Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 9:50 PM
Study NCT ID:
NCT05537233
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2022-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ADJUnct Semaglutide Treatment in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shahvi@iu.edu', 'phone': '317-278-6017', 'title': 'Viral N Shah, MD', 'organization': 'Indiana University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'from signing consent from till end of the study (i.e 26 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 26, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 11, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastrointestinal events', 'notes': 'GI event: nausea, vomiting, reflux (gastrointestinal reflux disease), burping or belching, diarrhea, constipation, loss of appetite, and elevated levels of liver enzymes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 57, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respitory infectin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Nausea & vomiting', 'notes': 'Severe GI event leading to hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Adults With T1D Achieving Composite Outcome (CGM-measured Time in Range (TIR)>70% With Time Below Range (TBR) of <4% and Reduction in Body Weight by 5%) at 26 Weeks in the Semaglutide Group Compared to Placebo Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '26 weeks', 'description': 'Primary outcome will be analyzed per statistical analysis plan using intention to treat basis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'HbA1c will be measured at a central laboratory and change in Hba1c from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.', 'unitOfMeasure': 'percentage HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Mean Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Mean glucose (mg/dL) will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Percent of time spent in tight glucose range (70-140 mg/dL) will be obtained by CGM and change in percent time in range from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Time Spent in CGM-measured Glucose >180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Percent of time spent in glucose range \\>180 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Time Spent in CGM-measured Glucose >250mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Percent of time spent in glucose range \\>250 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Time Spent in CGM-measured Glucose <70mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Percent of time spent in glucose range \\<70 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in CGM Measured Glycemic Variability (Coefficient of Variation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Glucose coefficient of variation (mg/dL) will be obtained by CGM and change in glucose CV from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'The change in kg of body weight from baseline to 26 weeks will be compared by randomization group using an ITT analysis.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BMI (Kg/m2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Change in body mass index (BMI) calculated as kg body weight per meter squared of height from baseline to 26 weeks will be compared by randomization group using an ITT analysis.', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severe Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '26 weeks', 'description': 'SH events in number of patients per group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Patient Reported Quality of Life', 'timeFrame': '26 weeks', 'description': 'Patient reported quality of life will be measured using a validated instrument (ADDQOL) and the change in score from baseline to 26 weeks will be compared by randomization group using an ITT analysis.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-07'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Participants With HbA1c <7%', 'timeFrame': '26 weeks', 'description': 'proportion (N, %) of participants achieving HbA1c \\<7% between two groups over 26 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Participants With HbA1c <7.5%', 'timeFrame': '26 weeks', 'description': 'proportion (N, %) of participants achieving HbA1c \\<7.5% between two groups over 26 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HbA1c Improvement', 'timeFrame': '26 weeks', 'description': 'HbA1c improvement from baseline to 26 weeks between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HbA1c Improvement of >0.4% From Baseline', 'timeFrame': '26 weeks', 'description': 'proportion of participants with HbA1c improvement of \\>0.4% from baseline