{"protocolSection":{"identificationModule":{"nctId":"NCT01232946","orgStudyIdInfo":{"id":"1105005578"},"organization":{"fullName":"Indiana University","class":"OTHER"},"briefTitle":"Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake","officialTitle":"Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake"},"statusModule":{"statusVerifiedDate":"2019-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-01"},"primaryCompletionDateStruct":{"date":"2017-09-08","type":"ACTUAL"},"completionDateStruct":{"date":"2017-09-08","type":"ACTUAL"},"studyFirstSubmitDate":"2010-11-01","studyFirstSubmitQcDate":"2010-11-01","studyFirstPostDateStruct":{"date":"2010-11-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-02-18","resultsFirstSubmitQcDate":"2019-08-05","resultsFirstPostDateStruct":{"date":"2019-08-07","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-08-05","lastUpdatePostDateStruct":{"date":"2019-08-07","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Kieren Mather","investigatorTitle":"Professor of Medicine","investigatorAffiliation":"Indiana University"},"leadSponsor":{"name":"Indiana University","class":"OTHER"},"collaborators":[{"name":"Novo Nordisk A/S","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a background of metformin 2000 mg per day. After 3 months' treatment, PET measurements of myocardial fuel selection will take place, under fasting conditions in the morning following that day's treatment injection(s).","detailedDescription":"The investigators will test the hypothesis that effects of liraglutide plus insulin detemir on myocardial fuel selection will be greater than the effects of either agent alone. 27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group). All subjects will undergo an initial standardization of background treatment to metformin 2000 mg per day, followed by randomized assignment to 3 months' treatment with liraglutide 1.8 mg/day (once daily each morning, tapering up according to label instructions) and/or detemir (administered twice daily, initially at 10 units per day then titrated to achieve fasting morning glucose readings below 130 mg/dL). PET measurements of myocardial fuel selection will take place at the end of this treatment period, under fasting conditions in the morning following that day's treatment injection(s)."},"conditionsModule":{"conditions":["Type 2 Diabetes"],"keywords":["Diabetes","Myocardial metabolism"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"OTHER","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":30,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Iiraglutide","type":"EXPERIMENTAL","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.","interventionNames":["Drug: liraglutide"]},{"label":"insulin detemir","type":"EXPERIMENTAL","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.","interventionNames":["Drug: insulin detemir"]},{"label":"Liraglutide plus insulin detemir","type":"EXPERIMENTAL","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.","interventionNames":["Drug: liraglutide plus insulin detemir"]}],"interventions":[{"type":"DRUG","name":"liraglutide","description":"1.8mg subcutaneous qd for 3 months","armGroupLabels":["Iiraglutide"],"otherNames":["Victoza"]},{"type":"DRUG","name":"insulin detemir","description":"5units subcutaneous bid titrated to fasting glucose of \\<130mg/dL for 3 months","armGroupLabels":["insulin detemir"],"otherNames":["Levemir"]},{"type":"DRUG","name":"liraglutide plus insulin detemir","description":"liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \\<130mg/dL for 3 months.","armGroupLabels":["Liraglutide plus insulin detemir"],"otherNames":["Vyctoza plus Levemir"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Myocardial Glucose Uptake","description":"PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir","timeFrame":"3 months"},{"measure":"Myocardial Fatty Acid Oxidation Rate","description":"PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir","timeFrame":"3 months"},{"measure":"Myocardial Fatty Acid Esterification Rate","description":"PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir","timeFrame":"3 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 diabetic\n* 18-50 years\n* BMI \\> 25kg/m2\n* HbA1c 7.0-10.0%\n* Treated with up to 2 oral agents\n\nExclusion Criteria:\n\n* Chronic illness or infection (other than diabetes mellitus)\n* Known coronary artery disease, structural heart disease or abnormal ECG on screen.\n* Treatment with \\>2 antihypertensive agents or blood pressure \\>140/95 on two occasions during screening\n* History of claustrophobia, musculoskeletal or other factors which would result in an inability to comfortably remain within the PET scanner gantry for the duration of the imaging protocol.