{"protocolSection":{"identificationModule":{"nctId":"NCT04199728","orgStudyIdInfo":{"id":"13559"},"secondaryIdInfos":[{"id":"1UG3DA050325-01","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1UG3DA050325-01"}],"organization":{"fullName":"Milton S. Hershey Medical Center","class":"OTHER"},"briefTitle":"Use of a GLP-1R Agonist to Treat Opioid Use Disorder","officialTitle":"Use of a GLP-1R Agonist to Treat Opioid Use Disorder"},"statusModule":{"statusVerifiedDate":"2024-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-10-18","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-09-13","type":"ACTUAL"},"completionDateStruct":{"date":"2023-09-13","type":"ACTUAL"},"studyFirstSubmitDate":"2019-12-12","studyFirstSubmitQcDate":"2019-12-12","studyFirstPostDateStruct":{"date":"2019-12-16","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-09-13","resultsFirstSubmitQcDate":"2024-11-01","resultsFirstPostDateStruct":{"date":"2024-11-06","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-11-01","lastUpdatePostDateStruct":{"date":"2024-11-06","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Scott C Bunce, PhD","investigatorTitle":"Associate Professor of Psychiatry","investigatorAffiliation":"Milton S. Hershey Medical Center"},"leadSponsor":{"name":"Milton S. Hershey Medical Center","class":"OTHER"},"collaborators":[{"name":"National Institutes of Health (NIH)","class":"NIH"},{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"This research is being done to find out if liraglutide (brand name is Saxenda®) can safely and effectively reduce craving for opioids in patients with opioid use disorder, a primary factor contributing to early relapse.","detailedDescription":"The rationale for the proposed research is to develop an acute intervention that can improve treatment outcomes in opioid use disorder (OUD) by reducing craving, a primary factor contributing to early relapse. Although liraglutide was approved for human use in 2010, there are no data testing the effectiveness in patients with an OUD. The objective of the proposed research is to test whether treatment with a GLP-1R agonist can reduce craving in humans with OUD. Understanding how a 'satiety' agent may affect craving and brain responses to drug cues in an OUD population would provide entirely novel information. If liraglutide shows a trend towards efficacy, and safety of the GLP-1R agonist is demonstrated in this population, it would provide an indication to run the second phase, multi-center clinical trial of GLP-1R agonist in OUD patients."},"conditionsModule":{"conditions":["Opiate Substitution Treatment","Opioid-Related Disorders"],"keywords":["Opiate treatment","Opioid treatment","Glucagon-Like Peptide-1 Agonist","Opioid use disorder","Liraglutide"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1","PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":27,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Investigational group","type":"EXPERIMENTAL","description":"Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.","interventionNames":["Drug: Liraglutide Pen Injector"]},{"label":"Control group","type":"PLACEBO_COMPARATOR","description":"Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Liraglutide Pen Injector","description":"Liraglutide will be provided using an injection pen provided by the manufacturer","armGroupLabels":["Investigational group"],"otherNames":["Saxenda"]},{"type":"DRUG","name":"Placebo","description":"Placebo injection pen","armGroupLabels":["Control group"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS)","description":"Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving.","timeFrame":"Baseline (Day 1), End of the target drug dose (Day 19)"},{"measure":"Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)","description":"Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving.","timeFrame":"Baseline (Day 1), Treatment Days (Days 2-19)"}],"secondaryOutcomes":[{"measure":"Change in Blood Pressure","description":"Blood pressure measurements in mmHg. Both systolic and diastolic pressures will be assessed during the study period.","timeFrame":"Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)"},{"measure":"Change in Heart Rate","description":"Heart rate measurements in beats per minute.","timeFrame":"Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)"},{"measure":"Change in Respiratory Rate","description":"Respiratory rate in breaths per minute.","timeFrame":"Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)"},{"measure":"Absolute Change in Body Weight","description":"Body weight will be measured in kilograms (kg).","timeFrame":"From Day 1 to Day 19"},{"measure":"Percent Change in Body Weight","description":"Body weight will be measured in kilograms (kg) and change will measured in %.","timeFrame":"From Day 1 to Day 19"},{"measure":"Change in Fasting Blood Samples for Fructosamine","description":"Fructosamine is measured in umol/L","timeFrame":"From Day 2 to Day 19"},{"measure":"Change in Fasting Blood Samples for HA1c","description":"HA1c is measured in %","timeFrame":"From Day 2 to Day 19"},{"measure":"Frequency of Adverse Events (AE) and Serious Adverse Events (SAE)","description":"Number of participants affected by probable drug-related adverse events.","timeFrame":"Days 1-21 and at 30 days post-intervention (Day 49)."