatment Period (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 40 mg', 'description': 'Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}, {'id': 'OG001', 'title': 'Azilsartan 20 mg', 'description': 'Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.06', 'spread': '14.991', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '18.308', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline in fasting blood glucose values collected at week 12 or final visit relative to baseline was reported.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Insulin From Baseline at the End of the Treatment Period (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 40 mg', 'description': 'Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}, {'id': 'OG001', 'title': 'Azilsartan 20 mg', 'description': 'Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.818', 'spread': '2.7623', 'groupId': 'OG000'}, {'value': '0.475', 'spread': '6.3847', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline in fasting insulin values collected at week 12 or final visit relative to baseline was reported.', 'unitOfMeasure': 'µU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in Glycosylated Hemoglobin (HbA1c) From Baseline at the End of the Treatment Period (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 40 mg', 'description': 'Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}, {'id': 'OG001', 'title': 'Azilsartan 20 mg', 'description': 'Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '0.290', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.382', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline in the values of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline was reported.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-β) From Baseline at the End of the Treatment Period (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 40 mg', 'description': 'Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}, {'id': 'OG001', 'title': 'Azilsartan 20 mg', 'description': 'Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.88', 'spread': '20.151', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '30.985', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline in HOMA-β collected at week 12 or final visit relative to baseline was reported. Homeostasis model assessment of beta cell function measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in 1,5-anhydroglucitol (1,5-AG) From Baseline at the End of the Treatment Period (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 40 mg', 'description': 'Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}, {'id': 'OG001', 'title': 'Azilsartan 20 mg', 'description': 'Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.24', 'spread': '2.143', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '2.454', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline in 1,5-G concentration collected at week 12 or final visit relative to baseline was reported.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 40 mg', 'description': 'Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}, {'id': 'OG001', 'title': 'Azilsartan 20 mg', 'description': 'Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 12', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Telmisartan 40 mg', 'description': 'Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}, {'id': 'FG001', 'title': 'Azilsartan 20 mg', 'description': 'Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Pretreatment Event/Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 27 investigative sites in Japan, from 04 June 2014 to 25 April 2016.', 'preAssignmentDetails': 'Participants with diagnosis of type 2 diabetes mellitus were enrolled in 2 treatment group: Azilsartan 20 mg, and Telmisartan 40 mg for 12 weeks as treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Telmisartan 40 mg', 'description': 'Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}, {'id': 'BG001', 'title': 'Azilsartan 20 mg', 'description': 'Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.3', 'spread': '9.10', 'groupId': 'BG000'}, {'value': '63.2', 'spread': '12.76', 'groupId': 'BG001'}, {'value': '64.2', 'spread': '11.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '70.95', 'spread': '16.689', 'groupId': 'BG000'}, {'value': '70.41', 'spread': '14.878', 'groupId': 'BG001'}, {'value': '70.67', 'spread': '15.534', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.18', 'spread': '3.720', 'groupId': 'BG000'}, {'value': '27.19', 'spread': '4.642', 'groupId': 'BG001'}, {'value': '27.19', 'spread': '4.154', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Classification', 'classes': [{'title': 'Never smoked', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol Classification', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants who answered Yes or No for a question "Drik Alcohol Almost Everyday?" were reported.', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Hypertention', 'classes': [{'categories': [{'measurements': [{'value': '4.71', 'spread': '4.391', 'groupId': 'BG000'}, {'value': '3.54', 'spread': '4.392', 'groupId': 'BG001'}, {'value': '4.11', 'spread': '4.363', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes Mellitus', 'classes': [{'categories': [{'measurements': [{'value': '4.53', 'spread': '4.279', 'groupId': 