{"protocolSection":{"identificationModule":{"nctId":"NCT01147627","orgStudyIdInfo":{"id":"IIT-201007-WJP"},"organization":{"fullName":"Sun Yat-sen University","class":"OTHER"},"briefTitle":"Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients","officialTitle":"Comparison of Exenatide, Insulin or Pioglitazone on Glycaemic Control and β-cell Function in Drug-naïve Type 2 Diabetic Patients: A Multicentre Randomized Parallel-group Trial"},"statusModule":{"statusVerifiedDate":"2013-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-08"},"primaryCompletionDateStruct":{"date":"2012-08","type":"ACTUAL"},"completionDateStruct":{"date":"2012-12","type":"ACTUAL"},"studyFirstSubmitDate":"2010-06-18","studyFirstSubmitQcDate":"2010-06-18","studyFirstPostDateStruct":{"date":"2010-06-22","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-06-06","resultsFirstSubmitQcDate":"2013-06-11","resultsFirstPostDateStruct":{"date":"2013-08-21","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-06-11","lastUpdatePostDateStruct":{"date":"2013-08-21","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Jianping Weng","investigatorTitle":"professor, vice president, the third affiliated hospital of Sun Yat-sen University","investigatorAffiliation":"Sun Yat-sen University"},"leadSponsor":{"name":"Sun Yat-sen University","class":"OTHER"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"},{"name":"Amylin Pharmaceuticals, LLC.","class":"INDUSTRY"},{"name":"Ministry of Health, China","class":"OTHER_GOV"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.","detailedDescription":"One of the fundamental defects in type 2 diabetes mellitus is declining β-cell function. Exenatide targets multiple metabolic disturbances in type 2 diabetes and exerts direct effects on β-cell, which indicates that it may not only contribute to the glucose control but also delay disease progression. There are trials demonstrated efficacy, safety and tolerability of exenatide. However, no study has compared the effects of exenatide with other hypoglycemic therapies with β cell protective function in newly diagnosed and drug-naïve type 2 diabetic patients. This current study is thus designed to evaluate the effects of exenatide, insulin and pioglitazone on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2","Newly Diagnosed"],"keywords":["diabetes mellitus, type 2","newly diagnosed","exenatide","premixed insulin analog","thiazolidinedione","β-cell function","glycemic control"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":416,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: exenatide injection"]},{"label":"Premixed insulin analog","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R"]},{"label":"pioglitazone","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Pioglitazone"]}],"interventions":[{"type":"DRUG","name":"exenatide injection","description":"Patients in exenatide group will be treated with exenatide (Byetta®, Eli Lilly and Company) 5 µg BID for the first 4 weeks and then 10 µg BID thereafter.","armGroupLabels":["Exenatide"],"otherNames":["Byetta®(Eli Lilly and Company)"]},{"type":"DRUG","name":"Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R","description":"Patients in insulin group will be treated with premixed insulin analog (Humalog Mix 25, Eli Lilly and Company). The initial insulin doses are 0.4 IU/kg per day(50% before breakfast and 50% before dinner). Insulin doses are titrated following a forced schedule according to blood glucose before breakfast and dinner.","armGroupLabels":["Premixed insulin analog"],"otherNames":["Humalog Mix 25®（Eli Lilly and Company)"]},{"type":"DRUG","name":"Pioglitazone","description":"Patients in thiazolidinedione group will be treated with Pioglitazone 30mg daily as single dose. The dose will be increased to 45mg daily after 4 weeks.","armGroupLabels":["pioglitazone"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks","timeFrame":"48 weeks"}],"secondaryOutcomes":[{"measure":"Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles","timeFrame":"48 weeks"},{"measure":"β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)","timeFrame":"48 weeks"},{"measure":"Safety and Tolerability in Different Groups","timeFrame":"48 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* newly-diagnosed type 2 diabetic patients, drug naïve\n* age 30\\~70 years\n* HbA1c 7.0\\~10.0%\n* BMI 20\\~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening\n* female patients of reproductive age should practice a reliable method of birth control throughout the study\n\nExclusion Criteria:\n\n* acute or severe chronic diabetic complications\n* congestive heart failure (NYHA grade Ⅲ\\~Ⅳ)\n* severe gastrointestinal disease\n* severe osteoporosis or history of pathological fracture,or use of bisphosphonates preparation\n* other severe intercurrent illness\n* serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)\n* tested positive