Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-30 @ 3:34 PM
Study NCT ID:
NCT02464033
Status:
COMPLETED
Last Update Posted:
2021-03-29
First Post:
2015-05-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EDCR Study - Etanercept Diamyd Combination Regimen -Open Trial to Evaluate Safety in Children With 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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Johnny.Ludvigsson@liu.se', 'phone': '+46 13 28 68 54', 'title': 'Johnny Ludvigsson, MD, PhD, Prof Linkoeping University', 'organization': 'Linkoeping University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 months', 'description': 'Adverse Events were recorded in the Case Report Form at each clinic visit.', 'eventGroups': [{'id': 'EG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 30, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 15, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 20, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 months', 'description': 'Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months', 'description': 'Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 1, 2, 3, 6, 9, 15 and 30', 'description': 'Number of patients with any abnormal findings from physical examinations after baseline, including neurological assessments as an assessment of tolerability.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Clinically Significant Laboratory Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 1, 2, 3, 6, 9, 15 and 30', 'description': 'Number of patients with clinically significant laboratory findings, laboratory measurements as an assessment of the tolerability', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety'}, {'type': 'PRIMARY', 'title': 'GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '2509.41', 'spread': '4866.515', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000', 'unitOfMeasure': 'U/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat (ITT)'}, {'type': 'PRIMARY', 'title': 'GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '1036.19', 'spread': '2527.249', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 months', 'description': 'GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000', 'unitOfMeasure': 'U/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '347.01', 'spread': '1564.466', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 months', 'description': 'GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000', 'unitOfMeasure': 'U/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Number of Patients With an Infection Reported as Adverse Event Related to Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 1, 2, 3, 6, 9, 15 and 30', 'description': 'Number of patients with an infection reported as Adverse Event related to study treatment (GAD-Alum and/or Etanercept),as an assessment of the tolerability', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety'}, {'type': 'SECONDARY', 'title': 'C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.153', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months at 0, 30, 60, 90 and 120 minutes post-dose', 'description': 'Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 6 months. MMTT=Mixed Meal Tolerance Test', 'unitOfMeasure': 'nmol/L*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, MMTT not performed for 2 patients hence no data available for 2 out of the 20 patients'}, {'type': 'SECONDARY', 'title': 'C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.158', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months at 0, 30, 60, 90 and 120 minutes post-dose', 'description': 'Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 15 months', 'unitOfMeasure': 'nmol/L*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.168', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 months at 0, 30, 60, 90 and 120 minutes post-dose', 'description': 'Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 30 months', 'unitOfMeasure': 'nmol/L*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, , MMTT not performed for 1 patient hence no data available for 1 out of the 20 patients'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 months', 'description': 'Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 15 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 months', 'description': 'Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 30 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Hemoglobin A1c (HbA1c), Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '0.80', 'spread': '8.433', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Hemoglobin A1c (HbA1c), change from baseline to 6 months', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Hemoglobin A1c (HbA1c), Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '6.15', 'spread': '12.495', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'Hemoglobin A1c (HbA1c), change from baseline to 15 months', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Hemoglobin A1c (HbA1c), Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '7.55', 'spread': '11.213', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 months', 'description': 'Hemoglobin A1c (HbA1c), change from baseline to 30 months', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.249', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline', 'unitOfMeasure': 'IU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'spread': '0.342', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline', 'unitOfMeasure': 'IU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'spread': '0.333', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 