{"protocolSection":{"identificationModule":{"nctId":"NCT01966978","orgStudyIdInfo":{"id":"STU 072013-030"},"organization":{"fullName":"University of Texas Southwestern Medical Center","class":"OTHER"},"briefTitle":"The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study","officialTitle":"The Effect of Simple Insulin Detemir Titration, Metformin Plus Liraglutide Compared to Simple Insulin Detemir Titration Plus Insulin Aspart and Metformin for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study: A 26 Week, Randomized, Open Label, Parallel-group, Intention to Treat Study","acronym":"SIMPLE"},"statusModule":{"statusVerifiedDate":"2019-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-11"},"primaryCompletionDateStruct":{"date":"2017-12","type":"ACTUAL"},"completionDateStruct":{"date":"2017-12","type":"ACTUAL"},"studyFirstSubmitDate":"2013-10-17","studyFirstSubmitQcDate":"2013-10-21","studyFirstPostDateStruct":{"date":"2013-10-22","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-08-12","resultsFirstSubmitQcDate":"2019-10-01","resultsFirstPostDateStruct":{"date":"2019-10-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-10-01","lastUpdatePostDateStruct":{"date":"2019-10-22","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Ildiko Lingvay","investigatorTitle":"MD","investigatorAffiliation":"University of Texas Southwestern Medical Center"},"leadSponsor":{"name":"University of Texas Southwestern Medical Center","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus insulin detemir in combination with insulin aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c \\> 10%).","detailedDescription":"The aim of this study is to compare a GLP-1 plus basal insulin and metformin treatment regimen to a basal-bolus plus metformin treatment regimen in patients with very uncontrolled (HbA1c\\>10%) type 2 diabetes. The investigators will compare the two regimens with respect to efficacy in improving glycemic control, rate of hypoglycemia, change in weight, effect on patient quality of life, treatment burden, physician time, as well as healthcare related cost. The investigators hypothesize that at 26 weeks from randomization the two treatment regimens will have similar percentage of patients reaching A1c levels \\<7.0%, while more patients on the GLP-1 plus basal insulin strategy will achieve the composite end point of A1c levels \\<7.0% without severe hypoglycemia or significant weight gain."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2","Diabetes"],"keywords":["Diabetes Mellitus, Type 2","Insulin","Insulin, Long-Acting","Insulin, Short Acting","Detemir","Liraglutide","GLP-1","Glucagon Like Peptide","Metformin","Uncontrolled Diabetes","Elevated A1c","Incretins"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":157,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Control: Metformin, Insulin Detemir, Insulin Aspart","type":"ACTIVE_COMPARATOR","description":"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician","interventionNames":["Drug: Metformin","Drug: Detemir","Drug: Insulin Aspart"]},{"label":"Metformin, insulin determir, Liraglutide","type":"ACTIVE_COMPARATOR","description":"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol\"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)","interventionNames":["Drug: Metformin","Drug: Detemir","Drug: Liraglutide"]}],"interventions":[{"type":"DRUG","name":"Metformin","description":"Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)","armGroupLabels":["Control: Metformin, Insulin Detemir, Insulin Aspart","Metformin, insulin determir, Liraglutide"],"otherNames":["Metformin tablets"]},{"type":"DRUG","name":"Detemir","description":"Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.","armGroupLabels":["Control: Metformin, Insulin Detemir, Insulin Aspart","Metformin, insulin determir, Liraglutide"],"otherNames":["Insulin Detemir subcutaneous once or twice daily"]},{"type":"DRUG","name":"Liraglutide","description":"Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached","armGroupLabels":["Metformin, insulin determir, Liraglutide"],"otherNames":["Liraglutide 6 mg/mL Subcutaneously"]},{"type":"DRUG","name":"Insulin Aspart","description":"Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \\<180","armGroupLabels":["Control: Metformin, Insulin Detemir, Insulin Aspart"],"otherNames":["Insulin Aspart Subcutaneous injection one to three times daily"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Change From Randomization in A1c at Week 26","description":"Change in glycosylated Hemoglobin A1c (A1c) from randomization to 26 weeks of therapy","timeFrame":"Baseline and Week 26"}],"secondaryOutcomes":[{"measure":"Composite End-point","description":"Percentage of participants with glycosylated Hemoglobin A1c (A1c)\\<8% AND no documented severe hypoglycemia (\\<56 mg/dL) during the study AND no significant weight gain (\\>3% from baseline)","timeFrame":"Week 0 (Randomization) , Week 26"},{"measure":"Percentage of Participants Reaching Target