for glutamic acid decarboxylase antibody\n* use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug\n* history of pancreatitis\n* serum triglyceride ≥ 5.0 mmol/L\n* pregnancy","healthyVolunteers":false,"sex":"ALL","minimumAge":"30 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jianping Weng, Doctor","affiliation":"Third Affiliated Hospital, Sun Yat-Sen University","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"China-Japan Friendship Hospital","city":"Beijing","state":"Beijing Municipality","zip":"100029","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Peking University People's Hospital","city":"Beijing","state":"Beijing Municipality","zip":"100044","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Beijing Hospital","city":"Beijing","state":"Beijing Municipality","zip":"100730","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Chinese PLA General Hospital","city":"Beijing","state":"Beijing Municipality","zip":"100853","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Peking University First Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"The Military General Hospital of Beijing PLA","city":"Beijing","state":"Beijing Municipality","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"The Second Affiliated Hospital of Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","zip":"510000","country":"China","geoPoint":{"lat":23.11667,"lon":113.25}},{"facility":"The Third Affiliated Hospital of Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","zip":"510630","country":"China","geoPoint":{"lat":23.11667,"lon":113.25}},{"facility":"Qingyuan People's hospital","city":"Qingyuan","state":"Guangdong","zip":"511500","country":"China","geoPoint":{"lat":23.7,"lon":113.03333}},{"facility":"The first Affiliated Hospital of Shantou University Medical College","city":"Shantou","state":"Guangdong","zip":"515041","country":"China","geoPoint":{"lat":23.35489,"lon":116.67876}},{"facility":"Shenzhen Second People's Hospital","city":"Shenzhen","state":"Guangdong","zip":"518035","country":"China","geoPoint":{"lat":22.54554,"lon":114.0683}},{"facility":"Affiliated hospital of Guangdong medical college","city":"Zhanjiang","state":"Guangdong","zip":"524001","country":"China","geoPoint":{"lat":21.23391,"lon":110.38749}},{"facility":"The first affiliated hospital of Guangxi Medical College","city":"Nanning","state":"Guangxi","zip":"530000","country":"China","geoPoint":{"lat":22.81667,"lon":108.31667}},{"facility":"The Affiliated Hospital of Guiyang Medical College","city":"Guiyang","state":"Guizhou","country":"China","geoPoint":{"lat":26.58333,"lon":106.71667}},{"facility":"The 2nd Affiliated Hospital of Harbin Medical University","city":"Harbin","state":"Heilongjiang","country":"China","geoPoint":{"lat":45.75,"lon":126.65}},{"facility":"Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology","city":"Wuhan","state":"Hubei","country":"China","geoPoint":{"lat":30.58333,"lon":114.26667}},{"facility":"Second Xiangya Hospital of Central-south University","city":"Changsha","state":"Hunan","zip":"410011","country":"China","geoPoint":{"lat":28.19874,"lon":112.97087}},{"facility":"The Affiliated Hospital of Inner Mangolia Medical College","city":"Hohhot","state":"Inner Mongolia","country":"China","geoPoint":{"lat":40.81056,"lon":111.65222}},{"facility":"Nanjing Drum Tower Hospital of Nanjing University Medical School","city":"Nanjing","state":"Jiangsu","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"The First Affiliated Hospital of Nanjing Medical University","city":"Nanjing","state":"Jiangsu","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"Zhongda Hospital of Southeast University","city":"Nanjing","state":"Jiangsu","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"China Medical University","city":"Shenyang","state":"Liaoning","zip":"110001","country":"China","geoPoint":{"lat":41.79222,"lon":123.43278}},{"facility":"Xijing Hospital of The Fourth Military Medical University","city":"Xi'an","state":"Shaanxi","country":"China","geoPoint":{"lat":34.25833,"lon":108.92861}},{"facility":"The First Affiliated Hospital of Kunming Medical College","city":"Kunming","state":"Yunnan","country":"China","geoPoint":{"lat":25.03889,"lon":102.71833}},{"facility":"The First Affiliated Hospital of Chongqing Medical University","city":"Chongqing","country":"China","geoPoint":{"lat":29.56026,"lon":106.55771}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide","description":"5 µg was injected twice-daily subcutaneously increasing to 10 µg twice-daily after 4 weeks. Those who experienced hypoglycaemia frequently or could not tolerate adverse events were instructed to reduce the dose to 5 µg twice-daily."