{"protocolSection":{"identificationModule":{"nctId":"NCT02251431","orgStudyIdInfo":{"id":"014-149"},"secondaryIdInfos":[{"id":"D5551L00004/ISSEXEN0013","type":"OTHER_GRANT","domain":"AstraZeneca"}],"organization":{"fullName":"Baylor Research Institute","class":"OTHER"},"briefTitle":"Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome","officialTitle":"MB001-067 A PROSPECTIVE, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, RANDOMIZED TRIAL OF EXTENDED RELEASE EXENATIDE VERSUS PLACEBO (COHORT A) AND A PROSPECTIVE, SINGLE GROUP, OPEN-LABEL, BLINDED OUTCOME TRIAL OF EXTENDED RELEASE EXENATIDE (COHORT B) IN DIABETIC PATIENTS WITH TYPE 4 CARDIORENAL SYNDROME (EXTEND-CRS TRIAL) AMENDMENT 3"},"statusModule":{"statusVerifiedDate":"2020-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-11","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-12","type":"ACTUAL"},"completionDateStruct":{"date":"2019-12","type":"ACTUAL"},"studyFirstSubmitDate":"2014-09-12","studyFirstSubmitQcDate":"2014-09-25","studyFirstPostDateStruct":{"date":"2014-09-29","type":"ESTIMATED"},"resultsFirstSubmitDate":"2023-03-21","resultsFirstSubmitQcDate":"2023-04-24","resultsFirstPostDateStruct":{"date":"2023-05-17","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-02-04","lastUpdatePostDateStruct":{"date":"2026-02-19","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Baylor Research Institute","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Among adult individuals with type 2 diabetes mellitus and at risk for heart failure with impaired relaxation of the heart mildly reduced kidney filtration function (Type 4 cardiorenal syndrome) this trial will evaluate the quantitative impact of 38 weeks of treatment with exenatide extended-release injections versus placebo. on a cardiac biomarker blood test score, cardiac fibrosis seen on magnetic resonance scanning, cardiac strain identified by ultrasonography and strain rate imaging, and a kidney urine biomarker score.","detailedDescription":"Primary Aim\n\nAmong adult individuals with type 2 diabetes mellitus (T2DM) and at risk for diastolic heart failure (DHF) and mildly reduced renal filtration function (Type 4 cardiorenal syndrome), to evaluate the quantitative impact on the MISS (myocardial injury summary score) cardiac biomarker score, cardiac fibrosis by MRI, cardiac strain by ultrasonography and strain rate imaging, and KISS (kidney injury summary score) kidney biomarker score after 38 weeks of treatment with exenatide extended-release or placebo.\n\nSecondary Aim\n\nTo evaluate the inter-relationships between demographic, clinical, and biochemical variables (MISS score, KISS score) and of progressive cardiac fibrosis as assessed by MRI, strain-rate imaging, and in adult individuals with T2DM and at risk for DHF (Type 4 cardiorenal syndrome)."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus","Chronic Kidney Disease","Left Ventricular Diastolic Dysfunction"],"keywords":["diabetes mellitus","chronic kidney disease","diastolic function","cardiac fibrosis","cardiac strain","cardiac biomarker","renal biomarker"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":57,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide-extended release","type":"EXPERIMENTAL","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks","interventionNames":["Drug: BYDUREON"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Matching placebo subcutaneously once per week x 38 weeks","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"BYDUREON","description":"Exenatide-extended release, Cohorts A and B","armGroupLabels":["Exenatide-extended release"]},{"type":"DRUG","name":"Placebo","description":"Cohort A only","armGroupLabels":["Placebo"],"otherNames":["Matching placebo subcutaneous injection"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Galectin-3","description":"Mean change in plasma galectin-3 (pg/ml)","timeFrame":"38 weeks"},{"measure":"ST2","description":"Mean change in plasma ST2 (pg/ml)","timeFrame":"38 weeks"},{"measure":"NGAL","description":"Mean change in urine neutrophil gelatinase associated lipocalin (NGAL):creatinine (Cr) ratio","timeFrame":"38 weeks"},{"measure":"KIM-1","description":"Mean change in urine kidney injury molecule-1 (KIM-1):Cr ratio","timeFrame":"38 weeks"},{"measure":"L-FABP","description":"Mean change in urine L-type fatty acid binding protein:Cr ratio","timeFrame":"38 weeks"},{"measure":"IL-18","description":"Mean change in urine interleukin-18:Cr ratio","timeFrame":"38 weeks"},{"measure":"Alpha GST","description":"Mean change in urine alpha glutathione S-transferase (αGST):Cr ratio","timeFrame":"38 weeks"},{"measure":"Troponin I","description":"Mean change in plasma