{"protocolSection":{"identificationModule":{"nctId":"NCT00516074","orgStudyIdInfo":{"id":"H8O-MC-GWCD"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes","officialTitle":"A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-09"},"primaryCompletionDateStruct":{"date":"2008-04","type":"ACTUAL"},"completionDateStruct":{"date":"2008-04","type":"ACTUAL"},"studyFirstSubmitDate":"2007-08-10","studyFirstSubmitQcDate":"2007-08-10","studyFirstPostDateStruct":{"date":"2007-08-14","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-04-24","resultsFirstSubmitQcDate":"2009-04-24","resultsFirstPostDateStruct":{"date":"2009-06-12","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-03-19","lastUpdatePostDateStruct":{"date":"2015-04-07","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study will explore the effect of exenatide (given twice a day) versus placebo (given twice a day) treatment on change in mean 24-hour heart rate over a 12 week period of drug exposure in patients with type 2 diabetes."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["exenatide","Byetta","type 2 diabetes","heart rate","Amylin","Lilly"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":54,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide Arm","type":"EXPERIMENTAL","description":"This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study.","interventionNames":["Drug: exenatide"]},{"label":"Placebo Arm","type":"PLACEBO_COMPARATOR","description":"This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm).","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"exenatide","description":"subcutaneous injection, 5mcg or 10mcg, twice a day","armGroupLabels":["Exenatide Arm"],"otherNames":["Byetta","AC2993","LY2148568"]},{"type":"DRUG","name":"placebo","description":"subcutaneous injection, volume equivalent to active, twice a day","armGroupLabels":["Placebo Arm"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Mean 24-hour Heart Rate From Baseline to Endpoint","description":"Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.","timeFrame":"12 weeks"}],"secondaryOutcomes":[{"measure":"Change in Daytime Heart Rate From Baseline to Endpoint","description":"Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor","timeFrame":"12 weeks"},{"measure":"Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint","description":"Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor","timeFrame":"12 weeks"},{"measure":"Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint","description":"Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor","timeFrame":"12 weeks"},{"measure":"Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint","description":"Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor","timeFrame":"12 weeks"},{"measure":"Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint","description":"Change from baseline to endpoint in HbA1c","timeFrame":"12 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes.\n* Treated with metformin and/or a thiazolidinedione.\n* HbA1c between 6.5% and 9.5%, inclusive.\n* Body Mass Index (BMI) \\> 25 kg/m\\^2 and \\< 40 kg/m\\^2.\n\nExclusion Criteria:\n\n* Have previously received exenatide or glucagon-like peptide-1 analogs.\n* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.\n* Receiving beta blockers.\n* Receiving treatment with a drug directly affecting gastrointestinal motility, including but not limited to Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.\n* Have received treatment with systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route within 6 weeks of screening, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption or bronchodilators.\n* Have been treated with drugs that promote weight loss (for example, Adipex® \\[phentermine\\], Acomplia® \\[rimonabant\\], Xenical® \\[orlistat\\], Meridia® \\[sibutramine\\], Acutrim® \\[phenylpropanolamine\\], or similar over-the-counter medications) within 3 months of screening.\n* Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: \\*Insulin; \\*Alpha-glucosidase inhibitors (for example, Glyset® \\[miglitol\\] or Precose® \\[acarbose\\]); \\*Meglitinides (for example, Prandin® \\[repaglinide\\] or Starlix® \\[nateglinide\\]); \\*Sulfonylureas (for example, Glucotrol® \\[glipizide\\] or Micronase® \\[glyburide\\]); \\*Dipeptidyl peptidase IV (DPP-IV) inhibitors (for example, Januvia™ \\[sitagliptin\\])\n* Have donated blood within 60 days of screening.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Chief Medical Officer, MD","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Research Site","city":"Halifax","state":"Nova Scotia","country":"Canada","geoPoint":{"lat":44.64269,"lon":-63.57688}},{"facility":"Research Site","city":"Toronto","state":"Ontario","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Research Site","city":"Etten-Leur","country":"Netherlands","geoPoint":{"lat":51.57056,"lon":4.63726}},{"facility":"Research Site","city":"Leiden","country":"Netherlands","geoPoint":{"lat":52.15833,"lon":4.49306}},{"facility":"Research Site","city":"Rotterdam","country":"Netherlands","geoPoint":{"lat":51.9225,"lon":4.47917}},{"facility":"Research Site","city":"Utrecht","country":"Netherlands","geoPoint":{"lat":52.09083,"lon":5.12222}}]},"referencesModule":{"references":[{"pmid":"20109208","type":"DERIVED","citation":"Gill A, Hoogwerf BJ, Burger J, Bruce S, Macconell L, Yan P, Braun D, Giaconia J, Malone J. Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study. Cardiovasc Diabetol. 2010 Jan 28;9:6. doi: 10.1186/1475-2840-9-6."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide BID","description":"5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study."},{"id":"FG001","title":"Placebo","description":"Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"26"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"23"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Subject Decision","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Loss of Glucose Control","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide BID","description":"5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study."},{"id":"BG001","title":"Placebo","description":"Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm)."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"54"}]}],"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"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"46"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56.62","spread":"10.90"},{"groupId":"BG001","value":"54.14","spread":"10.13"},{"groupId":"BG002","value":"55.43","spread":"10.51"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"24"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"30"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Mean 24-hour Heart Rate From Baseline to Endpoint","description":"Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.","populationDescription":"Intent to treat; Last observation carried forward","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"beats per minute","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Exenatide BID","description":"5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study."},{"id":"OG001","title":"Placebo","description":"Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"Baseline (Week 0)","categories":[{"measurements":[{"groupId":"OG000","value":"74.83","spread":"2.04"},{"groupId":"OG001","value":"74.47","spread":"2.08"}]}]},{"title":"Change at endpoint (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"2.14","spread":"1.39"},{"groupId":"OG001","value":"-0.71","spread":"1.42"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Approximately 25 subjects were intended to be randomized to both the exenatide and placebo arms. Assuming an approximate 24% dropout rate, 19 patients per treatment arm would complete the study. A sample of 19 patients per treatment group would provide 90% power to detect a 10 bpm difference between treatment groups in change in daily mean heart rate from baseline.","pValue":"0.1585","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Daytime Heart Rate From Baseline to Endpoint","description":"Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor","populationDescription":"Intent to treat; Last observation carried forward","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"beats per minute","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Exenatide BID","description":"5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study."},{"id":"OG001","title":"Placebo","description":"Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"Baseline (Week 0)","categories":[{"measurements":[{"groupId":"OG000","value":"75.97","spread":"2.22"},{"groupId":"OG001","value":"75.37","spread":"2.26"}]}]},{"title":"Change at endpoint (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"2.35","spread":"1.59"},{"groupId":"OG001","value":"-0.87","spread":"1.62"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Power calculation for the primary endpoint is described as part of the primary endpoint information above.","pValue":"0.1624","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint","description":"Change from baseline to endpoint in nighttime (2400-0600) heart rate 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12)","categories":[{"measurements":[{"groupId":"OG000","value":"1.43","spread":"1.79"},{"groupId":"OG001","value":"-0.28","spread":"1.83"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Power calculation for the primary endpoint is described as part of the primary endpoint information above.","pValue":"0.5077","statisticalMethod":"ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint","description":"Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor","populationDescription":"Intent to treat; Last observation carried forward","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Exenatide BID","description":"5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study."},{"id":"OG001","title":"Placebo","description":"Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"Baseline (Week 0)","categories":[{"measurements":[{"groupId":"OG000","value":"126.61","spread":"3.04"},{"groupId":"OG001","value":"119.93","spread":"3.10"}]}]},{"title":"Change at endpoint (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.81","spread":"2.67"},{"groupId":"OG001","value":"-0.34","spread":"2.72"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Power calculation for the primary endpoint is described as part of the primary 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