Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-04 @ 12:43 PM
Study NCT ID:
NCT03345004
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2017-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Diamyd Administered Into Lymph Nodes in Combination With Vitamin D 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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@diamyd.com', 'phone': '+46 (0) 8 661 00 26', 'title': 'Director of Clinical Development', 'organization': 'Diamyd Medical AB'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events, from start of Diamyd/Placebo treatment until Month 24.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 18, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 12, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'seriousEvents': [{'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Diabetes Mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Stimulated C-peptide During a MMTT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.551', 'spread': '1.715', 'groupId': 'OG000'}, {'value': '0.506', 'spread': '2.163', 'groupId': 'OG001'}, {'value': '0.663', 'spread': '1.511', 'groupId': 'OG002'}, {'value': '0.425', 'spread': '2.436', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '= 0.5009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.091', 'ciLowerLimit': '0.845', 'ciUpperLimit': '1.408', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0078', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.557', 'ciLowerLimit': '1.126', 'ciUpperLimit': '2.153', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in C-peptide between Baseline and 15 Months. C-peptide was measured by Area Under the Curve \\[AUC\\] at 0-120 min during a Mixed Meal Tolerance Test (MMTT) and divided by 120 min. The results are given as the ratio (back-transformed from log-scale) between 15 Months and Baseline as predicted by the MMRM (Mixed Model Repeated Measures) model.', 'unitOfMeasure': 'Unitless back-transformed from log-scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. 1 patient in the active arm and 4 patients in the placebo arm were excluded due to lack of primary efficacy data at Visit 7.'}, {'type': 'SECONDARY', 'title': 'Change in IDAA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.757', 'spread': '1.851', 'groupId': 'OG000'}, {'value': '0.377', 'spread': '2.183', 'groupId': 'OG001'}, {'value': '0.663', 'spread': '1.627', 'groupId': 'OG002'}, {'value': '0.667', 'spread': '2.788', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in insulin-dose-adjusted HbA1c (IDAA1c)', 'unitOfMeasure': 'Percent of glycated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded.'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'spread': '14.57', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '15.87', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '14.34', 'groupId': 'OG002'}, {'value': '-0.98', 'spread': '18.75', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in HbA1c (mmol/mol)', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable.'}, {'type': 'SECONDARY', 'title': 'Change in Insulin Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.183', 'spread': '0.285', 'groupId': 'OG000'}, {'value': '0.094', 'spread': '0.342', 'groupId': 'OG001'}, {'value': '0.143', 'spread': '0.196', 'groupId': 'OG002'}, {'value': '0.153', 'spread': '0.399', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in daily exogenous insulin consumption (IU)', 'unitOfMeasure': 'IU/kg/24h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded.'}, {'type': 'SECONDARY', 'title': 'Change in Glycemic Variability/Fluctuations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'title': '70-180 mg/dL (hours)', 'categories': [{'measurements': [{'value': '-2.479', 'spread': '4.638', 'groupId': 'OG000'}, {'value': '-2.451', 'spread': '4.012', 'groupId': 'OG001'}, {'value': '-1.724', 'spread': '3.346', 'groupId': 'OG002'}, {'value': '-3.920', 'spread': '4.090', 'groupId': 'OG003'}]}]}, {'title': '50-70 mg/dL (hours)', 'categories': [{'measurements': [{'value': '-0.035', 'spread': '2.416', 'groupId': 'OG000'}, {'value': '0.197', 'spread': '1.961', 'groupId': 'OG001'}, {'value': '0.034', 'spread': '2.992', 'groupId': 'OG002'}, {'value': '0.581', 'spread': '1.057', 'groupId': 'OG003'}]}]}, {'title': '<50 mg/dL (minutes)', 'categories': [{'measurements': [{'value': '15.7', 'spread': '46.7', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '88.4', 'groupId': 'OG001'}, {'value': '16.7', 'spread': '59.3', 'groupId': 'OG002'}, {'value': '48.1', 'spread': '107.