{"protocolSection":{"identificationModule":{"nctId":"NCT02229383","orgStudyIdInfo":{"id":"D5553C00002"},"secondaryIdInfos":[{"id":"2014-003502-33","type":"EUDRACT_NUMBER"},{"id":"2014","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2014"}],"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus","officialTitle":"A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin"},"statusModule":{"statusVerifiedDate":"2018-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-09-06","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2016-08-29","type":"ACTUAL"},"completionDateStruct":{"date":"2016-08-29","type":"ACTUAL"},"studyFirstSubmitDate":"2014-08-28","studyFirstSubmitQcDate":"2014-08-28","studyFirstPostDateStruct":{"date":"2014-09-01","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-08-18","resultsFirstSubmitQcDate":"2017-08-18","resultsFirstPostDateStruct":{"date":"2017-09-18","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-12-17","lastUpdatePostDateStruct":{"date":"2019-01-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period."},"conditionsModule":{"conditions":["Diabetes Mellitus"],"keywords":["Diabetes Mellitus","Exenatide","Diabetes drug","Treatment efficacy","Placebo","Metabolism","Cardiovascilar metabolic"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":464,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide","type":"EXPERIMENTAL","description":"Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin","interventionNames":["Drug: Exenatide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin","interventionNames":["Drug: Exenatide matching placebo"]}],"interventions":[{"type":"DRUG","name":"Exenatide","description":"2 mg weekly suspension injection","armGroupLabels":["Exenatide"]},{"type":"DRUG","name":"Exenatide matching placebo","description":"Once weekly Placebo injection","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c From Baseline to Week 28","description":"To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.","timeFrame":"Baseline to Week 28"}],"secondaryOutcomes":[{"measure":"Change in Body Weight From Baseline to Week 28","description":"To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.","timeFrame":"Baseline to Week 28"},{"measure":"Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)","description":"To compare the change from baseline in 2-hour postprandial glucose after a standard MTT achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.","timeFrame":"Baseline to Week 28"},{"measure":"Percentage of Participants Achieving HbA1c <7.0% at Week 28","description":"To compare the percentage of participants achieving HbA1c \\<7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.","timeFrame":"Baseline to Week 28"},{"measure":"Change From Baseline to Week 28 in Daily Insulin Dose","description":"To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.","timeFrame":"Baseline to Week 28"},{"measure":"Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks","description":"To compare the percentage of participants achieving HbA1c \\<7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin.","timeFrame":"Baseline to Week 28"},{"measure":"Change in Seated Systolic Blood Pressure From Baseline to Week 28","description":"To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.","timeFrame":"Baseline to Week 28"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria:\n\n* Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)\n* Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).\n* Has fasting plasma glucose (FPG) concentration \\<280 mg/dL (15.6 mmol/L) at Visit 1 (Screening)\n* Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with:\n\n  1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1\n  2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit\n\nExclusion criteria:\n\n* Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)\n* History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1\n* Positive serological test for hepatitis B or hepatitis C","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"130 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Research Site","city":"Birmingham","state":"Alabama","zip":"35235","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Research Site","city":"Huntsville","state":"Alabama","zip":"35801","country":"United States","geoPoint":{"lat":34.7304,"lon":-86.58594}},{"facility":"Research Site","city":"Muscle 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Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18."},{"pmid":"29473704","type":"DERIVED","citation":"Guja C, Frias JP, Somogyi A, Jabbour S, Wang H, Hardy E, Rosenstock J. Effect of exenatide QW or placebo, both added to titrated insulin glargine, in uncontrolled type 2 diabetes: The DURATION-7 randomized study. Diabetes Obes Metab. 2018 Jul;20(7):1602-1614. doi: 10.1111/dom.13266. Epub 2018 Mar 25."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The study had a Screening Visit, an 8-week insulin dose optimization phase, followed by a 28-week randomized, double-blind treatment phase. A total of 464 participants were randomized and entered the double-blind Treatment Period. 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Study conclusions remain unchanged."},"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"At least 30 days prior to submission for publication or presentation, Authors shall provide Sponsor with such material for its review. Sponsor shall have 30 days to comment. If requested by Sponsor, Authors shall withhold material for an additional 90 days to allow for the taking of measures to establish its proprietary rights. No publication or presentation shall be made unless and until any information determined at Sponsor's sole discretion to be Confidential has been removed."},"pointOfContact":{"title":"Global Clinical Leader","organization":"AstraZeneca","email":"ClinicalTrialTransparency@astrazeneca.com","phone":"+1 302 885 1180"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"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":"D000077270","term":"Exenatide"}],"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"}]}},"hasResults":true}