Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-06 @ 8:12 PM
Study NCT ID:
NCT00623194
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2008-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069057', 'term': 'Insulin Detemir'}, {'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'Novo Nordisk reserves the right not to release data until specified milestones, e.g., a Clinical Trial Report is available. At the end of the trial, one or more manuscripts for publication will be prepared in collaboration between authors and Novo Nordisk. Novo Nordisk will not suppress or veto publications; however Novo Nordisk reserves the right to postpone publication and/or communication for a short time to protect intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected over a period of 104 weeks.', 'description': 'The safety analysis set is all subjects exposed to at least one dose of trial drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)', 'otherNumAtRisk': 146, 'otherNumAffected': 108, 'seriousNumAtRisk': 146, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 164, 'numAffected': 71}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 44, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 41, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 38, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 16, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Acute Tonsilliitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 84, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Gastroenteritis shigella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Hypoglycaemia unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}, {'term': 'Burns second degrees', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Detemir-insulin Aspart Cross-reacting Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'title': 'Week 0 (3 hours)', 'categories': [{'measurements': [{'value': '31.11', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (3 hours)', 'categories': [{'measurements': [{'value': '43.99', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 104 (3 hours)', 'categories': [{'measurements': [{'value': '35.96', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 0 (2.5 hours)', 'categories': [{'measurements': [{'value': '31.22', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (2.5 hours)', 'categories': [{'measurements': [{'value': '44.09', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 104 (2.5 hours)', 'categories': [{'measurements': [{'value': '35.92', 'spread': '1.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, 52 and 104', 'description': 'Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection.', 'unitOfMeasure': 'Percent bound of total', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set 146 (100%), safety analysis set 146 (100%)\n\nThe full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.\n\nThe safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'title': 'Insulin Detemir specific, week 0', 'categories': [{'measurements': [{'value': '2.81', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Insulin Detemir specific, week 52', 'categories': [{'measurements': [{'value': '4.40', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'Insulin Detemir specific, week 104', 'categories': [{'measurements': [{'value': '3.05', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'Insulin Aspart specific, week 0', 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Insulin Aspart specific, week 52', 'categories': [{'measurements': [{'value': '2.79', 'spread': '0.64', 'groupId': 'OG000'}]}]}, {'title': 'Insulin Aspart specific, week 104', 'categories': [{'measurements': [{'value': '1.99', 'spread': '0.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 0, 52 and 104 weeks', 'description': 'Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks.', 'unitOfMeasure': 'Percent bound of total', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension period.'}, {'type': 'SECONDARY', 'title': 'Glycosylated Haemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.74', 'spread': '1.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 104 weeks', 'description': 'Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.', 'unitOfMeasure': 'Percent (%) glycosylated haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.'}, {'type': 'SECONDARY', 'title': 'Fasting Plasma Glucose Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.71', 'spread': '3.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 104 weeks', 'description': 'FPG (Fasting Plasma Glucose) values after 104 weeks.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.'}, {'type': 'SECONDARY', 'title': 'Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'title': 'Overall, Mild', 'categories': [{'measurements': [{'value': '10530', 'groupId': 'OG000'}]}]}, {'title': 'Overall, Moderate', 'categories': [{'measurements': [{'value': '450', 'groupId': 'OG000'}]}]}, {'title': 'Overall, Severe', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Overall, Biochemical', 'categories': [{'measurements': [{'value': '5080', 'groupId': 'OG000'}]}]}, {'title': 'Overall, Unclassified', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Daytime, Mild', 'categories': [{'measurements': [{'value': '9080', 'groupId': 'OG000'}]}]}, {'title': 'Daytime, Moderate', 'categories': [{'measurements': [{'value': '396', 'groupId': 'OG000'}]}]}, {'title': 'Daytime, Severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Daytime, Biochemical', 'categories': [{'measurements': [{'value': '4122', 'groupId': 'OG000'}]}]}, {'title': 'Daytime, Unclassified', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Night-time, Mild', 'categories': [{'measurements': [{'value': '1450', 