}],"otherOutcomes":[{"measure":"Change in Blood Oxygenation Level Response to Visual Opioid Drug Cues in Prefrontal Cortex Using Functional Near Infrared Spectroscopy (fNIRs)","description":"fNIRs indexes regional cerebral oxygenation saturation (%) by optical density (OD). Increased OD indicates increased blood oxygen saturation.","timeFrame":"Baseline (Day 1), end of the target drug dose (Day 19)"},{"measure":"Rebound Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)","description":"Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving. Treatment score is the average scores across Days 2-19. Rebound follow up score is the average scores across Days 20-21.","timeFrame":"Treatment (averaged across Days 2-19), Rebound follow up (averaged across Days 20-21)"},{"measure":"Rebound Change in Blood Pressure","description":"Blood pressure measurements in mmHg. Both pressures will be assessed during the study period.","timeFrame":"From end of the target drug dose (Day 19) to rebound follow up (Day 21)."},{"measure":"Rebound Change in Heart Rate","description":"Heart rate measurements in beats per minute","timeFrame":"From end of the target drug dose (Day 19) to rebound follow up (Day 21)."},{"measure":"Rebound Change in Respiratory Rate","description":"Respiratory rate in breaths per minutes.","timeFrame":"From end of the target drug dose (Day 19) to rebound follow up (Day 21)."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age 18 to 75 years\n* Diagnosed with an OUD seeking treatment at Caron Treatment Centers (CaronTC) and planning on being enrolled in a residential treatment plan for a minimum of 4 weeks\n* Women of childbearing potential must consent to use a medically accepted method of birth control or to abstain from sexual intercourse while in the study\n* Able and willing to provide informed consent prior to any study-related activities\n* Must be able to read and communicate in English sufficiently to complete all study requirements, including Ecology Momentary Assessment (EMA)\n\nExclusion Criteria:\n\n* Age \\< 18 or \\> 75 years\n* Women who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures\n* History of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to liraglutide or another glucagon-like peptide-1 receptor (GLP1R) agonist\n* Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2) or thyroid nodule\n* Type I diabetes or history of diabetic ketoacidosis\n* Type II diabetes mellitus\n* Hypoglycemia on intake visit (blood glucose \\< 70 mg/dL)\n* End-stage renal failure on dialysis or glomerular filtration rate (GFR) \\<30 mL/min per 1.73 square meters or previous renal transplant\n* Severe hepatic impairment (AST or ALT levels \\> 3 times upper limit of normal range) or previous liver transplant\n* Current or past diagnosis of pancreatitis, gastroparesis, or other severe gastrointestinal disease\n* Current or past diagnosis of gallbladder disease or gallstones\n* Serious cardiovascular disease within the past 6 months (e.g. uncontrolled hypertension, heart failure, significant cardiac arrhythmias, myocardial infarction, presence of angina pectoris, symptomatic coronary artery disease, deep vein thrombosis, pulmonary embolism, second- or third-degree heart block, mitral valve or aortic stenosis, hypertrophic cardiomyopathy, stroke)\n* Severe co-occurring psychiatric disorder (e.g., bipolar disorder, psychotic disorder, schizophrenia) that would, in the opinion of the Principle Investigator or study physician, interfere with participating in the study, such as if the patient needs a higher or different level of care and is going to be transferred out of Caron.\n* Suicidal ideation within the past 1 month, or history of suicide attempts within the past 1 year, unless participation is cleared by clinician assessment and/or judgement.\n* Treatment with any investigational drug in the one-month preceding the study\n* Previous randomization for participation in this trial\n* Abnormal physical exam findings, vital signs (blood pressure, heart rate, respiratory rate, body temperature), EKG measurements, and safety lab values that are deemed clinically significant by study physician","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Scott Bunce, PhD","affiliation":"Milton S. Hershey Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Penn State Milton S Hershey Medical Center","city":"Hershey","state":"Pennsylvania","zip":"17033","country":"United States","geoPoint":{"lat":40.28592,"lon":-76.65025}}]},"referencesModule":{"references":[{"pmid":"39061093","type":"DERIVED","citation":"Freet CS, Evans B, Brick TR, Deneke E, Wasserman EJ, Ballard SM, Stankoski DM, Kong L, Raja-Khan N, Nyland JE, Arnold AC, Krishnamurthy VB, Fernandez-Mendoza J, Cleveland HH, Scioli AD, Molchanow A, Messner AE, Ayaz H, Grigson PS, Bunce SC. Ecological momentary assessment and cue-elicited drug craving as primary endpoints: study protocol for a randomized, double-blind, placebo-controlled clinical trial testing the efficacy of a GLP-1 receptor agonist in opioid use disorder. Addict Sci Clin Pract. 