},{"id":"FG001","title":"Premixed Insulin Analog","description":"Premixed insulin was injected twice-daily commencing with 0.4 IU/kg daily, with 50% given 15 minutes before breakfast and dinner respectively"},{"id":"FG002","title":"Pioglitazone","description":"Pioglitazone was commenced at a dose of 30 mg daily, increasing to 45 mg daily after 4 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"142"},{"groupId":"FG001","numSubjects":"138"},{"groupId":"FG002","numSubjects":"136"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"110"},{"groupId":"FG001","numSubjects":"114"},{"groupId":"FG002","numSubjects":"118"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"24"},{"groupId":"FG002","numSubjects":"18"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide"},{"id":"BG001","title":"Premixed Insulin Analog"},{"id":"BG002","title":"Thiazolidinedione"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"142"},{"groupId":"BG001","value":"138"},{"groupId":"BG002","value":"136"},{"groupId":"BG003","value":"416"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"128"},{"groupId":"BG002","value":"129"},{"groupId":"BG003","value":"389"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"27"}]}]}]},{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"49.89","spread":"9.64"},{"groupId":"BG001","value":"51.39","spread":"9.65"},{"groupId":"BG002","value":"49.66","spread":"8.86"},{"groupId":"BG003","value":"50.31","spread":"9.40"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"44"},{"groupId":"BG001","value":"53"},{"groupId":"BG002","value":"53"},{"groupId":"BG003","value":"150"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"98"},{"groupId":"BG001","value":"85"},{"groupId":"BG002","value":"83"},{"groupId":"BG003","value":"266"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"China","categories":[{"measurements":[{"groupId":"BG000","value":"142"},{"groupId":"BG001","value":"138"},{"groupId":"BG002","value":"136"},{"groupId":"BG003","value":"416"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of HbA1c","timeFrame":"48 weeks","groups":[{"id":"OG000","title":"Exenatide"},{"id":"OG001","title":"Premixed Insulin Analog"},{"id":"OG002","title":"Thiazolidinedione"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"110"},{"groupId":"OG001","value":"114"},{"groupId":"OG002","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"1.29"},{"groupId":"OG001","value":"-1.74","spread":"1.16"},{"groupId":"OG002","value":"-1.47","spread":"1.30"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"108 patients in each group was needed to provide 90% power to detect non-inferiority of exenatide, shown by a mean difference of 0.4% in HbA1c change from baseline.","pValue":"<0.05","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles","reportingStatus":"NOT_POSTED","timeFrame":"48 weeks"},{"type":"SECONDARY","title":"β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)","reportingStatus":"NOT_POSTED","timeFrame":"48 weeks"},{"type":"SECONDARY","title":"Safety and Tolerability in Different Groups","reportingStatus":"NOT_POSTED","timeFrame":"48 weeks"}]},"adverseEventsModule":{"frequencyThreshold":"1","eventGroups":[{"id":"EG000","title":"Exenatide","seriousNumAffected":5,"seriousNumAtRisk":142,"otherNumAffected":69,"otherNumAtRisk":142},{"id":"EG001","title":"Premixed Insulin Analog","seriousNumAffected":1,"seriousNumAtRisk":138,"otherNumAffected":42,"otherNumAtRisk":138},{"id":"EG002","title":"Thiazolidinedione","seriousNumAffected":7,"seriousNumAtRisk":136,"otherNumAffected":43,"otherNumAtRisk":136}],"seriousEvents":[{"term":"Cerebral infarction","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":0,"numAtRisk":136}]},{"term":"Cervical spondylosis","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":1,"numAtRisk":136}]},{"term":"Thigh myofascitis","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":0,"numAtRisk":136}]},{"term":"Acute pancreatitis","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":0,"numAtRisk":136}]},{"term":"Furuncle and secondary skin infection","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":1,"numAtRisk":136}]},{"term":"Acute nephritis","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":1,"numAtRisk":136}]},{"term":"Facial neuritis","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":1,"numAtRisk":136}]},{"term":"Linguinal herniation","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":1,"numAtRisk":136}]},{"term":"Pneumonia","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":1,"numAtRisk":136}]},{"term":"Cholangiocellular carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":0,"numAtRisk":136}]},{"term":"Proteinuria","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":0,"numAtRisk":136}]},{"term":"Cerebral infarction","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":142},{"groupId":"EG001","numAffected":1,"numAtRisk":138},{"groupId":"EG002","numAffected":0,"numAtRisk":136}]},{"term":"Cerebral