'BG000'}, {'value': '4.89', 'spread': '5.039', 'groupId': 'BG001'}, {'value': '4.72', 'spread': '4.617', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Taking Biguanides', 'classes': [{'title': 'Had taken', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Not had taken', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants who had taken biguanides when study started were reported.', 'unitOfMeasure': 'participants'}, {'title': 'Insulin Resistance Index (HOMA-R)', 'classes': [{'categories': [{'measurements': [{'value': '3.31', 'spread': '1.366', 'groupId': 'BG000'}, {'value': '4.24', 'spread': '1.843', 'groupId': 'BG001'}, {'value': '3.79', 'spread': '1.671', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Insulin Resistance Index (HOMA-R) measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.', 'unitOfMeasure': 'HOMA-R Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood Pressure Systolic Mean', 'classes': [{'categories': [{'measurements': [{'value': '145.6', 'spread': '9.91', 'groupId': 'BG000'}, {'value': '143.3', 'spread': '9.28', 'groupId': 'BG001'}, {'value': '144.4', 'spread': '9.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood Pressure Diastolic Mean', 'classes': [{'categories': [{'measurements': [{'value': '89.3', 'spread': '10.61', 'groupId': 'BG000'}, {'value': '88.8', 'spread': '7.19', 'groupId': 'BG001'}, {'value': '89.0', 'spread': '8.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated Hemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '6.63', 'spread': '0.411', 'groupId': 'BG000'}, {'value': '6.81', 'spread': '0.488', 'groupId': 'BG001'}, {'value': '6.72', 'spread': '0.454', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Glycosylated Hemoglobin (HbA1c) were caluculated by the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound.', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Randomized Set included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2014-03-04', 'resultsFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-24', 'studyFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from the start of the treatment period (baseline) at the end of the treatment period (Week 12) was reported. Insulin Resistance Index (HOMA-R) measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405).'}], 'secondaryOutcomes': [{'measure': 'Change in Fasting Blood Glucose From Baseline at the End of the Treatment Period (Week 12)', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline in fasting blood glucose values collected at week 12 or final visit relative to baseline was reported.'}, {'measure': 'Change in Fasting Insulin From Baseline at the End of the Treatment Period (Week 12)', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline in fasting insulin values collected at week 12 or final visit relative to baseline was reported.'}, {'measure': 'Change in Glycosylated Hemoglobin (HbA1c) From Baseline at the End of the Treatment Period (Week 12)', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline in the values of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline was reported.'}, {'measure': 'Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-β) From Baseline at the End of the Treatment Period (Week 12)', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline in HOMA-β collected at week 12 or final visit relative to baseline was reported. Homeostasis model assessment of beta cell function measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.'}, {'measure': 'Change in 1,5-anhydroglucitol (1,5-AG) From Baseline at the End of the Treatment Period (Week 12)', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline in 1,5-G concentration collected at week 12 or final visit relative to baseline was reported.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events', 'timeFrame': 'Up to Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Essential Hypertension Complicated by Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '30943275', 'type': 'DERIVED', 'citation': 'Naruse M, Koike Y, Kamei N, Sakamoto R, Yambe Y, Arimitsu M. Effects of azilsartan compared with telmisartan on insulin resistance in patients with essential hypertension and type 2 diabetes mellitus: An open-label, randomized clinical trial. PLoS One. 2019 Apr 3;14(4):e0214727. doi: 10.1371/journal.pone.0214727. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter, randomized, open-label, parallel-group exploratory study to explore the effects of azilsartan (Azirva), compared with telmisartan, on insulin resistance in participants with essential hypertension complicated by type 2 diabetes mellitus', 'detailedDescription': 'The primary objective of the present study is to explore the effects of azilsartan 20 mg, compared with telmisartan 40 mg, once daily orally for 12 weeks on insulin resistance in participants with essential hypertension complicated by type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The participant was given the diagnosis of grade I or II essential hypertension and was judged by the principal investigator or investigator that they can be appropriately treated with azilsartan 20 mg and telmisartan 40 mg.