{"protocolSection":{"identificationModule":{"nctId":"NCT02060383","orgStudyIdInfo":{"id":"CSOM230B2219"},"secondaryIdInfos":[{"id":"2012-002916-16","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Novartis","class":"INDUSTRY"},"briefTitle":"Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly","officialTitle":"A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly"},"statusModule":{"statusVerifiedDate":"2019-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-05-23","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-02-05","type":"ACTUAL"},"completionDateStruct":{"date":"2018-03-26","type":"ACTUAL"},"studyFirstSubmitDate":"2014-02-10","studyFirstSubmitQcDate":"2014-02-11","studyFirstPostDateStruct":{"date":"2014-02-12","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-02-28","resultsFirstSubmitQcDate":"2019-05-07","resultsFirstPostDateStruct":{"date":"2019-05-29","type":"ACTUAL"},"dispFirstSubmitDate":"2018-10-12","dispFirstSubmitQcDate":"2018-10-19","dispFirstPostDateStruct":{"date":"2018-10-23","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-05-07","lastUpdatePostDateStruct":{"date":"2019-05-29","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novartis Pharmaceuticals","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The study was designed to investigate the optimal management of hyperglycemia developed during pasireotide treatment in participants with Cushing's disease or Acromegaly, which was not manageable with metformin.\n\nThis was a Phase IV, multi-center, randomized, open-label study. Eligible patients started pasireotide subcutaneously (s.c.) for Cushing's disease and pasireotide LAR (long-acting release) for Acromegaly.\n\nParticipants being treated with pasireotide s.c or LAR at screening were eligible as long as they met protocol criteria during the screening period. If previously normo-glycemic participants experienced an increase in their fasting blood glucose and met the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they continued to have elevated blood glucose above target on metformin within the first 16 weeks, they were randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks.\n\nParticipants who continued to receive clinical benefit after completing the Core Phase could enter an optional Extension Phase if pasireotide was not commercially available in their country or a local access program was not available to provide drug. Patients continued in the Extension Phase until the last participant randomized in the Core Phase completed 16 weeks of treatment post-randomization."},"conditionsModule":{"conditions":["Cushing's Disease","Acromegaly"],"keywords":["Cushing's disease","acromegaly","pasireotide","hyperglycemia"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"SUPPORTIVE_CARE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":249,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Incretin based therapy (randomized group)","type":"EXPERIMENTAL","description":"Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin.","interventionNames":["Drug: Pasireotide s.c.","Drug: Sitagliptin","Drug: Liraglutide","Drug: Insulin","Drug: Pasireotide LAR","Drug: Metformin"]},{"label":"Insulin (randomized group)","type":"EXPERIMENTAL","description":"Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin.","interventionNames":["Drug: Pasireotide s.c.","Drug: Insulin","Drug: Pasireotide LAR","Drug: Metformin"]},{"label":"Non-Randomized Arm","type":"OTHER","description":"This arm represents the non-randomized participants: Cushing's Disease (CD) or Acromegaly participants, who received pasireotide s.c. or LAR (long-acting release) respectively, but who were not randomized to the Incretin or Insulin arms.\n\nFor the purpose of analysis, this non-randomized arm is further split into 3 groups:\n\n* Baseline insulin group (BL insulin) includes participants who were receiving insulin at study entry\n* Oral antidiabetic drugs (OAD) group includes participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment\n* No OAD group includes participants who did not receive any anti-diabetic medication during the core phase of the trial","interventionNames":["Drug: Pasireotide s.c.","Drug: Insulin","Drug: Pasireotide LAR","Drug: Metformin"]}],"interventions":[{"type":"DRUG","name":"Pasireotide s.c.","description":"Administered to Cushing's disease participants.","armGroupLabels":["Incretin based therapy (randomized group)","Insulin (randomized group)","Non-Randomized Arm"],"otherNames":["SOM230"]},{"type":"DRUG","name":"Sitagliptin","description":"Taken for approximately 16 weeks during the core study phase or until the drug was found not to be effective","armGroupLabels":["Incretin based therapy (randomized group)"]},{"type":"DRUG","name":"Liraglutide","description":"Participant switched to liraglutide if sitagliptin was found not to be effective.","armGroupLabels":["Incretin based therapy (randomized group)"]},{"type":"DRUG","name":"Insulin","description":"Participant took insulin for 16 weeks. Insulin was also administered as rescue therapy in the incretin-based therapy arm if required.