2024 Jul 27;19(1):56. doi: 10.1186/s13722-024-00481-7."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Two participants were not randomized due to screening after consent and prior to randomization.","recruitmentDetails":"Protocol was approved for a 3-dose intervention that could continue as a 5-dose intervention; no participants received the latter. All outcomes are reported as the 3-dose intervention.","groups":[{"id":"FG000","title":"Investigational Group","description":"Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.\n\nLiraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer"},{"id":"FG001","title":"Control Group","description":"Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.\n\nPlacebo: Placebo injection pen"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"13"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Screen fail after consent","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Early withdraw criteria met","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Non-compliance/difficulty with staff","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Randomized participants in residential treatment for opioid use disorder","groups":[{"id":"BG000","title":"Investigational Group","description":"Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.\n\nLiraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer"},{"id":"BG001","title":"Control Group","description":"Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.\n\nPlacebo: Placebo injection pen"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"25"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"35.23","spread":"2.04"},{"groupId":"BG001","value":"32.03","spread":"2.19"},{"groupId":"BG002","value":"33.57","spread":"1.51"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"21"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"24"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]}]},{"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 American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"22"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS)","description":"Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving.","populationDescription":"In control group, n=1 did not complete the measure due to technical difficulties. n=7 instead of n=8 reported.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline (Day 1), End of the target drug dose (Day 19)","groups":[{"id":"OG000","title":"Investigational Group","description":"Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.\n\nLiraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer"},{"id":"OG001","title":"Control Group","description":"Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.\n\nPlacebo: Placebo injection pen"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.00","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"-13.34","spread":"19.58"}]}]}]},{"type":"PRIMARY","title":"Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)","description":"Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving.","populationDescription":"n=1 did not complete entire EMA. n=7 instead of n=8 reported.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline (Day 1), Treatment Days (Days 2-19)","groups":[{"id":"OG000","title":"Investigational Group","description":"Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.\n\nLiraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer"},{"id":"OG001","title":"Control Group","description":"Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.\n\nPlacebo: Placebo injection pen"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.55","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"-1.41","spread":"0.99"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure","description":"Blood pressure measurements in mmHg. Both systolic and diastolic pressures will be assessed during the study period.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)","groups":[{"id":"OG000","title":"Investigational Group","description":"Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.\n\nLiraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer"},{"id":"OG001","title":"Control Group","description":"Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.