months', 'description': 'Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline', 'unitOfMeasure': 'IU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'C-peptide: Stimulated, 90 Minute Value, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.233', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'C-peptide: Stimulated, 90 minute value, change from baseline to 6 months', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, not performed for 2 patients hence no data available for 2 out of the 20 patients'}, {'type': 'SECONDARY', 'title': 'C-peptide: Stimulated, 90 Minute Value, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.231', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'C-peptide: Stimulated, 90 minute value, change from baseline to 15 months', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'C-peptide: Stimulated, 90 Minute Value, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.221', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 months', 'description': 'C-peptide: Stimulated, 90 minute value, change from baseline to 30 months', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, not performed for 1 patient hence no data available for 1 out of the 20 patients'}, {'type': 'SECONDARY', 'title': 'C-peptide Fasting Concentration, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.083', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'C-peptide: Fasting concentration, change from baseline to 6 months', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'C-peptide Fasting Concentration, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.091', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months', 'description': 'C-peptide: Fasting, concentration, change from baseline to 15 months', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'C-peptide Fasting Concentration, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.093', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 months', 'description': 'C-peptide: Fasting, concentration, change from baseline to 30 months', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Spontaneous IL-17a Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'title': 'IL-17a, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.16', 'spread': '8.36', 'groupId': 'OG000'}]}]}, {'title': 'IL-17a, 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.07', 'spread': '10.13', 'groupId': 'OG000'}]}]}, {'title': 'IL-17a, 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.06', 'spread': '11.35', 'groupId': 'OG000'}]}]}, {'title': 'IL-17a,15 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.54', 'spread': '7.83', 'groupId': 'OG000'}]}]}, {'title': 'IL-17a, 30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.75', 'spread': '10.64', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months and 30 months', 'description': 'Spontaneous IL-17a secretion at baseline, 6 months, 9 months, 15 months and 30 months', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'GAD65-induced IL-4 Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'title': 'IL-4, baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '1.03', 'groupId': 'OG000'}]}]}, {'title': 'IL-4, 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'IL-4, 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'IL-4, 15 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '1.52', 'groupId': 'OG000'}]}]}, {'title': 'IL-4, 30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced IL-4 secretion at baseline, 6 months, 9 months, 15 months, 30 months', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'GAD65-induced IL-13 Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'title': 'IL-13, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '56.88', 'groupId': 'OG000'}]}]}, {'title': 'IL-13, 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '58.47', 'groupId': 'OG000'}]}]}, {'title': 'IL-13, 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.12', 'spread': '69.63', 'groupId': 'OG000'}]}]}, {'title': 'IL-13, 15 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '99.00', 'groupId': 'OG000'}]}]}, {'title': 'IL-13, 30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '49.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced IL-13 secretion at baseline, 6 months, 9 months, 15 months, 30 months', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'GAD65-induced IFN-gamma Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'title': 'IFN-gamma, baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.39', 'spread': '210.52', 'groupId': 'OG000'}]}]}, {'title': 'IFN-gamma, 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.44', 'spread': '223.16', 'groupId': 'OG000'}]}]}, {'title': 'IFN-gamma, 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.77', 'spread': '679.35', 'groupId': 'OG000'}]}]}, {'title': 'IFN-gamma, 15 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '1679.59', 'groupId': 'OG000'}]}]}, {'title': 'IFN-gamma, 30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '227.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced IFN-gamma secretion at baseline, 6 months, 9 months, 15 months, 30 months', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'GAD65-induced TNF-alpha Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'title': 'TNF-alpha, baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '348.28', 'groupId': 'OG000'}]}]}, {'title': 'TNF-alpha, 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '89.19', 'groupId': 'OG000'}]}]}, {'title': 'TNF-alpha, 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '355.09', 'groupId': 'OG000'}]}]}, {'title': 'TNF-alpha, 15 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '362.35', 'groupId': 'OG000'}]}]}, {'title': 'TNF-alpha, 30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '206.