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and 15 months', 'description': 'Change in glycemic variability/fluctuations (evaluated from data from continuous glucose monitoring FreeStyle LibrePro, FGM) over 14 day period.', 'unitOfMeasure': 'glycemic variability/fluctuation per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With IDAA1c ≤ 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000', 'lowerLimit': '48.1', 'upperLimit': '75.9'}, {'value': '61.4', 'groupId': 'OG001', 'lowerLimit': '45.5', 'upperLimit': '75.6'}, {'value': '78.6', 'groupId': 'OG002', 'lowerLimit': '59.0', 'upperLimit': '91.7'}, {'value': '40.0', 'groupId': 'OG003', 'lowerLimit': '16.3', 'upperLimit': '67.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 months', 'description': 'Percentage of patients with IDAA1c ≤ 9', 'unitOfMeasure': 'Percent of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded.'}, {'type': 'SECONDARY', 'title': 'Stimulated Maximum C-peptide Above 0.2 Nmol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000', 'lowerLimit': '82.4', 'upperLimit': '98.0'}, {'value': '75.7', 'groupId': 'OG001', 'lowerLimit': '61.1', 'upperLimit': '86.7'}, {'value': '96.6', 'groupId': 'OG002', 'lowerLimit': '82.2', 'upperLimit': '99.9'}, {'value': '70.6', 'groupId': 'OG003', 'lowerLimit': '44.0', 'upperLimit': '89.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 months', 'description': 'Percentage of patients with a stimulated maximum C-peptide level above 0.2 nmol/L (0.6 ng/ml)', 'unitOfMeasure': 'Percent of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded.'}, {'type': 'SECONDARY', 'title': 'Stimulated C-peptide Above 0.2 Nmol/L at 90 Min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '75.5', 'upperLimit': '94.7'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '56.7', 'upperLimit': '83.4'}, {'value': '96.6', 'groupId': 'OG002', 'lowerLimit': '82.2', 'upperLimit': '99.9'}, {'value': '64.7', 'groupId': 'OG003', 'lowerLimit': '38.3', 'upperLimit': '85.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 months', 'description': 'Percentage of patients with a stimulated 90min C-peptide level above 0.2 nmol/L (0.6 ng/ml)', 'unitOfMeasure': 'Percent of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded.'}, {'type': 'SECONDARY', 'title': 'Number of Hypoglycemias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 15 months', 'description': 'Number of self-reported episodes of severe hypoglycemia (Severe hypoglycemia defined as needing help from others and/or seizures and/or unconscious) (counts)', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, consist of all randomized patients who received at leastone injection.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Having at Least 1 Severe Hypoglycemic Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 15 months', 'description': 'Number of patients having at least 1 severe hypoglycemic event (counts)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, consist of all randomized patients who received at leastone injection.'}, {'type': 'SECONDARY', 'title': 'Change in Maximum C-peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.350', 'spread': '0.463', 'groupId': 'OG000'}, {'value': '-0.300', 'spread': '0.350', 'groupId': 'OG001'}, {'value': '-0.257', 'spread': '0.400', 'groupId': 'OG002'}, {'value': '-0.277', 'spread': '0.349', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in maximum C-peptide during MMTT (nmol/L)', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting C-peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.115', 'spread': '0.148', 'groupId': 'OG000'}, {'value': '-0.106', 'spread': '0.169', 'groupId': 'OG001'}, {'value': '-0.081', 'spread': '0.100', 'groupId': 'OG002'}, {'value': '-0.095', 'spread': '0.190', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in Fasting C-peptide (nmol/L)', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded.'