infarction","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":1,"numAtRisk":136}]}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":142},{"groupId":"EG001","numAffected":1,"numAtRisk":138},{"groupId":"EG002","numAffected":1,"numAtRisk":136}]},{"term":"Vomitting","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":142},{"groupId":"EG001","numAffected":1,"numAtRisk":138},{"groupId":"EG002","numAffected":1,"numAtRisk":136}]},{"term":"abdominal pain","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":142},{"groupId":"EG001","numAffected":2,"numAtRisk":138},{"groupId":"EG002","numAffected":5,"numAtRisk":136}]},{"term":"diarrhea","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":142},{"groupId":"EG001","numAffected":1,"numAtRisk":138},{"groupId":"EG002","numAffected":4,"numAtRisk":136}]},{"term":"abdominal distention","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":1,"numAtRisk":136}]},{"term":"appetite loss","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":0,"numAtRisk":136}]},{"term":"constipation","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":1,"numAtRisk":136}]},{"term":"dizziness","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":142},{"groupId":"EG001","numAffected":7,"numAtRisk":138},{"groupId":"EG002","numAffected":4,"numAtRisk":136}]},{"term":"edema","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":12,"numAtRisk":136}]},{"term":"numbness","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":142},{"groupId":"EG001","numAffected":2,"numAtRisk":138},{"groupId":"EG002","numAffected":5,"numAtRisk":136}]},{"term":"fatigue","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":142},{"groupId":"EG001","numAffected":3,"numAtRisk":138},{"groupId":"EG002","numAffected":4,"numAtRisk":136}]},{"term":"injection site reaction","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":142},{"groupId":"EG001","numAffected":6,"numAtRisk":138},{"groupId":"EG002","numAffected":0,"numAtRisk":136}]},{"term":"palpitation","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":142},{"groupId":"EG001","numAffected":2,"numAtRisk":138},{"groupId":"EG002","numAffected":2,"numAtRisk":136}]},{"term":"headache","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":142},{"groupId":"EG001","numAffected":2,"numAtRisk":138},{"groupId":"EG002","numAffected":2,"numAtRisk":136}]},{"term":"upper respiratory tract infection","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":142},{"groupId":"EG001","numAffected":13,"numAtRisk":138},{"groupId":"EG002","numAffected":11,"numAtRisk":136}]},{"term":"blurred vision","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":142},{"groupId":"EG001","numAffected":1,"numAtRisk":138},{"groupId":"EG002","numAffected":3,"numAtRisk":136}]},{"term":"arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":142},{"groupId":"EG001","numAffected":1,"numAtRisk":138},{"groupId":"EG002","numAffected":4,"numAtRisk":136}]},{"term":"chest tightness","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":142},{"groupId":"EG001","numAffected":0,"numAtRisk":138},{"groupId":"EG002","numAffected":3,"numAtRisk":136}]},{"term":"rash","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":142},{"groupId":"EG001","numAffected":2,"numAtRisk":138},{"groupId":"EG002","numAffected":2,"numAtRisk":136}]},{"term":"skelalgia","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":142},{"groupId":"EG001","numAffected":1,"numAtRisk":138},{"groupId":"EG002","numAffected":1,"numAtRisk":136}]},{"term":"toothache","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":142},{"groupId":"EG001","numAffected":2,"numAtRisk":138},{"groupId":"EG002","numAffected":0,"numAtRisk":136}]},{"term":"allergy","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":142},{"groupId":"EG001","numAffected":1,"numAtRisk":138},{"groupId":"EG002","numAffected":0,"numAtRisk":136}]},{"term":"Weight gain","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":142},{"groupId":"EG001","numAffected":1,"numAtRisk":138},{"groupId":"EG002","numAffected":0,"numAtRisk":136}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"The open-label design, which could have introduced bias by affecting patients' expectations and adherence to therapy."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Jianping Weng","organization":"The Third Affiliated Hospital of Sun Yat-sen University","email":"wjianp@mail.sysu.edu.cn","phone":"86-20-85253162"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000077270","term":"Exenatide"},{"id":"D003132","term":"Commerce"},{"id":"D000077205","term":"Pioglitazone"}],"ancestors":[{"id":"D010455","term":"Peptides"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D014688","term":"Venoms"},{"id":"D045424","term":"Complex Mixtures"},{"id":"D014118","term":"Toxins, Biological"},{"id":"D001685","term":"Biological Factors"},{"id":"D013676","term":"Technology, Industry, and Agriculture"},{"id":"D045162","term":"Thiazolidinediones"},{"id":"D013844","term":"Thiazoles"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D001393","term":"Azoles"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}