between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Participants Achieving TIR >70%', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving TIR \\>70% between two groups over 26 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Participants Achieving TITR >50%', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving TITR (time in 70-140 mg/dL) \\>50% between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Participants Achieving TIR >80%', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving TIR \\>80% between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Participants Achieving TITR >60%', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving TITR (time in 70-140 mg/dL) \\>60% between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of TBR<70 Events', 'timeFrame': '26 weeks', 'description': 'Numbers of events of CGM glucose \\<70 mg/dL lasting for at least 15 minutes between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of TBR <54 Events', 'timeFrame': '26 weeks', 'description': 'Numbers of events of CGM glucose \\<54mg/dL lasting for at least 15 minutes between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Total Daily Dose of Insulin (TDD, Units Per Day and U/Kg/Day)', 'timeFrame': '26 weeks', 'description': 'Change in TDD between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion Achieving Weight Loss ≥5%', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving weight loss ≥5% from baseline between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion Achieving Weight Loss ≥10%', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving weight loss ≥10% from baseline between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Achieving BMI <30 kg/m2', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving BMI \\<30 kg/m2 between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Achieving BMI <25 kg/m2', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving BMI \\<25 kg/m2 between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Systolic Blood Pressure (SBP)', 'timeFrame': '26 weeks', 'description': 'change in SBP (mmHg) between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Diastolic Blood Pressure (DBP)', 'timeFrame': '26 weeks', 'description': 'change in DBP (mmHg) between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Pulse Pressure', 'timeFrame': '26 weeks', 'description': 'change in pulse pressure between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Triglyceride/HDL Ratio', 'timeFrame': '26 weeks', 'description': 'Change in triglyceride/HDL ratio between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Brach D', 'timeFrame': '26 weeks', 'description': 'Change in brachial arterial distensibility between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Carotid Intima Media Thickness (cIMT)', 'timeFrame': '26 weeks', 'description': 'Change in carotid intima media thickness (cIMT) between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Femoral to Carotid Pulse Wave Velocity (m/s)', 'timeFrame': '26 weeks', 'description': 'Change in femoral to carotid pulse wave velocity (m/s) between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Urine Albumin to Creatinine Ratio (ACR)', 'timeFrame': '26 weeks', 'description': 'Change in ACR between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life (Diabetes Dependent QOL)', 'timeFrame': '26 weeks', 'description': 'Change in QOL between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in CGM Metrics by Daytime vs Nighttime', 'timeFrame': '26 weeks', 'description': 'Change in CGM metrics (TIR, TITR, mean glucose, TBR, TAR \\>180, SD, CV) by daytime (6 AM to \\<11 PM) and nighttime (11 PM to \\<6 AM) between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'AID Setting Adjustment', 'timeFrame': '26 weeks', 'description': 'Defined any adjustment in settings by provider or patient per person over the study period by two groups (number of adjustments (N) during trial) between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Basal Insulin Per Day', 'timeFrame': '26 weeks', 'description': 'Change in basal insulin per day (Total basal insulin including autobasal delivery, units per day and U/kg/day) between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Total Boluses Per Day', 'timeFrame': '26 weeks', 'description': 'Change in total boluses per day (frequency of boluses per day) between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Achievement of Primary Outcome and Key Secondary Outcomes by Types of AID Systems', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving primary outcome and key secondary glycemic outcomes by types of AID systems', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Carbohydrate Intake Per Day (Grams/Day)', 'timeFrame': '26 weeks', 