}, {'type': 'SECONDARY', 'title': 'C-peptide Levels During a MMTT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}, {'id': 'OG002', 'title': 'Active (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG003', 'title': 'Placebo (HLA DR3-DQ2)', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'title': '30 min', 'categories': [{'measurements': [{'value': '0.376', 'spread': '0.295', 'groupId': 'OG000'}, {'value': '0.374', 'spread': '0.330', 'groupId': 'OG001'}, {'value': '0.659', 'spread': '0.352', 'groupId': 'OG002'}, {'value': '0.580', 'spread': '0.282', 'groupId': 'OG003'}]}]}, {'title': '60 min', 'categories': [{'measurements': [{'value': '0.536', 'spread': '0.383', 'groupId': 'OG000'}, {'value': '0.495', 'spread': '0.411', 'groupId': 'OG001'}, {'value': '0.911', 'spread': '0.393', 'groupId': 'OG002'}, {'value': '0.715', 'spread': '0.308', 'groupId': 'OG003'}]}]}, {'title': '90 min', 'categories': [{'measurements': [{'value': '0.645', 'spread': '0.495', 'groupId': 'OG000'}, {'value': '0.562', 'spread': '0.438', 'groupId': 'OG001'}, {'value': '1.016', 'spread': '0.415', 'groupId': 'OG002'}, {'value': '0.717', 'spread': '0.318', 'groupId': 'OG003'}]}]}, {'title': '120 min', 'categories': [{'measurements': [{'value': '0.691', 'spread': '0.542', 'groupId': 'OG000'}, {'value': '0.590', 'spread': '0.444', 'groupId': 'OG001'}, {'value': '1.065', 'spread': '0.430', 'groupId': 'OG002'}, {'value': '0.728', 'spread': '0.317', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 months', 'description': 'C-peptide measured at 30, 60, 90, and 120 minutes during MMTT (nmol/L) at 15 months', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in body weight (kg)', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable.'}, {'type': 'SECONDARY', 'title': 'Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 months', 'description': 'Injection site reactions', 'unitOfMeasure': 'number of episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, consist of all randomized patients who received at leastone injection.'}, {'type': 'SECONDARY', 'title': 'Number of Clinically Significant Abnormal Results From Laboratory Measurements (Haematology and Clinical Chemistry) and Urinalysis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 months', 'description': 'Number of clinically significant abnormal results from laboratory measurements (haematology and clinical chemistry) and urinalysis. (counts)', 'unitOfMeasure': 'number of significant abnormal results', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, consist of all randomized patients who received at least one injection.'}, {'type': 'SECONDARY', 'title': 'Number of Clinically Significant Abnormal Results From Physical and Neurological Examinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'title': 'Physical examination', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Neurological examination', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 months', 'description': 'Physical examination (general appearance including skin, mouth, throat, cardiovascular, abdomen, lymphatic glands, and neurological/musculoskeletal \\[including reflexes\\]).\n\nStandardised clinical neurological examination including extremity reflexes, Romberg, Walk on a line, 2 meters, Standing on 1 leg, left and right, 15 seconds per leg, Finger-nose, Mimic, Babinski reflex.\n\nThe outcome of the assessments was recored as "normal" or "abnormal"', 'unitOfMeasure': 'Clinically significant abnormal results', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, consist of all randomized patients who received at leastone injection.'}, {'type': 'SECONDARY', 'title': 'GAD65A Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '731.3', 'spread': '2302.9', 'groupId': 'OG000'}, {'value': '627.3', 'spread': '1829.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 15', 'categories': [{'measurements': [{'value': '19941.2', 'spread': '23083.6', 'groupId': 'OG000'}, {'value': '476.7', 'spread': '1527.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'GAD65A titer (IU/ml)', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, consist of all randomized patients who received at leastone injection.'}, {'type': 'SECONDARY', 'title': 'Number of Clinically Significant Abnormal Results in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 months', 'description': 'Vital signs (blood pressure) (mmHg)', 'unitOfMeasure': 'Clinically significant abnormal results', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, consist of all randomized patients who received at leastone injection.