\n\nInsulin was administered to the BL-insulin group at the discretion of the Principal Investigator.\n\nNote: OAD and No OAD groups within the non-randomized arm did not take Insulin.","armGroupLabels":["Incretin based therapy (randomized group)","Insulin (randomized group)","Non-Randomized Arm"]},{"type":"DRUG","name":"Pasireotide LAR","description":"Administered to Acromegaly participants.","armGroupLabels":["Incretin based therapy (randomized group)","Insulin (randomized group)","Non-Randomized Arm"],"otherNames":["SOM230"]},{"type":"DRUG","name":"Metformin","description":"If previously normo-glycemic participants experienced increase in their fasting blood glucose and meeting the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they continued to experience increase in their fasting blood glucose within the first 16 weeks, they were randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks. Metformin treatment was not required for the BL Insulin and OAD groups, within the non-randomized arm, but may have been prescribed at the discretion of the investigator.\n\nNote: No OAD group within the non-randomized arm did not take metformin.","armGroupLabels":["Incretin based therapy (randomized group)","Insulin (randomized group)","Non-Randomized Arm"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c From Randomization to Approximately 16 Weeks","description":"Absolute change in HbA1c from randomization to end of core phase (16 weeks) in incretin based therapy arm and insulin arm, and mean difference of change in HbA1c between the two treatment groups based on an ANOVA model using treatment (Incretin, Insulin) and the two randomization stratification factors (Disease: Cushing's disease vs Acromegaly; Baseline glycemic status: HbA1c \\<7% vs HbA1c ≥ 7%) as fixed effects. For Participants who discontinued the study or required rescue treatment before the time of assessing the primary endpoint, the last HbA1c assessment collected 8 weeks (56 days) after randomization (and prior to or on the date of start of rescue treatment) was carried forward. If the participant discontinued the study or used rescue treatment within 8 weeks after randomization, it was considered missing.","timeFrame":"Randomization, 16 weeks"}],"secondaryOutcomes":[{"measure":"Change in HbA1c From Randomization (R) Over Time Per Randomized Arm","description":"Absolute change in HbA1c overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm","timeFrame":"Randomization (R), Week (W) 4 post R, W 8 post R, W 16 post R, end of Core phase (up to week 16 post R)"},{"measure":"Change in FPG (Fasting Plasma Glucose) From Randomization Until End of Core Phase","description":"Absolute change in fasting glucose overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm","timeFrame":"Randomization, R(randomization) Week 2, R-Week 4, R-Week 6, R-Week 8, R-Week 10, R-Week 12, R-Week 14, R-Week 16, end of Core phase"},{"measure":"Percentage of Participants in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin","description":"The percentage of participants who received anti-diabetic rescue therapy in incretin based therapy is summarized.","timeFrame":"Randomization to up to 16 weeks"},{"measure":"Absolute Change in HbA1c From Baseline to End of Core Phase","description":"Absolute change in HbA1c from baseline to end of core phase in the incretin based therapy arm and the insulin arm","timeFrame":"Baseline, up to 32 weeks (end of Core phase)"},{"measure":"Absolute Change in FPG From Baseline to End of Core Phase","description":"Absolute change in FPG from baseline to end of core phase in the incretin based therapy arm and the insulin arm.","timeFrame":"Baseline, Up to 32 weeks (end of Core Phase)"},{"measure":"Percentage of Participants With ≤ 0.3% HbA1c Increase to End of Core Phase","description":"Percentage of participants with ≤ 0.3% HbA1c increase in the incretin based therapy arm and the insulin arm.","timeFrame":"Randomization, up to 16 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients greater than or equal to 18 years old\n* Confirmed diagnosis of Cushing's disease or acromegaly\n\nExclusion Criteria:\n\n* Patients who require surgical intervention\n* Patients receiving DPP-4 inhibitors or GLP-1 receptor agonists within 4 weeks prior to study entry\n* HbA1c \\> 10 % at screening\n* Known hypersensitivity to somatostatin analogues Other protocol-defined inclusion/exclusion criteria may apply.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Novartis Pharmaceuticals","affiliation":"Novartis Pharmaceuticals","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Diabetes and Endocrine Associates La Mesa Location","city":"Multiple Locations","state":"California","country":"United States"},{"facility":"LA Biomedical Research at Harbor UCLA 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(Türkiye)","geoPoint":{"lat":36.90812,"lon":30.69556}}]},"referencesModule":{"references":[{"pmid":"34275099","type":"DERIVED","citation":"Samson SL, Gu F, Feldt-Rasmussen U, Zhang S, Yu Y, Witek P, Kalra P, Pedroncelli AM, Pultar P, Jabbour N, Paul M, Bolanowski M. Managing pasireotide-associated hyperglycemia: a randomized, open-label, Phase IV study. Pituitary. 