'description': 'Change in Carbohydrate intake per day (grams/day) between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Total Bolus Insulin Per Day', 'timeFrame': '26 weeks', 'description': 'Change in total bolus insulin per day (units per day and U/Kg/day) between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in eGFR', 'timeFrame': '26 weeks', 'description': 'Change in eGFR using CKD-EPI between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Fib-4 Score', 'timeFrame': '26 weeks', 'description': 'Change in Fib-4 score between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in HSI (Hepatic Steatosis Index)', 'timeFrame': '26 weeks', 'description': 'Change in HSI (hepatic steatosis index) between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in MRI Measured Pulse Wave Velocity and Longitudinal Strain', 'timeFrame': '26 weeks', 'description': 'Change in MRI measured pulse wave velocity and longitudinal strain between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in LDL-C', 'timeFrame': '26 weeks', 'description': 'Change in LDL-C between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in TC', 'timeFrame': '26 weeks', 'description': 'Change in TC between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in TG', 'timeFrame': '26 weeks', 'description': 'Change in TG between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in HDL-C', 'timeFrame': '26 weeks', 'description': 'Change in HDL-C between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion With ACR <30 at 26 Weeks', 'timeFrame': '26 weeks', 'description': 'Proportion of participants with ACR \\<30 at 26 weeks between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion With Change in ACR From >30 to <30', 'timeFrame': '26 weeks', 'description': 'Proportion of participants with change in ACR from \\>30 to \\<30 between two groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Achievement of Primary Outcomes by Baseline BMI (BMI <35 vs >35)', 'timeFrame': '26 weeks', 'description': 'Achievement of primary outcomes by baseline BMI (BMI \\<35 vs \\>35)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Achievement of Primary Outcomes by Baseline A1c (A1c <7.5% vs >7.5%)', 'timeFrame': '26 weeks', 'description': 'Achievement of primary outcomes by baseline A1c (A1c \\<7.5% vs \\>7.5%)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy\n\nSemaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy\n\nPlacebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '38.9', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '40', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'body mass index', 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '36.0', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '35', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '7.7', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '7.8', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes Duration', 'classes': [{'categories': [{'measurements': [{'value': '23.4', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '21.9', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '23', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-30', 'size': 656429, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-27T18:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2022-08-23', 'resultsFirstSubmitDate': '2025-07-27', 'studyFirstSubmitQcDate': '2022-09-08', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-07-27', 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Patient Reported Quality of Life', 'timeFrame': '26 weeks', 'description': 'Patient reported quality of life will be measured using a validated instrument (ADDQOL) and the change in score from baseline to 26 weeks will be compared by randomization group using an ITT analysis.'}, {'measure': 'Proportion of Participants With HbA1c <7%', 'timeFrame': '26 weeks', 'description': 'proportion (N, %) of participants achieving HbA1c \\<7% between two groups over 26 weeks'}, {'measure': 'Proportion of Participants With HbA1c <7.5%', 'timeFrame': '26 weeks', 'description': 'proportion (N, %) of participants achieving HbA1c \\<7.5% between two groups over 26 weeks'}, {'measure': 'HbA1c Improvement', 'timeFrame': '26 weeks', 'description': 'HbA1c improvement from baseline to 26 weeks between two groups'}, {'measure': 'HbA1c Improvement of >0.4% From Baseline', 'timeFrame': '26 weeks', 'description': 'proportion of participants with HbA1c improvement of \\>0.4% from baseline between two groups'}, {'measure': 'Proportion of Participants Achieving TIR >70%', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving TIR \\>70% between two groups over 26 weeks'}, {'measure': 'Proportion of Participants Achieving TITR >50%', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving TITR (time in 70-140 mg/dL) \\>50% between two groups'}, {'measure': 'Proportion of Participants Achieving TIR >80%', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving TIR \\>80% between two groups'}, {'measure': 'Proportion of Participants Achieving TITR >60%', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving TITR (time in 70-140 mg/dL) \\>60% between two groups'}, {'measure': 'Number of TBR<70 Events', 'timeFrame': '26 weeks', 'description': 'Numbers of events of CGM glucose \\<70 mg/dL lasting for at least 15 minutes between two groups'}, {'measure': 'Number of TBR <54 Events', 'timeFrame': '26 weeks', 'description': 'Numbers of events of CGM glucose \\<54mg/dL lasting for at least 15 minutes between two groups'}, {'measure': 'Change in Total Daily Dose of Insulin (TDD, Units Per Day and U/Kg/Day)', 'timeFrame': '26 weeks', 'description': 'Change in TDD between two groups'}, {'measure': 'Proportion Achieving Weight Loss ≥5%', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving weight loss ≥5% from baseline between two groups'}, {'measure': 'Proportion Achieving Weight Loss ≥10%', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving weight loss ≥10% from baseline between two groups'}, {'measure': 'Proportion of Achieving BMI <30 kg/m2', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving BMI \\<30 kg/m2 between two groups'}, {'measure': 'Proportion of Achieving BMI <25 kg/m2', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving BMI \\<25 kg/m2 between two groups'}, {'measure': 'Change in Systolic Blood Pressure (SBP)', 'timeFrame': '26 weeks', 'description': 'change in SBP (mmHg) between two groups'}, {'measure': 'Change in Diastolic Blood Pressure (DBP)', 'timeFrame': '26 weeks', 'description': 'change in DBP (mmHg) between two groups'}, {'measure': 'Change in Pulse Pressure', 'timeFrame': '26 weeks', 'description': 'change in pulse pressure between two groups'}, {'measure': 'Change in Triglyceride/HDL Ratio', 'timeFrame': '26 weeks', 'description': 'Change in triglyceride/HDL ratio between two groups'}, {'measure': 'Change in Brach D', 'timeFrame': '26 weeks', 'description': 'Change in brachial arterial distensibility between two groups'}, {'measure': 'Change in Carotid Intima Media Thickness (cIMT)', 'timeFrame': '26 weeks', 'description': 'Change in carotid intima media thickness (cIMT) between two groups'}, {'measure': 'Change in Femoral to Carotid Pulse Wave Velocity (m/s)', 'timeFrame': '26 weeks', 'description': 'Change in femoral to carotid pulse wave velocity (m/s) between two groups'}, {'measure': 'Change in Urine Albumin to Creatinine Ratio (ACR)', 'timeFrame': '26 weeks', 'description': 'Change in ACR between two groups'}, {'measure': 'Quality of Life (Diabetes Dependent QOL)', 'timeFrame': '26 weeks', 'description': 'Change in QOL between two groups'}, {'measure': 'Change in CGM Metrics by Daytime vs Nighttime', 'timeFrame': '26 weeks', 'description': 'Change in CGM metrics (TIR, TITR, mean glucose, TBR, TAR \\>180, SD, CV) by daytime (6 AM to \\<11 PM) and nighttime (11 PM to \\<6 AM) between two groups'}, {'measure': 'AID Setting Adjustment', 'timeFrame': '26 weeks', 'description': 'Defined any adjustment in settings by provider or patient per person over the study period by two groups (number of adjustments (N) during trial) between two groups'}, {'measure': 'Change in Basal Insulin Per Day', 'timeFrame': '26 weeks', 'description': 'Change in basal insulin per day (Total basal insulin including autobasal delivery, units per day and U/kg/day) between two groups'}, {'measure': 'Change in Total Boluses Per Day', 'timeFrame': '26 weeks', 'description': 'Change in total boluses per day (frequency of boluses per day) between two groups'}, {'measure': 'Achievement of Primary Outcome and Key Secondary Outcomes by Types of AID Systems', 'timeFrame': '26 weeks', 'description': 'Proportion of participants achieving primary outcome and key secondary glycemic outcomes by types of AID systems'}, {'measure': 'Change in Carbohydrate Intake Per Day (Grams/Day)', 'timeFrame': '26 weeks', 'description': 'Change in Carbohydrate intake per day (grams/day) between two groups'}, {'measure': 'Change in Total Bolus Insulin Per Day', 'timeFrame': '26 weeks', 'description': 'Change in total bolus insulin per day (units per day and U/Kg/day) between two groups'}, {'measure': 'Change in eGFR', 'timeFrame': '26 weeks', 'description': 'Change in eGFR using CKD-EPI between two groups'}, {'measure': 'Change in Fib-4 Score', 'timeFrame': '26 weeks', 'description': 'Change in Fib-4 score between two groups'}, {'measure': 'Change in HSI (Hepatic Steatosis Index)', 'timeFrame': '26 weeks', 'description': 'Change in HSI (hepatic steatosis