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life (QoL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000', 'lowerLimit': '0.922', 'upperLimit': '1.000'}, {'value': '1.000', 'groupId': 'OG001', 'lowerLimit': '0.919', 'upperLimit': '1.000'}]}]}, {'title': 'Month 15', 'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000', 'lowerLimit': '0.919', 'upperLimit': '1.000'}, {'value': '1.000', 'groupId': 'OG001', 'lowerLimit': '1.000', 'upperLimit': '1.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in QoL as measured by the standardised measure of health questionnaire EQ-5D-5L between baseline and Month 15. The EQ-5D-5L is based on 5 questions rated at 5 levels indicating from no problem (level 1) to extreme problems (level 5) regarding current state of mobility, self-care, activity, pain and anxiety. The outcome is presented as a weighted index value, where 1 is the best possible health and 0 represents being dead.', 'unitOfMeasure': 'Index value', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded.'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in BMI (kg/m2)', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg recombinant human Glutamic Acid Decarboxylase adsorbed to Alhydrogel (Diamyd) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)'}, {'id': 'FG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'Haplotype DR3-DQ2 Population Month 15', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)\n\nGAD-alum: Alhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD)\n\nVitamin D: Oil suspension of Vitamin D'}, {'id': 'BG001', 'title': 'Placebo Arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)\n\nPlacebo for Diamyd (GAD-alum): Alhydrogel® only\n\nPlacebo for Vitamin D: Placebo oil suspension for Vitamin D'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '16.6', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '16.4', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-15', 'size': 1952713, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-23T04:23', 'hasProtocol': True}, {'date': '2020-06-23', 'size': 1432648, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-23T04:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2017-11-01', 'resultsFirstSubmitDate': '2021-11-23', 'studyFirstSubmitQcDate': '2017-11-13', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-11', 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Stimulated C-peptide During a MMTT', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in C-peptide between Baseline and 15 Months. C-peptide was measured by Area Under the Curve \\[AUC\\] at 0-120 min during a Mixed Meal Tolerance Test (MMTT) and divided by 120 min. The results are given as the ratio (back-transformed from log-scale) between 15 Months and Baseline as predicted by the MMRM (Mixed Model Repeated Measures) model.'}], 'secondaryOutcomes': [{'measure': 'Change in IDAA1c', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in insulin-dose-adjusted HbA1c (IDAA1c)'}, {'measure': 'Change in HbA1c', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in HbA1c (mmol/mol)'}, {'measure': 'Change in Insulin Consumption', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in daily exogenous insulin consumption (IU)'}, {'measure': 'Change in Glycemic Variability/Fluctuations', 'timeFrame': 'Screening and 15 months', 'description': 'Change in glycemic variability/fluctuations (evaluated from data from continuous glucose monitoring FreeStyle LibrePro, FGM) over 14 day period.'}, {'measure': 'Percentage of Patients With IDAA1c ≤ 9', 'timeFrame': '15 months', 'description': 'Percentage of patients with IDAA1c ≤ 9'}, {'measure': 'Stimulated Maximum C-peptide Above 0.2 Nmol/L', 'timeFrame': '15 months', 'description': 'Percentage of patients with a stimulated maximum C-peptide level above 0.2 nmol/L (0.6 ng/ml)'}, {'measure': 'Stimulated C-peptide Above 0.2 Nmol/L at 90 Min', 'timeFrame': '15 months', 'description': 'Percentage of patients with a stimulated 90min C-peptide level above 0.2 nmol/L (0.6 ng/ml)'}, {'measure': 'Number of Hypoglycemias', 'timeFrame': 'Baseline and 15 months', 'description': 'Number of self-reported episodes of severe hypoglycemia (Severe hypoglycemia defined as needing help from others and/or seizures and/or unconscious) (counts)'}, {'measure': 'Number of Patients Having at Least 1 Severe Hypoglycemic Event', 'timeFrame': 'Baseline and 15 months', 'description': 'Number of patients having at least 1 severe hypoglycemic event (counts)'}, {'measure': 