'groupId': 'OG000'}]}]}, {'title': 'Night-time, Moderate', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Night-time, Severe', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Night-time, Biochemical', 'categories': [{'measurements': [{'value': '958', 'groupId': 'OG000'}]}]}, {'title': 'Night-time, Unclassified', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Total hypoglycaemic episodes', 'categories': [{'measurements': [{'value': '16074', 'groupId': 'OG000'}]}]}, {'title': 'Total hypoglycaemic episodes, daytime', 'categories': [{'measurements': [{'value': '13605', 'groupId': 'OG000'}]}]}, {'title': 'Total hypoglycaemic episodes, night-time', 'categories': [{'measurements': [{'value': '2469', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-104', 'description': 'Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment.\n\nSevere: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'BMI (Body Mass Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '18.88', 'spread': '3.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 104 weeks', 'description': 'BMI (Body Mass Index) after 104 weeks.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'SD-score (Z-score) for Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '0.97', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 104 weeks', 'description': 'Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2.', 'unitOfMeasure': 'SD-scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'Diabetic Ketoacidosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 104 weeks', 'description': 'Diabetic ketoacidosis requiring hospitalisation', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'title': 'Insulin Detemir dose (Basal)', 'categories': [{'measurements': [{'value': '0.66', 'spread': '0.29', 'groupId': 'OG000'}]}]}, {'title': 'Insulin Aspart dose (Bolus)', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 104 weeks', 'description': 'Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.', 'unitOfMeasure': 'U/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'title': 'Albumin serum (n=144)', 'categories': [{'measurements': [{'value': '4.32', 'spread': '0.25', 'groupId': 'OG000'}]}]}, {'title': 'Total Protein serum (n=144)', 'categories': [{'measurements': [{'value': '7.09', 'spread': '0.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 104 weeks', 'description': 'Albumin Serum and Total Protein Serum after 104 weeks.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'Laboratory Values: Creatine Serum Umol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '51.08', 'spread': '13.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 104 weeks', 'description': 'Creatine serum after 104 weeks.', 'unitOfMeasure': 'Umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'title': 'Sodium Serum (n=144)', 'categories': [{'measurements': [{'value': '141.6', 'spread': '3.11', 'groupId': 'OG000'}]}]}, {'title': 'Potassium serum (n=137)', 'categories': [{'measurements': [{'value': '4.38', 'spread': '0.50', 'groupId': 'OG000'}]}]}, {'title': 'Haemoglobin (n=144)', 'categories': [{'measurements': [{'value': '8.28', 'spread': '0.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 104 weeks', 'description': 'Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'title': 'Alkaline phosphatase serum (n=144)', 'categories': [{'measurements': [{'value': '226.7', 'spread': '197.10', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase serum (n=144)', 'categories': [{'measurements': [{'value': '19.0', 'spread': '8.26', 'groupId': 'OG000'}]}]}, {'title': 'Lactate Dehydrogenase serum (n=137)', 'categories': [{'measurements': [{'value': '199.6', 'spread': '40.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 104 weeks', 'description': 'Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'Laboratory Values: Leukocytes and Thrombocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'title': 'Leukocytes (n=144)', 'categories': [{'measurements': [{'value': '6.72', 'spread': '1.85', 'groupId': 'OG000'}]}]}, {'title': 'Thrombocytes (n=144)', 'categories': [{'measurements': [{'value': '301.90', 'spread': '76.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 104 weeks', 'description': 'Leukocytes and Thrombocytes after 104 weeks.', 'unitOfMeasure': '10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'Fundoscopy/Fundus Photography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'title': 'Abnormal, clinically significant', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Abnormal, not clinically significant', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Normal', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Abn CS baseline and 104 weeks', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 52 weeks and at 104 weeks', 'description': 'Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant\n\nAbn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'Vital Signs: Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '109.5', 'spread': '13.6', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '66.6', 'spread': '8.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 104 weeks', 'description': 'Blood pressure (Systolic and Diastolic) after 104 weeks.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}, {'type': 'SECONDARY', 'title': 'Vital Signs: Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '82.6', 'spread': '9.