2021 Dec;24(6):887-903. doi: 10.1007/s11102-021-01161-4. Epub 2021 Jul 18."},{"pmid":"27405306","type":"DERIVED","citation":"Silverstein JM. Hyperglycemia induced by pasireotide in patients with Cushing's disease or acromegaly. Pituitary. 2016 Oct;19(5):536-43. doi: 10.1007/s11102-016-0734-1."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"249 participants were included in study \\& treated with pasireotide s.c. (59 with Cushing's disease) or pasireotide LAR (190 with acromegaly). Following pre-randomization period (up to 16 weeks), 81 participants were randomized to either incretin-based therapy or insulin (72 evaluable for the primary analysis) \\& 168 not qualified for randomization.","recruitmentDetails":"A total of 68 randomized evaluable participants with at least 8 weeks of randomized treatment without any rescue anti-diabetic medication was required. Approximately 79 participants were planned to be randomized.","groups":[{"id":"FG000","title":"Incretin Based Therapy (Randomized Group)","description":"Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin"},{"id":"FG001","title":"Insulin (Randomized Group)","description":"Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin."},{"id":"FG002","title":"Baseline Insulin (BL) (Non-randomized Group)","description":"This group included participants who were receiving insulin at study entry."},{"id":"FG003","title":"Oral Antidiabetic Drugs (OAD) (Non-randomized Group)","description":"This group included participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment. Patients in this group did not require additional treatment with either incretin or insulin."},{"id":"FG004","title":"No OAD (Non-randomized Group)","description":"This group included participants who did not receive any anti-diabetic medication during the Core Phase of the study as they did not develop hyperglycemia."}],"periods":[{"title":"Core Phase","milestones":[{"type":"STARTED","comment":"Entered Core Phase of Study","achievements":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"43"},{"groupId":"FG002","numSubjects":"19"},{"groupId":"FG003","numSubjects":"46"},{"groupId":"FG004","numSubjects":"103"}]},{"type":"Completed Core/Entered Extension","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"21"},{"groupId":"FG004","numSubjects":"53"}]},{"type":"Completed Core/Did Not Enter Extension","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"18"},{"groupId":"FG004","numSubjects":"42"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"37"},{"groupId":"FG002","numSubjects":"19"},{"groupId":"FG003","numSubjects":"39"},{"groupId":"FG004","numSubjects":"95"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"8"}]}],"dropWithdraws":[{"type":"Unsatisfactory therapeutic effect","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"6"}]},{"type":"Administrative problems","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"2"}]}]},{"title":"Extension Phase","milestones":[{"type":"STARTED","comment":"Entered the Extension phase from the Core phase","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"21"},{"groupId":"FG004","numSubjects":"53"}]},{"type":"COMPLETED","comment":"Completed the Extension phase","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"19"},{"groupId":"FG004","numSubjects":"46"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"7"}]}],"dropWithdraws":[{"type":"Unsatisfactory therapeutic effect","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"2"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"2"}]},{"type":"Administrative problems","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full Analysis Set (FAS): all participants who received at least one dose of pasireotide.","groups":[{"id":"BG000","title":"Incretin Based Therapy (Randomized Group)","description":"Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin"},{"id":"BG001","title":"Insulin (Randomized Group)","description":"Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin."},{"id":"BG002","title":"Baseline Insulin (BL) (Non-randomized Group)","description":"This group included participants who were receiving insulin at study entry."},{"id":"BG003","title":"Oral Antidiabetic Drugs (OAD) (Non-randomized Group)","description":"This group included participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment. Patients in this group did not require additional treatment with either incretin or insulin."},{"id":"BG004","title":"No OAD (Non-randomized Group)","description":"This group included participants who did not receive any anti-diabetic medication during the Core Phase of the study as they did not develop hyperglycemia."