'Change in Maximum C-peptide', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in maximum C-peptide during MMTT (nmol/L)'}, {'measure': 'Change in Fasting C-peptide', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in Fasting C-peptide (nmol/L)'}, {'measure': 'C-peptide Levels During a MMTT', 'timeFrame': '15 months', 'description': 'C-peptide measured at 30, 60, 90, and 120 minutes during MMTT (nmol/L) at 15 months'}, {'measure': 'Change in Body Weight', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in body weight (kg)'}, {'measure': 'Injection Site Reactions', 'timeFrame': '15 months', 'description': 'Injection site reactions'}, {'measure': 'Number of Clinically Significant Abnormal Results From Laboratory Measurements (Haematology and Clinical Chemistry) and Urinalysis.', 'timeFrame': '15 months', 'description': 'Number of clinically significant abnormal results from laboratory measurements (haematology and clinical chemistry) and urinalysis. (counts)'}, {'measure': 'Number of Clinically Significant Abnormal Results From Physical and Neurological Examinations', 'timeFrame': '15 months', 'description': 'Physical examination (general appearance including skin, mouth, throat, cardiovascular, abdomen, lymphatic glands, and neurological/musculoskeletal \\[including reflexes\\]).\n\nStandardised clinical neurological examination including extremity reflexes, Romberg, Walk on a line, 2 meters, Standing on 1 leg, left and right, 15 seconds per leg, Finger-nose, Mimic, Babinski reflex.\n\nThe outcome of the assessments was recored as "normal" or "abnormal"'}, {'measure': 'GAD65A Titer', 'timeFrame': 'Baseline and 15 months', 'description': 'GAD65A titer (IU/ml)'}, {'measure': 'Number of Clinically Significant Abnormal Results in Vital Signs', 'timeFrame': '15 months', 'description': 'Vital signs (blood pressure) (mmHg)'}, {'measure': 'Change in Quality of Life (QoL)', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in QoL as measured by the standardised measure of health questionnaire EQ-5D-5L between baseline and Month 15. The EQ-5D-5L is based on 5 questions rated at 5 levels indicating from no problem (level 1) to extreme problems (level 5) regarding current state of mobility, self-care, activity, pain and anxiety. The outcome is presented as a weighted index value, where 1 is the best possible health and 0 represents being dead.'}, {'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': 'Baseline and 15 months', 'description': 'Change in BMI (kg/m2)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diamyd', 'Diabetes', 'Juvenile Diabetes', 'Diabetes Type 1', 'Type 1 Diabetes', 'Autoimmune Diabetes', 'Insulin Dependent Diabetes', 'Type 1 Diabetes Mellitus', 'rhGAD65', 'GAD65', 'Diabetes Mellitus', 'Diabetes Mellitus Type 1', 'Glucose Metabolism Disorders', 'Metabolic Diseases', 'Vitamin D', 'Vitamins', 'Micronutrients', 'Cholecalciferol', 'Ergocalciferols'], 'conditions': ['Diabetes Mellitus, Type 1', 'Diabetes Mellitus', 'Autoimmune Diseases', 'Metabolic Disease', 'Glucose Metabolism Disorders', 'Immune System Diseases', 'Endocrine System Diseases', 'Juvenile Diabetes', 'Insulin Dependent Diabetes', 'Autoimmune Diabetes', 'Vitamin D', 'Physiological Effects of Drugs']}, 'referencesModule': {'references': [{'pmid': '28199812', 'type': 'BACKGROUND', 'citation': 'Ludvigsson J, Wahlberg J, Casas R. Intralymphatic Injection of Autoantigen in Type 1 Diabetes. N Engl J Med. 2017 Feb 16;376(7):697-699. doi: 10.1056/NEJMc1616343. No abstract available.'}, {'pmid': '28745988', 'type': 'BACKGROUND', 'citation': 'Ludvigsson J, Tavira B, Casas R. More on Intralymphatic Injection of Autoantigen in Type 1 Diabetes. N Engl J Med. 2017 Jul 27;377(4):403-5. doi: 10.1056/NEJMc1703468. No abstract available.'}, {'pmid': '36817467', 'type': 'DERIVED', 'citation': 'Puente-Marin S, Dietrich F, Achenbach P, Barcenilla H, Ludvigsson J, Casas R. Intralymphatic glutamic acid decarboxylase administration in type 1 diabetes patients induced a distinctive early immune response in patients with DR3DQ2 haplotype. Front Immunol. 2023 Feb 2;14:1112570. doi: 10.3389/fimmu.2023.1112570. eCollection 2023.'}, {'pmid': '35665810', 'type': 'DERIVED', 'citation': 'Nowak C, Lind M, Sumnik Z, Pelikanova T, Nattero-Chavez L, Lundberg E, Rica I, Martinez-Brocca MA, Ruiz de Adana M, Wahlberg J, Hanas R, Hernandez C, Clemente-Leon M, Gomez-Gila A, Ferrer Lozano M, Sas T, Pruhova S, Dietrich F, Puente-Marin S, Hannelius U, Casas R, Ludvigsson J. Intralymphatic GAD-Alum (Diamyd(R)) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2. J Clin Endocrinol Metab. 