\n* Occupational, investigational or other known radiation exposure which together with the planned radiologic studies, will result in greater than 500 mrem total exposure in a 12 month period.\n* Current pregnancy\n* Treatment with GLP-1 agonist or DPP4 inhibitor within the past 6 months\n* Known intolerance to GLP-1 agonist\n* Personal history of pancreatitis, personal or family history of medullary thyroid carcinoma, or other contraindications to liraglutide treatment.\n* Recognized microvascular complications (neuropathy, nephropathy, retinopathy).","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"50 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Kieren J Mather, MD","affiliation":"Indiana University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Indiana Clinical Research Center","city":"Indianapolis","state":"Indiana","zip":"46202","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}}]},"referencesModule":{"references":[{"pmid":"30020461","type":"DERIVED","citation":"Mather KJ, Considine RV, Hamilton L, Patel NA, Mathias C, Territo W, Goodwill AG, Tune JD, Green MA, Hutchins GD. Combination GLP-1 and Insulin Treatment Fails to Alter Myocardial Fuel Selection vs. Insulin Alone in Type 2 Diabetes. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3456-3465. doi: 10.1210/jc.2018-00712."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Iiraglutide","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\nliraglutide: 1.8mg subcutaneous qd for 3 months"},{"id":"FG001","title":"Insulin Detemir","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\ninsulin detemir: 5units subcutaneous bid titrated to fasting glucose of \\<130mg/dL for 3 months"},{"id":"FG002","title":"Liraglutide Plus Insulin Detemir","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\nliraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \\<130mg/dL for 3 months."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"11"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","comment":"1 participant died unrelated to study","numSubjects":"9"},{"groupId":"FG002","comment":"2 withdrew after baseline measurements","numSubjects":"9"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Iiraglutide","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\nliraglutide: 1.8mg subcutaneous qd for 3 months"},{"id":"BG001","title":"Insulin Detemir","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\ninsulin detemir: 5units subcutaneous bid titrated to fasting glucose of \\<130mg/dL for 3 months"},{"id":"BG002","title":"Liraglutide Plus Insulin Detemir","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\nliraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \\<130mg/dL for 3 months."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"27"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53.9","spread":"5.3"},{"groupId":"BG001","value":"52.1","spread":"8.6"},{"groupId":"BG002","value":"49.2","spread":"9.0"},{"groupId":"BG003","value":"51.7","spread":"7.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"17"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"10"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"13"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"14"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"27"}]}]}]},{"title":"HbA1c, %","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"%","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7.59","spread":"0.96"},{"groupId":"BG001","value":"7.00","spread":"0.79"},{"groupId":"BG002","value":"8.13","spread":"0.99"},{"groupId":"BG003","value":"7.57","spread":"0.91"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Myocardial Glucose Uptake","description":"PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"umol/g/min","timeFrame":"3 months","groups":[{"id":"OG000","title":"Iiraglutide","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\nliraglutide: 1.8mg subcutaneous qd for 3 months"},{"id":"OG001","title":"Insulin Detemir","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\ninsulin detemir: 5units subcutaneous bid titrated to fasting glucose of \\<130mg/dL for 3 months"},{"id":"OG002","title":"Liraglutide Plus Insulin Detemir","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\nliraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \\<130mg/dL for 3 months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.055","lowerLimit":"0.0186","upperLimit":"0.1047"},{"groupId":"OG001","value":"0.0399","lowerLimit":"0.0129","upperLimit":"0.0494"},{"groupId":"OG002","value":"0.0373","lowerLimit":"0.0085","upperLimit":"0.0455"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.65","statisticalMethod":"Kruskal-Wallis"}]},{"type":"PRIMARY","title":"Myocardial