index) between two groups'}, {'measure': 'Change in MRI Measured Pulse Wave Velocity and Longitudinal Strain', 'timeFrame': '26 weeks', 'description': 'Change in MRI measured pulse wave velocity and longitudinal strain between two groups'}, {'measure': 'Change in LDL-C', 'timeFrame': '26 weeks', 'description': 'Change in LDL-C between two groups'}, {'measure': 'Change in TC', 'timeFrame': '26 weeks', 'description': 'Change in TC between two groups'}, {'measure': 'Change in TG', 'timeFrame': '26 weeks', 'description': 'Change in TG between two groups'}, {'measure': 'Change in HDL-C', 'timeFrame': '26 weeks', 'description': 'Change in HDL-C between two groups'}, {'measure': 'Proportion With ACR <30 at 26 Weeks', 'timeFrame': '26 weeks', 'description': 'Proportion of participants with ACR \\<30 at 26 weeks between two groups'}, {'measure': 'Proportion With Change in ACR From >30 to <30', 'timeFrame': '26 weeks', 'description': 'Proportion of participants with change in ACR from \\>30 to \\<30 between two groups'}, {'measure': 'Achievement of Primary Outcomes by Baseline BMI (BMI <35 vs >35)', 'timeFrame': '26 weeks', 'description': 'Achievement of primary outcomes by baseline BMI (BMI \\<35 vs \\>35)'}, {'measure': 'Achievement of Primary Outcomes by Baseline A1c (A1c <7.5% vs >7.5%)', 'timeFrame': '26 weeks', 'description': 'Achievement of primary outcomes by baseline A1c (A1c \\<7.5% vs \\>7.5%)'}], 'primaryOutcomes': [{'measure': 'Proportion of Adults With T1D Achieving Composite Outcome (CGM-measured Time in Range (TIR)>70% With Time Below Range (TBR) of <4% and Reduction in Body Weight by 5%) at 26 Weeks in the Semaglutide Group Compared to Placebo Group', 'timeFrame': '26 weeks', 'description': 'Primary outcome will be analyzed per statistical analysis plan using intention to treat basis.'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': '26 weeks', 'description': 'HbA1c will be measured at a central laboratory and change in Hba1c from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.'}, {'measure': 'Change in Mean Glucose', 'timeFrame': '26 weeks', 'description': 'Mean glucose (mg/dL) will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.'}, {'measure': 'Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR)', 'timeFrame': '26 weeks', 'description': 'Percent of time spent in tight glucose range (70-140 mg/dL) will be obtained by CGM and change in percent time in range from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.'}, {'measure': 'Percent Time Spent in CGM-measured Glucose >180 mg/dL', 'timeFrame': '26 weeks', 'description': 'Percent of time spent in glucose range \\>180 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.'}, {'measure': 'Percent Time Spent in CGM-measured Glucose >250mg/dL', 'timeFrame': '26 weeks', 'description': 'Percent of time spent in glucose range \\>250 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.'}, {'measure': 'Percent Time Spent in CGM-measured Glucose <70mg/dL', 'timeFrame': '26 weeks', 'description': 'Percent of time spent in glucose range \\<70 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.'}, {'measure': 'Change in CGM Measured Glycemic Variability (Coefficient of Variation)', 'timeFrame': '26 weeks', 'description': 'Glucose coefficient of variation (mg/dL) will be obtained by CGM and change in glucose CV from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.'}, {'measure': 'Change in Weight', 'timeFrame': '26 weeks', 'description': 'The change in kg of body weight from baseline to 26 weeks will be compared by randomization group using an ITT analysis.'}, {'measure': 'Change in BMI (Kg/m2)', 'timeFrame': '26 weeks', 'description': 'Change in body mass index (BMI) calculated as kg body weight per meter squared of height from baseline to 26 weeks will be compared by randomization group using an ITT analysis.'}, {'measure': 'Severe Hypoglycemia', 'timeFrame': '26 weeks', 'description': 'SH events in number of patients per group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 diabetes', 'Obesity', 'HbA1c', 'Time-in-range', 'Weight loss', 'Cardiovascular risk'], 'conditions': ['Type 1 Diabetes', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '40550013', 'type': 'DERIVED', 'citation': 'Shah VN, Akturk HK, Kruger D, Ahmann A, Bhargava A, Bakoyannis G, Pyle L, Snell-Bergeon JK. Semaglutide in Adults with Type 1 Diabetes and Obesity. NEJM Evid. 2025 Aug;4(8):EVIDoa2500173. doi: 10.1056/EVIDoa2500173. Epub 2025 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the use of once weekly semaglutide injection in inadequately controlled obese adults with type 1 diabetes (T1D) using FDA-approved hybrid closed-loop therapies.', 'detailedDescription': 'After being informed about the study and