ultrasensitive troponin I (pg/ml)","timeFrame":"38 weeks"},{"measure":"Pi GST","description":"Mean change in pi glutathione S-transferase (piGST):Cr ratio","timeFrame":"38 weeks"},{"measure":"NAG","description":"Mean change in urine N-acetyl-β-D-glucosaminidase (NAG):Cr ratio","timeFrame":"38 weeks"},{"measure":"Cystatin-C","description":"Mean paired change in urine cystatin-C:Cr ratio (uCysC:Cr)","timeFrame":"38 weeks"},{"measure":"BNP","description":"Mean change in plasma B-type natriuretic peptide BNP (pg/ml)","timeFrame":"38 weeks"},{"measure":"ACR","description":"Mean change in urine albumin:Cr ratio (ACR)","timeFrame":"38 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age ≥ 18\n* Type 2 diabetes mellitus with hemoglobin A1C 6.6-9.9% with or without the use of insulin\n* Estimated glomerular filtration rate (eGFR) between 50 and 90 ml/min/1.73 m2\n\nExclusion Criteria:\n\n* Allergy or intolerance to gadolinium\n* Implanted cardiac pacemaker, defibrillator, loop recorder, or other implanted metallic device\n* Any other metallic implanted device that is a contra-indication to MRI scanning\n* eGFR \\< 50 ml/min/1.73 m2\n* eGFR \\> 90 ml/min/1.73 m2\n* Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA™ (exenatide), BYDUREON™ (Exenatide extended-release), VICTOZA™ (liraglutide), or taspoglutide\n* Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.\n* Disorders of iron metabolism\n* Collagen vascular diseases\n* Myocardial infarction\n* Use of DDP4 inhibitors, and PPAR gamma agonists\n* Pregnancy or planned pregnancy during the trial period\n* Hemoglobin A1C of ≥ 10.0% or \\<6.6%\n* Fasting glucose ≥ 260 mg/dl\n* Clinically significant abnormal baseline laboratories\n* Morbid obesity or body girth that prohibits the ability to undergo echocardiography or MRI scanning with high-quality image results\n* Renal transplantation\n* Severe gastrointestinal, liver, or neurodegenerative disease\n* Decompensated liver cirrhosis (Child-Pugh score \\>7)\n* New York Heart Association Class III or IV heart failure\n* Patients have alanine aminotransaminase (ALT) greater than 5 times the upper limit of the reference range.\n* Prior pancreatitis\n* Personal or family history of medullary thyroid adenoma or carcinoma (MTC)\n* Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).\n* History of severe hypoglycemia\n* Prior bariatric surgery","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Peter A McCullough, MD, MPH","affiliation":"Baylor Research Institute","role":"STUDY_CHAIR"}],"locations":[{"facility":"Baylor Scott and White Research Institute- Baylor Heart and Vascular Hospital","city":"Dallas","state":"Texas","zip":"75226","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}}]},"referencesModule":{"references":[{"pmid":"17239676","type":"BACKGROUND","citation":"Chinnaiyan KM, Alexander D, Maddens M, McCullough PA. Curriculum in cardiology: integrated diagnosis and management of diastolic heart failure. Am Heart J. 2007 Feb;153(2):189-200. doi: 10.1016/j.ahj.2006.10.022."},{"pmid":"21802579","type":"BACKGROUND","citation":"Davidson MH. Cardiovascular effects of glucagonlike peptide-1 agonists. Am J Cardiol. 2011 Aug 2;108(3 Suppl):33B-41B. doi: 10.1016/j.amjcard.2011.03.046."},{"pmid":"1080957","type":"BACKGROUND","citation":"Levine GD, Rosai J, Bearman RM, Polliack A. The fine structure of thymoma, with emphasis on its differential diagnosis. A study of ten cases. Am J Pathol. 1975 Oct;81(1):49-86."},{"pmid":"20929995","type":"BACKGROUND","citation":"Best JH, Hoogwerf BJ, Herman WH, Pelletier EM, Smith DB, Wenten M, Hussein MA. Risk of cardiovascular disease events in patients with type 2 diabetes prescribed the glucagon-like peptide 1 (GLP-1) receptor agonist exenatide twice daily or other glucose-lowering therapies: a retrospective analysis of the LifeLink database. Diabetes Care. 2011 Jan;34(1):90-5. doi: 10.2337/dc10-1393. Epub 2010 Oct 7."},{"pmid":"22249510","type":"BACKGROUND","citation":"McCullough PA, Olobatoke A, Vanhecke TE. Galectin-3: a novel blood test for the evaluation and management of patients with heart failure. Rev Cardiovasc Med. 2011;12(4):200-10. doi: 10.3909/ricm0624."},{"pmid":"23482076","type":"BACKGROUND","citation":"Wang YC, Yu CC, Chiu FC, Tsai CT, Lai LP, Hwang JJ, Lin JL. Soluble ST2 as a biomarker for detecting stable heart failure with a normal ejection fraction in hypertensive patients. J Card Fail. 2013 Mar;19(3):163-8. doi: 10.1016/j.cardfail.2013.01.010."},{"pmid":"20620723","type":"BACKGROUND","citation":"Jellis C, Martin J, Narula J, Marwick TH. Assessment of nonischemic myocardial fibrosis. J Am Coll Cardiol. 2010 Jul 6;56(2):89-97. doi: 10.1016/j.jacc.2010.02.047."