},{"id":"BG005","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"43"},{"groupId":"BG002","value":"19"},{"groupId":"BG003","value":"46"},{"groupId":"BG004","value":"103"},{"groupId":"BG005","value":"249"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"50.6","spread":"11.76"},{"groupId":"BG001","value":"46.4","spread":"12.90"},{"groupId":"BG002","value":"46.7","spread":"12.54"},{"groupId":"BG003","value":"40.2","spread":"13.80"},{"groupId":"BG004","value":"37.8","spread":"11.17"},{"groupId":"BG005","value":"42.4","spread":"13.05"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"31"},{"groupId":"BG004","value":"47"},{"groupId":"BG005","value":"137"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"15"},{"groupId":"BG004","value":"56"},{"groupId":"BG005","value":"112"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"25"},{"groupId":"BG004","value":"43"},{"groupId":"BG005","value":"125"}]}]},{"title":"Chinese","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"13"},{"groupId":"BG004","value":"33"},{"groupId":"BG005","value":"61"}]}]},{"title":"Hispanic/Latino","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"19"},{"groupId":"BG005","value":"39"}]}]},{"title":"Indian (Indian subcontinent)","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"23"}]}]},{"title":"Japanese","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"1"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c From Randomization to Approximately 16 Weeks","description":"Absolute change in HbA1c from randomization to end of core phase (16 weeks) in incretin based therapy arm and insulin arm, and mean difference of change in HbA1c between the two treatment groups based on an ANOVA model using treatment (Incretin, Insulin) and the two randomization stratification factors (Disease: Cushing's disease vs Acromegaly; Baseline glycemic status: HbA1c \\<7% vs HbA1c ≥ 7%) as fixed effects. For Participants who discontinued the study or required rescue treatment before the time of assessing the primary endpoint, the last HbA1c assessment collected 8 weeks (56 days) after randomization (and prior to or on the date of start of rescue treatment) was carried forward. If the participant discontinued the study or used rescue treatment within 8 weeks after randomization, it was considered missing.","populationDescription":"Randomized Analysis Set (RAS): all patients who received at least one dose of pasireotide and were assigned to either incretin based therapy or insulin by randomization.\n\nIf the patient discontinued the study or used rescue treatment within 8 weeks after randomization, it was considered missing.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Hba1c percentage","timeFrame":"Randomization, 16 weeks","groups":[{"id":"OG000","title":"Incretin Based Therapy (Randomized Group)","description":"Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin"},{"id":"OG001","title":"Insulin (Randomized Group)","description":"Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"41"}]}],"classes":[{"title":"All Patients","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"41"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.12","lowerLimit":"-0.36","upperLimit":"0.13"},{"groupId":"OG001","value":"0.26","lowerLimit":"-0.01","upperLimit":"0.53"}]}]},{"title":"Cushing's Disease","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"11"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.33","lowerLimit":"-0.41","upperLimit":"1.07"},{"groupId":"OG001","value":"0.45","lowerLimit":"-0.20","upperLimit":"1.09"}]}]},{"title":"Acromegaly","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"30"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.25","lowerLimit":"-0.49","upperLimit":"-0.00"},{"groupId":"OG001","value":"0.19","lowerLimit":"-0.12","upperLimit":"0.49"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"All Patients","nonInferiorityType":"OTHER","nonInferiorityComment":"There was no formal hypothesis testing planned in this study.","paramType":"Mean Difference (Net)","paramValue":"-0.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.63","ciUpperLimit":"0.08","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.18","estimateComment":"Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (Cushing's vs. Acromegaly; baseline HbA1c \\<7% vs ≥7%) as fixed effects."},{"groupIds":["OG000","OG001"],"groupDescription":"Cushing's Disease","nonInferiorityType":"OTHER","nonInferiorityComment":"There was no formal hypothesis testing planned in this study.","paramType":"Mean Difference (Net)","paramValue":"-0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.96","ciUpperLimit":"0.95","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.45","estimateComment":"Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c \\<7% vs ≥7%) as fixed effects."},{"groupIds":["OG000","OG001"],"groupDescription":"Acromegaly","nonInferiorityType":"OTHER","nonInferiorityComment":"There was no formal hypothesis testing planned in this study.","paramType":"Mean Difference (Net)","paramValue":"-0.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.74","ciUpperLimit":"0.02","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.19","estimateComment":"Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c \\<7% vs ≥7%) as fixed effects."}]},{"type":"SECONDARY","title":"Change in HbA1c From Randomization (R) Over Time Per Randomized Arm","description":"Absolute change in HbA1c overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm","populationDescription":"Randomized Analysis Set (RAS): all patients who received at least one dose of pasireotide and were assigned to either incretin based therapy or insulin by randomization.