potential risks, all patients given written informed consent will undergo a 2-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner using computer generated randomization scheme to receive either semaglutide or placebo (1:1 ratio) for 26 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor an eligible subject, all inclusion criteria must be answered "yes"\n\n1. Age ≥18 and ≤ 65 years\n2. Patients with clinical diagnosis of T1D diagnosed for at least 12 months\n3. Patient is on FDA- approved hybrid closed-loop system for ≥ 3 months\n4. Willing to use once weekly semaglutide\n5. Willing to share devices (HCL system) data uploads\n6. HbA1c \\>7.0% and \\<10.0%\n7. Body mass index ≥30 kg/m2\n8. Has current glucagon product to treat severe hypoglycemia\n9. Has current ketone meters to check ketones\n10. Ability to provide informed consent before any trial-related activities\n\nExclusion Criteria:\n\n1. Age \\<18 years and \\>65 years\n2. HbA1c ≤7.0 % or ≥ 10.0% at screening\n3. Less than 12 months of insulin treatment\n4. Use of unapproved insulin for HCL system. E.g. use of Fiasp in the Tandem Control-IQ system\n5. Not willing to share the devices (HCL system) data uploads\n6. Non compatible devices (e.g. pump, CGM or smart phones) for data transfer\n7. Current use of multiple daily injection or inhaled insulin (Afrezza)\n8. Patients with T1D using any glucose lowering medications other than insulin at the time of screening\n9. Pregnancy, breast feeding, and positive pregnancy test during screening\n10. Women of childbearing age wanting to become pregnant\n11. Unwilling to use acceptable contraceptive methods (for both men and women) during the trial period\n12. Current use (≥ 2 weeks of continuous use) of any steroidal medication, or anticipated long-term steroidal treatment (\\>4 weeks continuously), during the study period\n13. Use of GLP-1RA or weight loss medications in the past 3 month\n14. Clinical diagnosis/history of gastroparesis or gastric motility disorders\n15. Serum triglycerides \\>500 mg/dL\n16. Planning for bariatric surgery during the study period\n17. eGFR below 45 ml/min/1.73 m\\^2 using CKD-EPI formula\n18. History of severe hypoglycemia in the previous 3 months\n19. History of diabetic ketoacidosis requiring hospitalization in the past 3 months\n20. History of allergy to any form of insulin, GLP-1RA or its excipients\n21. History of any form of pancreatitis\n22. History of stroke, myocardial infarction in the past 3 months\n23. History of congestive heart failure class III or IV\n24. History of acute or chronic liver disease\n25. History of malignancy requiring chemotherapy, surgery or radiation in previous 5 years\n26. Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) or familial thyroid carcinoma or non-familial medullary thyroid carcinoma\n27. Have a pacemaker, metal implants, or aneurysm clips or weigh \\>330 lbs (exclusion only if doing MRI)\n28. Use of investigational drugs within 5 half-lives prior to screening\n29. Participation to other intervention trials during the study period\n30. Any comorbidities or medical conditions such as severe psychiatric disorder that make a person unfit for the study at the discretion of the investigators'}, 'identificationModule': {'nctId': 'NCT05537233', 'acronym': 'ADJUST-T1D', 'briefTitle': 'ADJUnct Semaglutide Treatment in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Efficacy and Safety of Once Weekly Semaglutide in Adults With Obesity and Inadequately Controlled Type 1 Diabetes Using Hybrid Closed-Loop System.', 'orgStudyIdInfo': {'id': '22388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide', 'description': 'Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy', 'interventionNames': ['Drug: Semaglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Semaglutide up to 1 mg per week in addition to standard closed-loop therapy', 'armGroupLabels': ['Semaglutide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Injection placebo up to 1 mg per week in addition to standard closed-loop therapy', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center for Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '50265', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Diabetes Research Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Harold Schnitzer Diabetes Health Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Viral N Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD may be available once the study is completed and all results are published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viral N. Shah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Division of Endocrinology & Metabolism', 'investigatorFullName': 'Viral N. Shah', 'investigatorAffiliation': 'Indiana University'}}}}