A1c of <7% at Week 26","timeFrame":"Week 26"},{"measure":"Percentage of Participants Reaching Pre-specified \"Treatment Failure\" Outcome","description":"Treatment Failure defined as A1c\\>10% at week 13 (visit 5)","timeFrame":"week 13"},{"measure":"Mean Change From Randomization in Body Weight","description":"Change in body weight from randomization to end of study.","timeFrame":"Week 0 (Randomization) , Week 26"},{"measure":"Hypoglycemic Episodes","description":"Percentage of participants experiencing any episodes of documented hypoglycemia defined as CBG reading of \\<70 mg/dl","timeFrame":"Week 0 (Randomization) , Week 2, week 4, week 13, Week 26"},{"measure":"Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means","description":"Diabetes Quality of Life (DQOL) questionnaires will be completed by the patient at the randomization and end-of study visits. ALL D-QOL domains are scored on a 1-5 scale, with a lower number representing better quality of life or treatment satisfaction. Outcome reported is difference between mean baseline and mean Week 26 score.","timeFrame":"Week 0 (Randomization) , Week 26"},{"measure":"Change in Short Form-36 (SF-36) Questionnaire Score","description":"Quality of life questionnaires will be completed by the patient at the randomization and end-of study visits. SF-36 is scored on a 1-100 scale; a higher score represents a better self-assessed health - for all domains.","timeFrame":"Week 0 (Randomization) , Week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1\\. Clinical diagnosis of type 2 diabetes with confirmed HbA1c level \\>10% at time of enrollment, regardless of prior or current treatment regimens, or time since diagnosis.\n\nExclusion Criteria:\n\n1. Age \\<18 as the feasibility and safety of this treatment regimen should be first established in the adult population; if successful, a subsequent pediatric study will be proposed;\n2. Type 1 diabetes as purposefully withholding meal-time insulin is contraindicated;\n3. Clinical state requiring inpatient admission/treatment;\n4. Contraindication or strong cautions to any of the study medications:\n\n   1. Creatinine above 1.4 mg/dl for women and 1.5 mg/dl for men (per metformin label)\n   2. History of lactic acidosis (per metformin label)\n   3. Advanced hepatic or cardiac disease (per metformin label)\n   4. Age \\>80 years (per metformin label)\n   5. Chronic alcohol use (\\>14 drinks/week)\n   6. History of pancreatitis (per liraglutide label)\n   7. Personal or family history of medullary thyroid cancer or MEN syndrome (per liraglutide label)\n   8. Pregnancy and lactation (per liraglutide label)\n5. Any serious or unstable medical condition as it would interfere with treatment assignment as well as outcome measurement;\n6. Any scheduled elective procedures/surgeries;\n7. Active infections, including osteomyelitis;\n8. Not willing to participate, unable to keep projected appointments, unwillingness to receive injectable treatment; unwillingness to perform 7-point glucose profiles over 2 consecutive days the weeks prior to Randomization (visit 1)and the week prior to visit 6\n9. Non English speaking.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Ildiko Lingvay","affiliation":"University of Texas Southwestern Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"UT Southwestern Medical Center","city":"Dallas","state":"Texas","zip":"02720","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}}]},"referencesModule":{"references":[{"pmid":"31803482","type":"DERIVED","citation":"Patel S, Abreu M, Tumyan A, Adams-Huet B, Li X, Lingvay I. Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study. BMJ Open Diabetes Res Care. 2019 Nov 18;7(1):e000761. doi: 10.1136/bmjdrc-2019-000761. eCollection 2019."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Total number of subjects consented is 157, total number of subjects randomized is 120, of those 120 only 110 are MITT data set","groups":[{"id":"FG000","title":"Control: Metformin, Insulin Detemir, Insulin Aspart","description":"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nInsulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \\<180"},{"id":"FG001","title":"Metformin, Insulin Determir, Liraglutide","description":"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol\"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nLiraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"61"},{"groupId":"FG001","numSubjects":"59"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"44"},{"groupId":"FG001","numSubjects":"46"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"13"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Control: Metformin, Insulin Detemir, Insulin Aspart","description":"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nInsulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \\<180"},{"id":"BG001","title":"Metformin, Insulin Determir, Liraglutide","description":"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol\"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nLiraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"61"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"120"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48.1","spread":"10.0"},{"groupId":"BG001","value":"46.7","spread":"9.0"},{"groupId":"BG002","value":"47.4","spread":"9.