\n2. Sitting systolic blood pressure of ≥ 130 mmHg and \\< 180 mmHg or sitting diastolic blood pressure of ≥ 80 mmHg and \\< 110 mmHg at the start of the treatment period (Week 0) Sitting blood pressure will be measured until 2 consecutive stable measurements are obtained (i.e., the difference between 2 measurements: diastolic blood pressure of \\<5 mmHg and systolic blood pressure of \\< 10 mmHg) after resting in a sitting position for at least 5 minutes. The average value of the last 2 measurements will be recorded (the first the decimal place is rounded off).\n3. Type 2 diabetes mellitus\n4. HbA1c (NGSP (National Glycohemoglobin Standardization Program) value) of \\< 8.4% during 3 months before informed consent, with a ≤ 0.3% change in HbA1c (peak minus nadir) during 3 months before informed consent\n5. No change in diet/exercise therapy during the 3 months before the informed consent in a participant who has been on diet/exercise therapy and instructed to improve life style (e.g., diet and exercise)\n6. Age ≥ 20 years at the time of consent\n7. Outpatients\n8. Capable of providing written consent before participation in this study.\n\nExclusion Criteria:\n\n1. Grade III essential hypertension (i.e., sitting systolic blood pressure 180 mmHg or sitting diastolic blood pressure ≥ 110 mmHg), secondary hypertension, or malignant hypertension.\n2. Grade II essential hypertension (i.e., sitting systolic blood pressure ≥ 160 mmHg or sitting diastolic blood pressure ≥ 100 mmHg) for which antihypertensive drug(s) are used\n3. Use of oral antihypertensive medication within 2 weeks before the start of the treatment period Participants who are on any antihypertensive agent at the time of informed consent can be enrolled in the study only after 2-week washout following informed consent.\n4. Use of RAS inhibitors or thiazolidines within 3 months before the start of the treatment period\n5. Type 1 diabetes mellitus\n6. Fasting blood glucose of \\< 180 mg/dL and HOMA-R of ≤ 1.6 at the start of the treatment period (Week 0)\n7. Receiving or requiring any of the following at the time of informed consent:\n\n * Insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, or other parenteral hypoglycemic agents\n * Combination therapy with 3 or more oral hypoglycemic agents\n8. Change of antidiabetic medication (including dosage change) within 3 months before the start of the treatment period\n9. Having diagnosed/treated any of the following cardiovascular diseases within 3 months before the start of the treatment period:\n\n * Cardiac disease/condition: myocardial infarction, coronary revascularization procedure\n * Cerebrovascular disease: cerebral infarction, cerebral haemorrhage, transient ischaemic attack\n * Advanced hypertensive retinopathy (retinal bleeding or oozing, papilloedema)\n10. Having diagnosed/treated for any of the following cardiovascular diseases more than 3 months before the start of the treatment period, and is now still in unstable condition.\n\n * Cardiac disease/condition: myocardial infarction, coronary revascularization procedure\n * Cerebrovascular disease: cerebral infarction, cerebral haemorrhage, transient ischaemic attack\n11. Past or current history of any of the following cardiovascular diseases.\n\n * Cardiac valve stenosis\n * Angina pectoris requiring medication\n * Congestive cardiac failure requiring medication\n * Arrhythmia requiring medication (e.g., paroxysmal atrial fibrillation, severe bradycardia, torsade de pointes, and ventricular fibrillation)\n * Arteriosclerosis obliterans with intermittent claudication or other symptoms\n12. Have severe ketosis, diabetic coma or precoma, severe infection, or serious trauma\n13. Clinically evident renal disorder (e.g., eGFR \\<30 mL/min/1.73 m2)\n14. Markedly low bile secretion or severe hepatic disorder\n15. History of hypersensitivity or allergy to azilsartan or telmisartan or to both.\n16. Presence of hyperkalemia (potassium level ≥ 5.5 mEq/L on laboratory testing)\n17. Currently participating in any other clinical study.\n18. Pregnant women, women with possible pregnancy, or breast-feeding women.\n19. Other participants who are inappropriate for participation in this study in the opinion of the principal investigator or investigator.'}, 'identificationModule': {'nctId': 'NCT02079805', 'briefTitle': 'A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R', 'orgStudyIdInfo': {'id': '279/NRP-001'}, 'secondaryIdInfos': [{'id': 'U1111-1151-7168', 'type': 'REGISTRY', 'domain': 'UTN (WHO)'}, {'id': 'AZI-P4-004', 'type': 'OTHER', 'domain': 'Takeda'}, {'id': 'JapicCTI-142461', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azilsartan 20 mg', 'description': 'Participants will receive azilsartan 20 mg once daily in the morning before or after breakfast.', 'interventionNames': ['Drug: Azilsartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telmisartan 40 mg', 'description': 'Participants will receive telmisartan 40 mg once daily in the morning before or after breakfast.', 'interventionNames': ['Drug: Telmisartan']}], 'interventions': [{'name': 'Azilsartan', 'type': 'DRUG', 'otherNames': ['Azilva Tablets'], 'description': 'Azilsartan tablets', 'armGroupLabels': ['Azilsartan 20 mg']}, {'name': 'Telmisartan', 'type': 'DRUG', 'otherNames': ['Micardis Tablets'], 'description': 'Telmisartan tablets', 'armGroupLabels': ['Telmisartan 40 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}], 'overallOfficials': [{'name': 'General Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}