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced TNF-alpha secretion at baseline, 6 months, 9 months, 15 months, 30 months', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'GAD65-induced GM-CSF Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'title': 'GM-CSF, baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '16.96', 'groupId': 'OG000'}]}]}, {'title': 'GM-CSF, 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '18.00', 'groupId': 'OG000'}]}]}, {'title': 'GM-CSF, 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.52', 'spread': '24.70', 'groupId': 'OG000'}]}]}, {'title': 'GM-CSF, 15 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '36.95', 'groupId': 'OG000'}]}]}, {'title': 'GM-CSF, 30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '6.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced GM-CSF secretion baseline, 6 months, 9 months, 15 months, 30 months', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'GAD65-induced MIP-1b Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'title': 'MIP-1b, baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '85.46', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1b, 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '57.78', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1b, 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '134.30', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1b, 15 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.64', 'spread': '302.04', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1b, 30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.61', 'spread': '72.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced MIP-1b secretion at baseline, 6 months, 9 months, 15 months, 30 months', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'GAD65-induced MCP-1 Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'classes': [{'title': 'MCP-1, baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '106.61', 'groupId': 'OG000'}]}]}, {'title': 'MCP-1, 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.54', 'spread': '89.74', 'groupId': 'OG000'}]}]}, {'title': 'MCP-1, 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '144.03', 'groupId': 'OG000'}]}]}, {'title': 'MCP-1, 15 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.42', 'spread': '203.74', 'groupId': 'OG000'}]}]}, {'title': 'MCP-1, 30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.50', 'spread': '220.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced MCP-1 secretion at baseline, 6 months, 9 months, 15 months, 30 months', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GAD-Alum+Vitamin D+Etanercept', 'description': 'All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.\n\nGAD-Alum\n\nVitamin D\n\nEtanercept'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12.36', 'spread': '2.321', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type 1 Diabetes duration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '81.35', 'spread': '22.091', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18.38', 'spread': '2.141', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-03-17', 'size': 531372, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-08T08:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2015-05-19', 'resultsFirstSubmitDate': '2019-06-10', 'studyFirstSubmitQcDate': '2015-06-04', 'lastUpdatePostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-24', 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability', 'timeFrame': '1 months', 'description': 'Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse'}, {'measure': 'Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability', 'timeFrame': '2 months', 'description': 'Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse'}, {'measure': 'Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline', 'timeFrame': 'Month 1, 2, 3, 6, 9, 15 and 30', 'description': 'Number of patients with any abnormal findings from physical examinations after baseline, including neurological assessments as an assessment of tolerability.'}, {'measure': 'Number of Patients With Clinically Significant Laboratory Findings', 'timeFrame': 'Month 1, 2, 3, 6, 9, 15 and 30', 'description': 'Number of patients with clinically significant laboratory findings, laboratory measurements as an assessment of the tolerability'}, {'measure': 'GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)', 'timeFrame': '6 months', 'description': 'GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000'}, {'measure': 'GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)', 'timeFrame': '15 months', 'description': 'GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000'}, {'measure': 'GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)', 'timeFrame': '30 months', 'description': 'GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000'}, {'measure': 'Number of Patients With an Infection Reported as Adverse Event Related to Study Treatment', 'timeFrame': 'Month 1, 2, 3, 6, 9, 15 and 30', 'description': 'Number of patients with an infection reported as Adverse Event related to study treatment (GAD-Alum and/or Etanercept),as an assessment of the tolerability'}], 'secondaryOutcomes': [{'measure': 'C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline', 'timeFrame': 'Baseline and 6 months at 0, 30, 60, 90 and 120 minutes post-dose', 