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"85"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"35"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"48"}]}]},{"title":"Non-Hispanic White","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"22"}]}]},{"title":"African-American","categories":[{"measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"50"}]}]}]},{"title":"HbA1c","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of glycosylated hemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12.0","spread":"1.5"},{"groupId":"BG001","value":"12.1","spread":"1.4"},{"groupId":"BG002","value":"12.1","spread":"1.4"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean Change From Randomization in A1c at Week 26","description":"Change in glycosylated Hemoglobin A1c (A1c) from randomization to 26 weeks of therapy","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Percentage of glycosylated hemoglobin","timeFrame":"Baseline and Week 26","groups":[{"id":"OG000","title":"Control: Metformin, Insulin Detemir, Insulin Aspart","description":"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nInsulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \\<180"},{"id":"OG001","title":"Metformin, Insulin Determir, Liraglutide","description":"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol\"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nLiraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"46"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.4","lowerLimit":"2.4","upperLimit":"3.7"},{"groupId":"OG001","value":"4.1","lowerLimit":"3.5","upperLimit":"4.8"}]}]}]},{"type":"SECONDARY","title":"Composite End-point","description":"Percentage of participants with glycosylated Hemoglobin A1c (A1c)\\<8% AND no documented severe hypoglycemia (\\<56 mg/dL) during the study AND no significant weight gain (\\>3% from baseline)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 0 (Randomization) , Week 26","groups":[{"id":"OG000","title":"Control: Metformin, Insulin Detemir, Insulin Aspart","description":"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nInsulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \\<180"},{"id":"OG001","title":"Metformin, Insulin Determir, Liraglutide","description":"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol\"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nLiraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"46"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"34"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Reaching Target A1c of <7% at Week 26","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Control: Metformin, Insulin Detemir, Insulin Aspart","description":"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nInsulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \\<180"},{"id":"OG001","title":"Metformin, Insulin Determir, Liraglutide","description":"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol\"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nLiraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"46"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"44"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Reaching Pre-specified \"Treatment Failure\" Outcome","description":"Treatment Failure defined as A1c\\>10% at week 13 (visit 5)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"week 13","groups":[{"id":"OG000","title":"Control: Metformin, Insulin Detemir, Insulin Aspart","description":"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nInsulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \\<180"},{"id":"OG001","title":"Metformin, Insulin Determir, Liraglutide","description":"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol\"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nLiraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"46"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.1"},{"groupId":"OG001","value":"7.4"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Randomization in Body Weight","description":"Change in body weight from randomization to end of study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"kilogram","timeFrame":"Week 0 (Randomization) , Week 26","groups":[{"id":"OG000","title":"Control: Metformin, Insulin Detemir, Insulin Aspart","description":"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nInsulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \\<180"},{"id":"OG001","title":"Metformin, Insulin Determir, Liraglutide","description":"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol\"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nLiraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"46"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.1","lowerLimit":"1.7","upperLimit":"4.6"},{"groupId":"OG001","value":"-0.6","lowerLimit":"-0.9","upperLimit":"2.1"}]}]}]},{"type":"SECONDARY","title":"Hypoglycemic