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"FG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"28"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"28"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"A total of 57 patients were enrolled from November 2015 to December 2019. Despite original plan of enrolling 104 patients, the recruitment stopped early due to poor accrual","groups":[{"id":"BG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"BG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"57"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57.78","spread":"12.83"},{"groupId":"BG001","value":"55.17","spread":"9.64"},{"groupId":"BG002","value":"56.50","spread":"11.35"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"33"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"24"}]}]}]},{"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"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African 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(pg/ml)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/ml","timeFrame":"38 weeks","groups":[{"id":"OG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"9570.91","spread":"4990.06"},{"groupId":"OG001","value":"9266.7","spread":"6032.8"}]}]},{"title":"End of study (38th week)","categories":[{"measurements":[{"groupId":"OG000","value":"9539.21","spread":"3893.04"},{"groupId":"OG001","value":"8098.78","spread":"6272.55"}]}]}]},{"type":"PRIMARY","title":"ST2","description":"Mean change in plasma ST2 (pg/ml)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/ml","timeFrame":"38 weeks","groups":[{"id":"OG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"635.2","spread":"449.82"},{"groupId":"OG001","value":"443.18","spread":"380.34"}]}]},{"title":"End of study (38th week)","categories":[{"measurements":[{"groupId":"OG000","value":"524.68","spread":"423.61"},{"groupId":"OG001","value":"534.53","spread":"302.89"}]}]}]},{"type":"PRIMARY","title":"NGAL","description":"Mean change in urine neutrophil gelatinase associated lipocalin (NGAL):creatinine (Cr) ratio","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mmol Creat","timeFrame":"38 weeks","groups":[{"id":"OG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"17.35","spread":"29.01"},{"groupId":"OG001","value":"18.44","spread":"25.01"}]}]},{"title":"End of study (38th week)","categories":[{"measurements":[{"groupId":"OG000","value":"14.01","spread":"14.87"},{"groupId":"OG001","value":"24.39","spread":"40.37"}]}]}]},{"type":"PRIMARY","title":"KIM-1","description":"Mean change in urine kidney injury molecule-1 (KIM-1):Cr ratio","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mmol Creat","timeFrame":"38 weeks","groups":[{"id":"OG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.08"},{"groupId":"OG001","value":"0.13","spread":"0.09"}]}]},{"title":"End of study (38th week)","categories":[{"measurements":[{"groupId":"OG000","value":"0.13","spread":"0.14"},{"groupId":"OG001","value":"0.1","spread":"0.05"}]}]}]},{"type":"PRIMARY","title":"L-FABP","description":"Mean change in urine L-type fatty acid binding protein:Cr ratio","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mmol Creat","timeFrame":"38 weeks","groups":[{"id":"OG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"2.61","spread":"3.72"},{"groupId":"OG001","value":"3.24","spread":"4.17"}]}]},{"title":"End of study (38th week)","categories":[{"measurements":[{"groupId":"OG000","value":"2.05","spread":"2.18"},{"groupId":"OG001","value":"3","spread":"2.85"}]}]}]},{"type":"PRIMARY","title":"IL-18","description":"Mean change in urine interleukin-18:Cr ratio","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/mmol Creat","timeFrame":"38 weeks","groups":[{"id":"OG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"1.68","spread":"2.4"},{"groupId":"OG001","value":"3.48","spread":"4.69"}]}]},{"title":"End of study (38th week)","categories":[{"measurements":[{"groupId":"OG000","value":"1.96","spread":"3.5"},{"groupId":"OG001","value":"2.68","spread":"2.48"}]}]}]},{"type":"PRIMARY","title":"Alpha GST","description":"Mean change in urine alpha glutathione S-transferase (αGST):Cr 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(pg/ml)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/ml","timeFrame":"38 weeks","groups":[{"id":"OG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"230.85","spread":"282.73"},{"groupId":"OG001","value":"415.65","spread":"446.33"}]}]},{"title":"End of study (38th week)","categories":[{"measurements":[{"groupId":"OG000","value":"238.53","spread":"283.59"},{"groupId":"OG001","value":"504.48","spread":"599.4"}]}]}]},{"type":"PRIMARY","title":"Pi GST","description":"Mean change in pi glutathione S-transferase (piGST):Cr