'description': 'Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 6 months. MMTT=Mixed Meal Tolerance Test'}, {'measure': 'C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline', 'timeFrame': 'Baseline and 15 months at 0, 30, 60, 90 and 120 minutes post-dose', 'description': 'Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 15 months'}, {'measure': 'C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline', 'timeFrame': 'Baseline and 30 months at 0, 30, 60, 90 and 120 minutes post-dose', 'description': 'Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 30 months'}, {'measure': 'Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L', 'timeFrame': '6 months', 'description': 'Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 6 months'}, {'measure': 'Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L', 'timeFrame': '15 months', 'description': 'Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 15 months'}, {'measure': 'Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L', 'timeFrame': '30 months', 'description': 'Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 30 months'}, {'measure': 'Hemoglobin A1c (HbA1c), Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Hemoglobin A1c (HbA1c), change from baseline to 6 months'}, {'measure': 'Hemoglobin A1c (HbA1c), Change From Baseline', 'timeFrame': 'Baseline and 15 months', 'description': 'Hemoglobin A1c (HbA1c), change from baseline to 15 months'}, {'measure': 'Hemoglobin A1c (HbA1c), Change From Baseline', 'timeFrame': 'Baseline and 30 months', 'description': 'Hemoglobin A1c (HbA1c), change from baseline to 30 months'}, {'measure': 'Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline'}, {'measure': 'Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline', 'timeFrame': 'Baseline and 15 months', 'description': 'Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline'}, {'measure': 'Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline', 'timeFrame': 'Baseline and 30 months', 'description': 'Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline'}, {'measure': 'C-peptide: Stimulated, 90 Minute Value, Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'C-peptide: Stimulated, 90 minute value, change from baseline to 6 months'}, {'measure': 'C-peptide: Stimulated, 90 Minute Value, Change From Baseline', 'timeFrame': 'Baseline and 15 months', 'description': 'C-peptide: Stimulated, 90 minute value, change from baseline to 15 months'}, {'measure': 'C-peptide: Stimulated, 90 Minute Value, Change From Baseline', 'timeFrame': 'Baseline and 30 months', 'description': 'C-peptide: Stimulated, 90 minute value, change from baseline to 30 months'}, {'measure': 'C-peptide Fasting Concentration, Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'C-peptide: Fasting concentration, change from baseline to 6 months'}, {'measure': 'C-peptide Fasting Concentration, Change From Baseline', 'timeFrame': 'Baseline and 15 months', 'description': 'C-peptide: Fasting, concentration, change from baseline to 15 months'}, {'measure': 'C-peptide Fasting Concentration, Change From Baseline', 'timeFrame': 'Baseline and 30 months', 'description': 'C-peptide: Fasting, concentration, change from baseline to 30 months'}, {'measure': 'Spontaneous IL-17a Secretion', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months and 30 months', 'description': 'Spontaneous IL-17a secretion at baseline, 6 months, 9 months, 15 months and 30 months'}, {'measure': 'GAD65-induced IL-4 Secretion', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced IL-4 secretion at baseline, 6 months, 9 months, 15 months, 30 months'}, {'measure': 'GAD65-induced IL-13 Secretion', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced IL-13 secretion at baseline, 6 months, 9 months, 15 months, 30 months'}, {'measure': 'GAD65-induced IFN-gamma Secretion', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced IFN-gamma secretion at baseline, 6 months, 9 months, 15 months, 30 months'}, {'measure': 'GAD65-induced TNF-alpha Secretion', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced TNF-alpha secretion at baseline, 6 months, 9 months, 15 months, 30 months'}, {'measure': 'GAD65-induced GM-CSF Secretion', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced GM-CSF secretion baseline, 6 months, 9 months, 15 months, 30 months'}, {'measure': 'GAD65-induced MIP-1b Secretion', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced MIP-1b secretion at baseline, 6 months, 9 months, 15 months, 30 months'}, {'measure': 'GAD65-induced MCP-1 Secretion', 'timeFrame': 'Baseline, 6 months, 9 months, 15 months, 30 months', 'description': 'GAD65-induced MCP-1 secretion at baseline, 6 months, 9 months, 15 months, 30 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diamyd', 'Diabetes', 'Juvenile Diabetes', 'Diabetes Type 1', 'Type 1 Diabetes', 'Autoimmune Diabetes', 'Insulin Dependent Diabetes', 'Type 1 Diabetes MellitusType 1 Diabetes Mellitus', 'rhGAD65', 'GAD65', 'GAD-Alum', 'Diabetes Mellitus', 'Diabetes mellitus Type 1', 'Glucose Metabolism Disorders', 'Metabolic Diseases', 'Vitamin D', 'Etanercept'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'The objectives of this study is to:\n\n* Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and etanercept\n* Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent given by patients and parent(s)/legal guardian(s)\n2. Type 1 diabetes according to the ADA classification, diagnosed within the previous 100 days at the time of screening\n3. Age 8.00 -17.99 years at time of screening\n4. Fasting C-peptide at time of screening ≥0.12 nmol/L\n5. Positive for GADA but \\< 