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"HbA1c percentage","timeFrame":"Randomization (R), Week (W) 4 post R, W 8 post R, W 16 post R, end of Core phase (up to week 16 post R)","groups":[{"id":"OG000","title":"Incretin Based Therapy (Randomized Group)","description":"Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin"},{"id":"OG001","title":"Insulin (Randomized Group)","description":"Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"43"}]}],"classes":[{"title":"Randomization","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"43"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.1","spread":"1.00"},{"groupId":"OG001","value":"7.1","spread":"0.75"}]}]},{"title":"Change at RW4 D29","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"43"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"0.73"},{"groupId":"OG001","value":"0.5","spread":"0.60"}]}]},{"title":"Change at RW8 D57","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"43"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.3","spread":"0.98"},{"groupId":"OG001","value":"0.5","spread":"0.86"}]}]},{"title":"Change at RW12 D85","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"40"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"1.03"},{"groupId":"OG001","value":"0.4","spread":"0.85"}]}]},{"title":"Change at RW16 D113","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"37"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.93"},{"groupId":"OG001","value":"0.3","spread":"0.87"}]}]},{"title":"End of Core Phase","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"42"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.92"},{"groupId":"OG001","value":"0.3","spread":"0.84"}]}]}]},{"type":"SECONDARY","title":"Change in FPG (Fasting Plasma Glucose) From Randomization Until End of Core Phase","description":"Absolute change in fasting glucose overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm","populationDescription":"Randomized Analysis Set (RAS): all patients who received at least one dose of pasireotide and were assigned to either incretin based therapy or insulin by randomization.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"Randomization, R(randomization) Week 2, R-Week 4, R-Week 6, R-Week 8, R-Week 10, R-Week 12, R-Week 14, R-Week 16, end of Core phase","groups":[{"id":"OG000","title":"Incretin Based Therapy (Randomized Group)","description":"Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin"},{"id":"OG001","title":"Insulin (Randomized Group)","description":"Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"43"}]}],"classes":[{"title":"Randomization","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"43"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"172.2","spread":"60.78"},{"groupId":"OG001","value":"167.9","spread":"40.77"}]}]},{"title":"Change at RW2 D15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"42"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.6","spread":"51.01"},{"groupId":"OG001","value":"-31.1","spread":"41.19"}]}]},{"title":"Change at RW4 D29","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"43"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-15.0","spread":"47.95"},{"groupId":"OG001","value":"-28.3","spread":"41.14"}]}]},{"title":"Change at RW6 D43","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"41"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-17.7","spread":"57.97"},{"groupId":"OG001","value":"-37.5","spread":"52.39"}]}]},{"title":"Change at RW8 D57","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"42"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-25.7","spread":"53.32"},{"groupId":"OG001","value":"-38.3","spread":"44.10"}]}]},{"title":"Change at RW10 D71","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"37"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-28.8","spread":"61.14"},{"groupId":"OG001","value":"-36.9","spread":"50.82"}]}]},{"title":"Change at RW12 D85","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"40"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-33.4","spread":"50.17"},{"groupId":"OG001","value":"-41.1","spread":"51.68"}]}]},{"title":"Change at RW14 D99","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"36"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-35.1","spread":"55.83"},{"groupId":"OG001","value":"-35.6","spread":"47.43"}]}]},{"title":"Change at RW16 D113","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"34"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-38.8","spread":"53.69"},{"groupId":"OG001","value":"-33.4","spread":"47.63"}]}]},{"title":"End of Core Phase","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"41"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-40.1","spread":"56.35"},{"groupId":"OG001","value":"-36.0","spread":"46.90"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin","description":"The percentage of participants who received anti-diabetic rescue therapy in incretin based therapy is summarized.","populationDescription":"Safety