\n\nPlacebo: Placebo injection pen"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"8"}]}],"classes":[{"title":"Systolic Pressure, from Day 2","categories":[{"measurements":[{"groupId":"OG000","value":"4.00","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"-0.59","spread":"4.69"}]}]},{"title":"Systolic Pressure, from Day 8","categories":[{"measurements":[{"groupId":"OG000","value":"9.00","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"2.75","spread":"6.67"}]}]},{"title":"Systolic Pressure, from Day 14","categories":[{"measurements":[{"groupId":"OG000","value":"3.75","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"2.13","spread":"8.13"}]}]},{"title":"Diastolic Pressure, from Day 2","categories":[{"measurements":[{"groupId":"OG000","value":"3.00","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"2.56","spread":"6.17"}]}]},{"title":"Diastolic Pressure, from Day 8","categories":[{"measurements":[{"groupId":"OG000","value":"2.25","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"3.34","spread":"6.61"}]}]},{"title":"Diastolic Pressure, from Day 14","categories":[{"measurements":[{"groupId":"OG000","value":"2.75","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"4.19","spread":"7.51"}]}]}]},{"type":"SECONDARY","title":"Change in Heart Rate","description":"Heart rate measurements in beats per minute.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats per minute","timeFrame":"Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)","groups":[{"id":"OG000","title":"Investigational Group","description":"Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.\n\nLiraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer"},{"id":"OG001","title":"Control Group","description":"Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.\n\nPlacebo: Placebo injection pen"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"8"}]}],"classes":[{"title":"Day 02 change from baseline","categories":[{"measurements":[{"groupId":"OG000","value":"10.75","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"-5.78","spread":"5.10"}]}]},{"title":"Day 08 change from baseline","categories":[{"measurements":[{"groupId":"OG000","value":"20.00","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"-2.63","spread":"10.98"}]}]},{"title":"Day 14 change from baseline","categories":[{"measurements":[{"groupId":"OG000","value":"9.75","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"-3.09","spread":"11.20"}]}]}]},{"type":"SECONDARY","title":"Change in Respiratory Rate","description":"Respiratory rate in breaths per minute.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"breaths per minute","timeFrame":"Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)","groups":[{"id":"OG000","title":"Investigational Group","description":"Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.\n\nLiraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer"},{"id":"OG001","title":"Control Group","description":"Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.\n\nPlacebo: Placebo injection pen"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"8"}]}],"classes":[{"title":"Day 02 change from baseline","categories":[{"measurements":[{"groupId":"OG000","value":"-1.00","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"0.08","spread":"2.83"}]}]},{"title":"Day 08 change from baseline","categories":[{"measurements":[{"groupId":"OG000","value":"0.67","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"-1.08","spread":"2.74"}]}]},{"title":"Day 14 change from baseline","categories":[{"measurements":[{"groupId":"OG000","value":"1.33","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"-0.13","spread":"2.49"}]}]}]},{"type":"SECONDARY","title":"Absolute Change in Body Weight","description":"Body weight will be measured in kilograms (kg).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"From Day 1 to Day 19","groups":[{"id":"OG000","title":"Investigational Group","description":"Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.\n\nLiraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer"},{"id":"OG001","title":"Control Group","description":"Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.\n\nPlacebo: Placebo injection pen"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.27","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"1.05","spread":"1.86"}]}]}]},{"type":"SECONDARY","title":"Percent Change in Body Weight","description":"Body weight will be measured in kilograms (kg) and change will measured in %.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"% change","timeFrame":"From Day 1 to Day 19","groups":[{"id":"OG000","title":"Investigational Group","description":"Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.\n\nLiraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer"},{"id":"OG001","title":"Control Group","description":"Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.\n\nPlacebo: Placebo injection pen"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.33","spread":"NA","comment":"Standard Deviation is not calculable for 1 participant"},{"groupId":"OG001","value":"1.38","spread":"2.39"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Blood Samples for Fructosamine","description":"Fructosamine is measured in umol/L","populationDescription":"In control group, n=1 could not obtain blood draw for measure. n=7 instead of n=8 reported.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"umol/L","timeFrame":"From Day 2 to Day 19","groups":[{"id":"OG000","title":"Investigational Group","description":"Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. 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