50 000 Units\n6. Menarchal females must agree to avoid pregnancy and have a negative urine pregnancy test\n7. Immunity against Varicella, either through previous infection or vaccination\n8. Patients must follow the Swedish vaccination programme\n9. Patients of childbearing potential must agree to using adequate contraception, if sexually active, until 1 year after the last administration of GAD-alum and etanercept. Adequate contraception is as follows:\n\nFor females of childbearing potential:\n\n1. oral (except low-dose gestagen (lynestrenol and norethisterone), injectable, or implanted hormonal contraceptives (females)\n2. intrauterine device (females)\n3. intrauterine system (for example, progestin-releasing coil) (females)\n4. vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate)\n\nFor males of childbearing potential:\n\na. Condom (male)\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 (especially hypoglycemic agents) other than insulin\n4. Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the trial\n5. A history of hypercalcemia\n6. A history of anaemia or significantly abnormal haematology results at screening\n7. A history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles\n8. Clinically significant history of acute reaction to vaccines or other drugs in the past\n9. Treatment with any vaccine within 4 months prior to planned first administration of GAD-Alum or planned treatment with vaccine up to 4 months after the last injection with GAD-Alum, including influenza vaccine\n10. Participation in other clinical trials with a new chemical entity within the previous 3 months\n11. Inability or unwillingness to comply with the provisions of this protocol\n12. A history of alcohol or drug abuse\n13. A significant illness other than diabetes within 2 weeks prior to first dosing\n14. Known human immunodeficiency virus (HIV)\n15. Prior or active viral hepatitis B or C infection\n16. Females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior to the GAD-Alum and etanercept administration, respectively)\n17. Males or females not willing to use adequate contraception, if sexually active, until 1 year after the last GAD-Alum and etanercept administration, respectively\n18. Presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigator makes the patient non-eligible for the study.\n19. Deemed by the investigator not being able to follow instructions and/or follow the study protocol\n20. Active infection, including chronic and local infection or a history of previous tendency to serious infections, recent or ongoing uncontrolled bacterial, viral, fungal or other opportunistic infections, or known infection with active EBV or CMV\n21. Hypersensitivity to the active substance in Enbrel (etanercept) or other ingredients in Enbrel\n22. Active or inactive (latent) tuberculosis (TBC) at screening\n23. History of malignancy or significant cardiovascular disease\n24. Current or history of leukopenia, anemia and/or thrombocytopenia\n25. Liver disease (clinical or hepatic enzymes \\>3 times the upper limit of normal (ULN))\n26. Renal insufficiency (clinical or creatinine \\>3 times the upper limit of normal (ULN))\n27. MS, undefined neurologic condition or known SLE, or anti-nuclear or known doublestranded DNA antibody positivity\n28. Arrhythmia\n29. Pancreatitis\n30. Vitamin D serum levels \\>100 nmol/L at screening'}, 'identificationModule': {'nctId': 'NCT02464033', 'briefTitle': 'EDCR Study - Etanercept Diamyd Combination Regimen -Open Trial to Evaluate Safety in Children With Type 1 Diabetes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Open Label Trial to Evaluate the Tolerability of a Combination Therapy Consisting of GAD-alum (Diamyd®), Etanercept and Vitamin D in Children and Adolescents Newly Diagnosed With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'EDCR IIa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.', 'interventionNames': ['Drug: GAD-Alum', 'Drug: Vitamin D', 'Drug: Etanercept']}], 'interventions': [{'name': 'GAD-Alum', 'type': 'DRUG', 'otherNames': ['Diamyd'], 'description': 'Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)', 'armGroupLabels': ['A']}, {'name': 'Vitamin D', 'type': 'DRUG', 'otherNames': ['Cholecalciferol'], 'armGroupLabels': ['A']}, {'name': 'Etanercept', 'type': 'DRUG', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsingborg', 'country': 'Sweden', 'facility': 'Helsingborg Hospital', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linköping University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Skåne University Hospital, UMAS', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Örebro', 'country': 'Sweden', 'facility': 'Örebro University Hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Sachsska, Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Uddevalla', 'country': 'Sweden', 'facility': 'Uddevalla Hospital', 'geoPoint': {'lat': 58.34784, 'lon': 11.9424}}, {'city': 'Västerås', 'country': 'Sweden', 'facility': 'Västerås Hospital', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'overallOfficials': [{'name': 'Johnny Ludvigsson, MD,PhD,Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linkoeping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnny Ludvigsson', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Swedish Child Diabetes Foundation', 'class': 'OTHER'}, {'name': 'Ostergotland County Council, Sweden', 'class': 'OTHER'}, {'name': 'Diamyd Medical AB', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Professor', 'investigatorFullName': 'Johnny Ludvigsson', 'investigatorAffiliation': 'Linkoeping University'}}}}