2022 Aug 18;107(9):2644-2651. doi: 10.1210/clinem/dgac343.'}, {'pmid': '34021020', 'type': 'DERIVED', 'citation': 'Ludvigsson J, Sumnik Z, Pelikanova T, Nattero Chavez L, Lundberg E, Rica I, Martinez-Brocca MA, Ruiz de Adana M, Wahlberg J, Katsarou A, Hanas R, Hernandez C, Clemente Leon M, Gomez-Gila A, Lind M, Lozano MF, Sas T, Samuelsson U, Pruhova S, Dietrich F, Puente Marin S, Nordlund A, Hannelius U, Casas R. Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial. Diabetes Care. 2021 Jul;44(7):1604-1612. doi: 10.2337/dc21-0318. Epub 2021 May 21.'}], 'seeAlsoLinks': [{'url': 'http://www.diagnode-2.com', 'label': 'Information regarding the clinical trial'}]}, 'descriptionModule': {'briefSummary': 'The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide.', 'detailedDescription': 'The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial. Eligible patients will receive injections of Diamyd/placebo into an inguinal lymph gland at three occasions, with one month intervals in combination with an oral vitamin D/placebo regimen (starting 1 month ahead of injections) during 4 months. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period. The patients will be followed in a blinded manner for a total of 15 months. All patients that have not performed the 15 months visit when the updated protocol is implemented, will be asked to participate in the Extension Study Period which includes an additional visit at month 24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Informed consent given by patients and/or patient's parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations\n2. Type 1 Diabetes (T1D) according to the Amercian Diabetes Association (ADA) classification diagnosed ≤6 months at the time of screening\n3. Age: ≥12 and \\<25 years old\n4. Fasting C-peptide ≥0.12 nmol/L (0.36 ng/ml) on at least one occasion (maximum 2 tests on different days within a period of 2 weeks)\n5. Positive for Glutamic Acid Decarboxylase isoform 65 (GAD65A) but \\< 50 000 IU/ml\n6. Females must agree to avoid pregnancy and have a negative urine pregnancy test. Patients of childbearing potential must agree to use adequate contraception, until one (1) year after the last administration of Diamyd. Adequate contraception is as follows:\n\nFor females of childbearing potential:\n\n1. oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives\n2. combined (estrogen and progestogen containing)\n3. oral, intravaginal or transdermal progesterone hormonal contraception associated with inhibition of ovulation\n4. intrauterine device\n5. intrauterine hormone-releasing system (for example, progestin-releasing coil)\n6. bilateral tubal occlusion\n7. vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)\n8. male partner using condom\n9. abstinence from heterosexual intercourse\n\nFor males of childbearing potential:\n\n1. condom (male)\n2. abstinence from heterosexual intercourse\n\nExclusion Criteria:\n\n1. Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)\n2. Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)\n3. Treatment with any oral or injected anti-diabetic medications other than insulin\n4. A history of anemia or significantly abnormal hematology results at screening\n5. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles\n6. Clinically significant history of acute reaction to vaccines or other drugs in the past\n7. Treatment with any vaccine, including influenza vaccine, within 4 months prior to planned first study drug dose or planned treatment with any vaccine up to 4 months after the last injection with study drug.\n8. Participation in other clinical trials with a new chemical entity within the previous 3 months\n9. Inability or unwillingness to comply with the provisions of this protocol\n10. A history of alcohol or drug abuse\n11. A significant illness other than diabetes within 2 weeks prior to first dosing\n12. Known HIV or hepatitis\n13. Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior to the Diamyd/placebo treatment)\n14. Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study\n15. Deemed by the investigator not being able to follow instructions and/or follow the study protocol"}, 'identificationModule': {'nctId': 'NCT03345004', 'briefTitle': 'Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Diamyd Medical AB'}, 'officialTitle': 'A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd Therapy Administered Into Lymph Nodes Combined With Oral Vitamin D to Investigate the Impact on the Progression of Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'DIAGNODE-2 (D/P2/17/6)'}, 'secondaryIdInfos': [{'id': '2017-001861-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with Recombinant human Glutamic Acid Decarboxylase adsorbed to Alhydrogel (Diamyd) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)', 'interventionNames': ['Biological: Diamyd', 'Dietary Supplement: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)', 'interventionNames': ['Biological: Placebo for Diamyd', 'Dietary Supplement: Placebo for Vitamin D']}], 'interventions': [{'name': 'Diamyd', 'type': 'BIOLOGICAL', 'otherNames': ['GAD-alum'], 'description': 'Alhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD65)', 'armGroupLabels': ['Active arm']}, {'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oil suspension of Vitamin D', 'armGroupLabels': ['Active arm']}, {'name': 'Placebo for Diamyd', 'type': 'BIOLOGICAL', 'description': 'Alhydrogel® only', 'armGroupLabels': ['Placebo arm']}, {'name': 'Placebo for Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo oil suspension for Vitamin D', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14021', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Diabetes Centre, Institute of Clinical and Experimental Medicine', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '15006', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Department of Paediatrics, University Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '3011 TA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Diabeter Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '48903', 'city': 'Barakaldo', 'country': 'Spain', 'facility': 'Adult and Pediatrics Endocrinology and Diabetology, Hospital Universitario Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Adult Endocrinology and Diabetology, Hospital vall D' Hebrón", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Pediatrics Endocrinology and Diabetology, Hospital Vall D'Hebrón", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28033', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Adult Endocrinology and Diabetology, Hospital Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29009', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Adult Endocrinology and Diabetology, Hospital Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '29011', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Pediatrics Endocrinology and Diabetology, Hospital Materno-Ifantil', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Adult Endocrinology and Diabetology, Hospital Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Pediatrics Endocrinology and Diabetology, Hospital Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Adult and Pediatrics Endocrinology and Diabetology, Hospital Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '58185', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Barn- och Ungdomskliniken, Universitetssjukhuset', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '58185', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Endokrinmedicinska kliniken. Universitetssjukhuset', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '20502', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Barn-och Ungdomsmedicinmottagningen and Endokrinmottagningen, Skånes Universitetssjukhus', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '45180', 'city': 'Uddevalla', 'country': 'Sweden', 'facility': 'Barn- och ungdomskliniken, Uddevalla Sjukhus', 'geoPoint': {'lat': 58.34784, 'lon': 11.9424}}, {'zip': '45180', 'city': 'Uddevalla', 'country': 'Sweden', 'facility': 'Diabetesmottagningen, Uddevalla Sjukhus', 'geoPoint': {'lat': 58.34784, 'lon': 11.9424}}, {'zip': '901 85', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Barnmottagningen, Norrlands Universitetssjukhus', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Johnny Ludvigsson, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitetssjukhuset i Linköping'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diamyd Medical AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}