ratio","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mmol Creat","timeFrame":"38 weeks","groups":[{"id":"OG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"3.41"},{"groupId":"OG001","value":"3.99","spread":"3.96"}]}]},{"title":"End of study (38th week)","categories":[{"measurements":[{"groupId":"OG000","value":"3.03","spread":"5.67"},{"groupId":"OG001","value":"4.27","spread":"4.67"}]}]}]},{"type":"PRIMARY","title":"NAG","description":"Mean change in urine N-acetyl-β-D-glucosaminidase (NAG):Cr ratio","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mmol Creat","timeFrame":"38 weeks","groups":[{"id":"OG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"17.35","spread":"29.01"},{"groupId":"OG001","value":"18.44","spread":"25.01"}]}]},{"title":"End of study (38th week)","categories":[{"measurements":[{"groupId":"OG000","value":"14.01","spread":"14.87"},{"groupId":"OG001","value":"24.39","spread":"40.37"}]}]}]},{"type":"PRIMARY","title":"Cystatin-C","description":"Mean paired change in urine cystatin-C:Cr ratio (uCysC:Cr)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mmol Creat","timeFrame":"38 weeks","groups":[{"id":"OG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"2.07","spread":"2.64"},{"groupId":"OG001","value":"1.84","spread":"1.19"}]}]},{"title":"End of study (38th week)","categories":[{"measurements":[{"groupId":"OG000","value":"1.47","spread":"1.22"},{"groupId":"OG001","value":"1.57","spread":"1.17"}]}]}]},{"type":"PRIMARY","title":"BNP","description":"Mean change in plasma B-type natriuretic peptide BNP (pg/ml)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/ml","timeFrame":"38 weeks","groups":[{"id":"OG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"4.87","spread":"9.3"},{"groupId":"OG001","value":"9.88","spread":"14.52"}]}]},{"title":"End of study (38th week)","categories":[{"measurements":[{"groupId":"OG000","value":"5.59","spread":"9.59"},{"groupId":"OG001","value":"14.02","spread":"22.53"}]}]}]},{"type":"PRIMARY","title":"ACR","description":"Mean change in urine albumin:Cr ratio (ACR)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mmol Creat","timeFrame":"38 weeks","groups":[{"id":"OG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"6678.23","spread":"12662.79"},{"groupId":"OG001","value":"9713.65","spread":"14380.38"}]}]},{"title":"End of study (38th week)","categories":[{"measurements":[{"groupId":"OG000","value":"3963.49","spread":"3101.13"},{"groupId":"OG001","value":"9825.2","spread":"9539.34"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"38 weeks from study initiation","eventGroups":[{"id":"EG000","title":"Exenatide-extended Release","description":"Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks","deathsNumAffected":0,"deathsNumAtRisk":29,"seriousNumAffected":0,"seriousNumAtRisk":29,"otherNumAffected":20,"otherNumAtRisk":29},{"id":"EG001","title":"Placebo","description":"Matching placebo subcutaneously once per week x 38 weeks","deathsNumAffected":0,"deathsNumAtRisk":28,"seriousNumAffected":1,"seriousNumAtRisk":28,"otherNumAffected":21,"otherNumAtRisk":28}],"seriousEvents":[{"term":"NSTEMI (non ST elevated myocardial infarction)","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":28}]}],"otherEvents":[{"term":"Injection site reaction","organSystem":"General 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Hence, null findings may be a result of lack of statistical power. Accordingly, our results should be interpreted as hypothesis-generating."},"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"LTE60","restrictiveAgreement":true},"pointOfContact":{"title":"Biostatistician","organization":"Baylor Scott & White Research Institute","email":"gelareh.rahimighazikalayeh@bswhealth.org","phone":"8033190755"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2019-02-26","uploadDate":"2021-11-24T15:17","filename":"Prot_SAP_000.pdf","size":524667}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"},{"id":"D051436","term":"Renal Insufficiency, Chronic"},{"id":"D018487","term":"Ventricular Dysfunction, Left"},{"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"},{"id":"D051437","term":"Renal Insufficiency"},{"id":"D007674","term":"Kidney Diseases"},{"id":"D014570","term":"Urologic Diseases"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D052801","term":"Male Urogenital Diseases"},{"id":"D002908","term":"Chronic Disease"},{"id":"D020969","term":"Disease Attributes"},{"id":"D010335","term":"Pathologic Processes"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D018754","term":"Ventricular Dysfunction"},{"id":"D006331","term":"Heart Diseases"},{"id":"D002318","term":"Cardiovascular 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}