set - All participants randomized to the incretin-based therapy who received at least one dose of pasireotide and had at least one post-baseline safety assessment. Randomized participants within the safety set were analyzed according to the anti-diabetic study treatment first received.","reportingStatus":"POSTED","paramType":"NUMBER","dispersionType":"95% Confidence Interval","unitOfMeasure":"Percentage of participants","timeFrame":"Randomization to up to 16 weeks","groups":[{"id":"OG000","title":"Incretin Based Therapy (Randomized Group)","description":"Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"31.6","lowerLimit":"17.5","upperLimit":"48.7"}]}]}]},{"type":"SECONDARY","title":"Absolute Change in HbA1c From Baseline to End of Core Phase","description":"Absolute change in HbA1c from baseline to end of core phase in the incretin based therapy arm and the insulin arm","populationDescription":"Full Analysis Set (FAS): Participants who received at least 1 dose of pasireotide. Randomized participants were analyzed according to the anti-diabetic treatment assigned to at randomization. Non-randomized participants were analyzed by the anti-diabetic treatment received during the core phase (insulin at baseline, oral antidiabetics (OAD), none).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"HbA1c percentage","timeFrame":"Baseline, up to 32 weeks (end of Core phase)","groups":[{"id":"OG000","title":"Incretin Based Therapy (Randomized Group)","description":"Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin"},{"id":"OG001","title":"Insulin (Randomized Group)","description":"Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin."},{"id":"OG002","title":"Baseline Insulin (BL) (Non-randomized Group)","description":"This group included participants who were receiving insulin at study entry."},{"id":"OG003","title":"Oral Antidiabetic Drugs (OAD) (Non-randomized Group)","description":"This group included participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment. Patients in this group did not require additional treatment with either incretin or insulin."},{"id":"OG004","title":"No OAD (Non-randomized Group)","description":"This group included participants who did not receive any anti-diabetic medication during the Core Phase of the study as they did not develop hyperglycemia."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"46"},{"groupId":"OG004","value":"103"}]}],"classes":[{"title":"Baseline: All Patients","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"46"},{"groupId":"OG004","value":"102"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.3","spread":"0.80"},{"groupId":"OG001","value":"6.3","spread":"0.63"},{"groupId":"OG002","value":"7.7","spread":"1.51"},{"groupId":"OG003","value":"5.7","spread":"0.41"},{"groupId":"OG004","value":"5.4","spread":"0.33"}]}]},{"title":"Change at EOP: All Patients","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"45"},{"groupId":"OG004","value":"100"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"0.97"},{"groupId":"OG001","value":"1.1","spread":"0.94"},{"groupId":"OG002","value":"1.3","spread":"1.40"},{"groupId":"OG003","value":"0.8","spread":"0.64"},{"groupId":"OG004","value":"0.4","spread":"0.32"}]}]},{"title":"Baseline: Cushing's","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"15"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.6","spread":"0.87"},{"groupId":"OG001","value":"6.5","spread":"0.58"},{"groupId":"OG002","value":"6.9","spread":"0.92"},{"groupId":"OG003","value":"5.9","spread":"0.49"},{"groupId":"OG004","value":"5.5","spread":"0.41"}]}]},{"title":"Change at EOP: Cushing's","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"14"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"1.19"},{"groupId":"OG001","value":"1.7","spread":"1.05"},{"groupId":"OG002","value":"1.4","spread":"1.58"},{"groupId":"OG003","value":"0.9","spread":"0.95"},{"groupId":"OG004","value":"0.5","spread":"0.51"}]}]},{"title":"Baseline: Acromegaly","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"33"},{"groupId":"OG004","value":"87"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.1","spread":"0.71"},{"groupId":"OG001","value":"6.3","spread":"0.65"},{"groupId":"OG002","value":"8.0","spread":"1.61"},{"groupId":"OG003","value":"5.6","spread":"0.36"},{"groupId":"OG004","value":"5.4","spread":"0.32"}]}]},{"title":"Change at EOP: Acromegaly","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"32"},{"groupId":"OG004","value":"86"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"0.78"},{"groupId":"OG001","value":"0.8","spread":"0.78"},{"groupId":"OG002","value":"1.2","spread":"1.37"},{"groupId":"OG003","value":"0.7","spread":"0.47"},{"groupId":"OG004","value":"0.4","spread":"0.28"}]}]}]},{"type":"SECONDARY","title":"Absolute Change in FPG From Baseline to End of Core Phase","description":"Absolute change in FPG from baseline to end of core phase in the incretin based therapy arm and the insulin arm.","populationDescription":"Full Analysis Set (FAS): All participants who received at least one dose of pasireotide. 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