Episodes","description":"Percentage of participants experiencing any episodes of documented hypoglycemia defined as CBG reading of \\<70 mg/dl","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 0 (Randomization) , Week 2, week 4, week 13, Week 26","groups":[{"id":"OG000","title":"Control: Metformin, Insulin Detemir, Insulin Aspart","description":"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nInsulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \\<180"},{"id":"OG001","title":"Metformin, Insulin Determir, Liraglutide","description":"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol\"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nLiraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"46"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"66.1"},{"groupId":"OG001","value":"35.2"}]}]}]},{"type":"SECONDARY","title":"Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means","description":"Diabetes Quality of Life (DQOL) questionnaires will be completed by the patient at the randomization and end-of study visits. ALL D-QOL domains are scored on a 1-5 scale, with a lower number representing better quality of life or treatment satisfaction. Outcome reported is difference between mean baseline and mean Week 26 score.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 0 (Randomization) , Week 26","groups":[{"id":"OG000","title":"Control: Metformin, Insulin Detemir, Insulin Aspart","description":"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nInsulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \\<180"},{"id":"OG001","title":"Metformin, Insulin Determir, Liraglutide","description":"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol\"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nLiraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"46"}]}],"classes":[{"title":"General Health Perception","categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","lowerLimit":"-0.6","upperLimit":"-0.1"},{"groupId":"OG001","value":"-0.9","lowerLimit":"-1.1","upperLimit":"-0.6"}]}]},{"title":"Current Health Perception","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","lowerLimit":"-0.9","upperLimit":"-0.1"},{"groupId":"OG001","value":"-1.1","lowerLimit":"-1.5","upperLimit":"-0.7"}]}]},{"title":"Treatment Satisfaction","categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","lowerLimit":"-0.5","upperLimit":"-0.04"},{"groupId":"OG001","value":"-0.6","lowerLimit":"-0.8","upperLimit":"-0.4"}]}]},{"title":"Diabetes Related Worry","categories":[{"measurements":[{"groupId":"OG000","value":"0.03","lowerLimit":"-0.1","upperLimit":"0.2"},{"groupId":"OG001","value":"-0.2","lowerLimit":"-0.4","upperLimit":"-0.04"}]}]},{"title":"Social or Vocational Worry","categories":[{"measurements":[{"groupId":"OG000","value":"-0.02","lowerLimit":"-0.3","upperLimit":"0.3"},{"groupId":"OG001","value":"-0.2","lowerLimit":"-0.4","upperLimit":"0.08"}]}]},{"title":"Hypoglycemia Fear","categories":[{"measurements":[{"groupId":"OG000","value":"0.3","lowerLimit":"0.04","upperLimit":"0.5"},{"groupId":"OG001","value":"-0.2","lowerLimit":"-0.4","upperLimit":"-0.005"}]}]},{"title":"Glycemic Control Perception","categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","lowerLimit":"-1.6","upperLimit":"-0.7"},{"groupId":"OG001","value":"-1.6","lowerLimit":"-2.0","upperLimit":"-1.2"}]}]},{"title":"Satisfaction with Insulin Treatment","categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","lowerLimit":"-1.8","upperLimit":"-0.8"},{"groupId":"OG001","value":"-1.7","lowerLimit":"-2.2","upperLimit":"-1.2"}]}]},{"title":"Willingness to Continue Insulin Treatment","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","lowerLimit":"-1.4","upperLimit":"-0.3"},{"groupId":"OG001","value":"-1.1","lowerLimit":"-1.7","upperLimit":"-0.6"}]}]},{"title":"LifeStyle Flexibility","categories":[{"measurements":[{"groupId":"OG000","value":"-0.09","lowerLimit":"-0.4","upperLimit":"0.2"},{"groupId":"OG001","value":"-0.2","lowerLimit":"-0.4","upperLimit":"0.1"}]}]},{"title":"Social Stigma","categories":[{"measurements":[{"groupId":"OG000","value":"0.1","lowerLimit":"-0.2","upperLimit":"0.4"},{"groupId":"OG001","value":"0.01","lowerLimit":"-0.3","upperLimit":"0.4"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form-36 (SF-36) Questionnaire Score","description":"Quality of life questionnaires will be completed by the patient at the randomization and end-of study visits. 