Fatty Acid Oxidation Rate","description":"PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"umol/g/min","timeFrame":"3 months","groups":[{"id":"OG000","title":"Iiraglutide","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\nliraglutide: 1.8mg subcutaneous qd for 3 months"},{"id":"OG001","title":"Insulin Detemir","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\ninsulin detemir: 5units subcutaneous bid titrated to fasting glucose of \\<130mg/dL for 3 months"},{"id":"OG002","title":"Liraglutide Plus Insulin Detemir","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\nliraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \\<130mg/dL for 3 months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.1019","lowerLimit":"0.0803","upperLimit":"0.1399"},{"groupId":"OG001","value":"0.1234","lowerLimit":"0.0711","upperLimit":"0.1836"},{"groupId":"OG002","value":"0.0992","lowerLimit":"0.0801","upperLimit":"0.1352"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.065","statisticalMethod":"Kruskal-Wallis"}]},{"type":"PRIMARY","title":"Myocardial Fatty Acid Esterification Rate","description":"PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"umol/g/min","timeFrame":"3 months","groups":[{"id":"OG000","title":"Iiraglutide","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\nliraglutide: 1.8mg subcutaneous qd for 3 months"},{"id":"OG001","title":"Insulin Detemir","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\ninsulin detemir: 5units subcutaneous bid titrated to fasting glucose of \\<130mg/dL for 3 months"},{"id":"OG002","title":"Liraglutide Plus Insulin Detemir","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\nliraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \\<130mg/dL for 3 months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.00274","lowerLimit":"0.00236","upperLimit":"0.01234"},{"groupId":"OG001","value":"0.00358","lowerLimit":"0.00249","upperLimit":"0.00917"},{"groupId":"OG002","value":"0.00146","lowerLimit":"0.00038","upperLimit":"0.00863"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.80","statisticalMethod":"Kruskal-Wallis"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Study interval is ~4 months for each participant. Total study duration from first participant entered to last participant completed was ~3 yrs.","eventGroups":[{"id":"EG000","title":"Iiraglutide","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\nliraglutide: 1.8mg subcutaneous qd for 3 months","deathsNumAffected":0,"deathsNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"otherNumAffected":0,"otherNumAtRisk":9},{"id":"EG001","title":"Insulin Detemir","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\ninsulin detemir: 5units subcutaneous bid titrated to fasting glucose of \\<130mg/dL for 3 months","deathsNumAffected":1,"deathsNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":0,"otherNumAtRisk":10},{"id":"EG002","title":"Liraglutide Plus Insulin Detemir","description":"Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.\n\nliraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \\<130mg/dL for 3 months.","deathsNumAffected":0,"deathsNumAtRisk":11,"seriousNumAffected":0,"seriousNumAtRisk":11,"otherNumAffected":2,"otherNumAtRisk":11}],"seriousEvents":[{"term":"Gastrointestinal intolerance","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":11}]}],"otherEvents":[{"term":"Gastrointestinal intolerance","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":11}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Kieren J. Mather MD","organization":"Indiana University","email":"kmather@iu.edu","phone":"317-278-7826"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2010-10-29","uploadDate":"2019-05-31T09:00","filename":"Prot_SAP_000.pdf","size":564335}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"},{"id":"D003920","term":"Diabetes Mellitus"}],"ancestors":[{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069450","term":"Liraglutide"},{"id":"D000069057","term":"Insulin Detemir"}],"ancestors":[{"id":"D052216","term":"Glucagon-Like Peptide 1"},{"id":"D004763","term":"Glucagon-Like Peptides"},{"id":"D052336","term":"Proglucagon"},{"id":"D005768","term":"Gastrointestinal Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"},{"id":"D049528","term":"Insulin, Long-Acting"},{"id":"D061385","term":"Insulins"},{"id":"D010187","term":"Pancreatic Hormones"},{"id":"D036361","term":"Peptide Hormones"},{"id":"D010455","term":"Peptides"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"}]}},"hasResults":true}