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Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nInsulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \\<180"},{"id":"OG001","title":"Metformin, Insulin Determir, Liraglutide","description":"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol\"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nLiraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"46"}]}],"classes":[{"title":"Physical Component Summary","categories":[{"measurements":[{"groupId":"OG000","value":"-0.1","lowerLimit":"-0.4","upperLimit":"0.2"},{"groupId":"OG001","value":"0.007","lowerLimit":"-0.3","upperLimit":"0.3"}]}]},{"title":"Mental Component Summary","categories":[{"measurements":[{"groupId":"OG000","value":"0.04","lowerLimit":"-0.1","upperLimit":"0.1"},{"groupId":"OG001","value":"0.09","lowerLimit":"-0.02","upperLimit":"0.2"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"6 months (Baseline to Week 26)","description":"Adverse events were collected both by self-report as well as review of the electronic health record. Nausea, vomiting, headache, diarrhea and abdominal pain were pre-defined events of special interest and proactively elicited at each visit from all patients.","eventGroups":[{"id":"EG000","title":"Control: Metformin, Insulin Detemir, Insulin Aspart","description":"Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nInsulin Aspart: Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \\<180","deathsNumAffected":0,"deathsNumAtRisk":56,"seriousNumAffected":13,"seriousNumAtRisk":56,"otherNumAffected":40,"otherNumAtRisk":56},{"id":"EG001","title":"Metformin, Insulin Determir, Liraglutide","description":"Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol\"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)\n\nMetformin: Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)\n\nDetemir: Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.\n\nLiraglutide: Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached","deathsNumAffected":0,"deathsNumAtRisk":54,"seriousNumAffected":6,"seriousNumAtRisk":54,"otherNumAffected":50,"otherNumAtRisk":54}],"seriousEvents":[{"term":"Pneumonia","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":56},{"groupId":"EG001","numAffected":0,"numAtRisk":54}]},{"term":"Facial Burn","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":56},{"groupId":"EG001","numAffected":0,"numAtRisk":54}]},{"term":"Urinary Tract Infection","organSystem":"Renal and urinary disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":56},{"groupId":"EG001","numAffected":0,"numAtRisk":54}]},{"term":"Respiratory Distress","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":56},{"groupId":"EG001","numAffected":0,"numAtRisk":54}]},{"term":"Pregnancy","organSystem":"Pregnancy, puerperium and perinatal conditions","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":56},{"groupId":"EG001","numAffected":1,"numAtRisk":54}]},{"term":"Small Bowel Obstruction","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":56},{"groupId":"EG001","numAffected":0,"numAtRisk":54}]},{"term":"Fall","organSystem":"Investigations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":56},{"groupId":"EG001","numAffected":0,"numAtRisk":54}]},{"term":"chest pain","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":56},{"groupId":"EG001","numAffected":1,"numAtRisk":54}]},{"term":"Diabetic Ketoacidosis","organSystem":"Endocrine disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":56},{"groupId":"EG001","numAffected":0,"numAtRisk":54}]},{"term":"Osteomyelitis","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":56},{"groupId":"EG001","numAffected":0,"numAtRisk":54}]},{"term":"hypertension","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":56},{"groupId":"EG001","numAffected":1,"numAtRisk":54}]},{"term":"myocardial infarction","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":56},{"groupId":"EG001","numAffected":1,"numAtRisk":54}]},{"term":"nasopharyngeal carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":56},{"groupId":"EG001","numAffected":0,"numAtRisk":54}]},{"term":"psychiatric inpatient hospitalization","organSystem":"Psychiatric 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disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":56},{"groupId":"EG001","numAffected":0,"numAtRisk":54}]},{"term":"Lower GI bleed","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":56},{"groupId":"EG001","numAffected":0,"numAtRisk":54}]},{"term":"glaucoma","organSystem":"Eye disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":56},{"groupId":"EG001","numAffected":1,"numAtRisk":54}]}],"otherEvents":[{"term":"headache","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":56},{"groupId":"EG001","numAffected":14,"numAtRisk":54}]},{"term":"GI","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":56},{"groupId":"EG001","numAffected":42,"numAtRisk":54}]},{"term":"Other AE","organSystem":"Investigations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":56},{"groupId":"EG001","numAffected":4,"numAtRisk":54}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Ildiko Lingvay","organization":"UT Southwestern Medical Center","email":"ildiko.lingvay@utsouthwestern.edu","phone":"214-648-2779"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis 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