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 104 weeks', 'description': 'Pulse at week 104', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '29 sites in 11 countries: (Bulgaria (3 sites), Czech Republic (3 sites), Denmark (2 sites), Finland (4 sites), France (1 site), Hungary (2 sites), Macedonia (1 site), Poland (4 sites), Russian Federation (4 sites), Turkey (4 sites) and United Kingdom (1 site)', 'preAssignmentDetails': 'At entry subjects had finalised 52-weeks treatment with insulin detemir plus insulin aspart (Trial NN304-1689, NCT00435019). Subjects treated with NPH insulin plus insulin aspart in trial NN304-1689 were not offered to continue in this extension trial. Subjects continued treatment with insulin detemir and insulin aspart doses from trial NN304-1689.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '4.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age at entry in NN304-1689 (NCT00435019)', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '144', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age', 'classes': [{'title': '2-5 years', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': '6-12 years', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}, {'title': '13-16 years', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of subjects in each age group at entry in NN304-1689 (NCT00435019)', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.39', 'spread': '0.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Height at entry in NN304-1689 (NCT00435019)', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '18.14', 'spread': '2.81', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index (BMI) at entry in NN304-1689 (NCT00435019)', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pubertal Status', 'classes': [{'title': 'Tanner grade 1', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}, {'title': 'Tanner grade 2+', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Tanner scale:\n\nPre-pubertal: Tanner grade 1: the vellus over the pubes is not further developed than that over the abdominal wall, i.e. no pubic hair.\n\nPubertal: Tanner grade 2 or more: sparse growth of long slightly pigmented downy hair, straight, or slightly curled, chiefly at base of penis or along labia.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2008-02-14', 'resultsFirstSubmitDate': '2010-09-05', 'studyFirstSubmitQcDate': '2008-02-14', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-23', 'studyFirstPostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Detemir-insulin Aspart Cross-reacting Antibodies', 'timeFrame': 'week 0, 52 and 104', 'description': 'Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection.'}], 'secondaryOutcomes': [{'measure': 'Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies', 'timeFrame': 'At 0, 52 and 104 weeks', 'description': 'Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks.'}, {'measure': 'Glycosylated Haemoglobin A1c (HbA1c)', 'timeFrame': 'At 104 weeks', 'description': 'Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.'}, {'measure': 'Fasting Plasma Glucose Values', 'timeFrame': 'At 104 weeks', 'description': 'FPG (Fasting Plasma Glucose) values after 104 weeks.'}, {'measure': 'Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-104', 'description': 'Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment.\n\nSevere: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment.'}, {'measure': 'BMI (Body Mass Index)', 'timeFrame': 'At 104 weeks', 'description': 'BMI (Body Mass Index) after 104 weeks.'}, {'measure': 'SD-score (Z-score) for Body Weight', 'timeFrame': 'At 104 weeks', 'description': 'Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2.'}, {'measure': 'Diabetic Ketoacidosis', 'timeFrame': 'At 104 weeks', 'description': 'Diabetic ketoacidosis requiring hospitalisation'}, {'measure': 'Insulin Dose', 'timeFrame': 'At 104 weeks', 'description': 'Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.'}, {'measure': 'Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)', 'timeFrame': 'At 104 weeks', 'description': 'Albumin Serum and Total Protein Serum after 104 weeks.'}, {'measure': 'Laboratory Values: Creatine Serum Umol/L', 'timeFrame': 'At 104 weeks', 'description': 'Creatine serum after 104 weeks.'}, {'measure': 'Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)', 'timeFrame': 'At 104 weeks', 'description': 'Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.'}, {'measure': 'Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)', 'timeFrame': 'At 104 weeks', 'description': 'Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.'}, {'measure': 'Laboratory Values: Leukocytes and Thrombocytes', 'timeFrame': 'At 104 weeks', 'description': 'Leukocytes and Thrombocytes after 104 weeks.'}, {'measure': 'Fundoscopy/Fundus Photography', 'timeFrame': 'at 52 weeks and at 104 weeks', 'description': 'Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant\n\nAbn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant'}, {'measure': 'Vital Signs: Blood Pressure', 'timeFrame': 'At 104 weeks', 'description': 'Blood pressure (Systolic and Diastolic) after 104 weeks.'}, {'measure': 'Vital Signs: Pulse', 'timeFrame': 'At 104 weeks', 'description': 'Pulse at week 104'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '27600385', 'type': 'BACKGROUND', 'citation': 'Thalange N, Bereket A, Jensen LB, Hiort LC, Peterkova V. Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years. Diabetes Ther. 2016 Dec;7(4):713-724. doi: 10.1007/s13300-016-0196-5. Epub 2016 Sep 6.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the subject must sign and date the Informed Consent Form.\n* Finalised 52 weeks of treatment with insulin detemir in trial NN304-1689.\n* Fertile females (girls who have had their first menstrual period) must use adequate contraception (barrier methods, contraceptive pills or intrauterine device (IUD)) if there is any risk of pregnancy in the opinion of the Investigator. For Denmark and France only contraceptive pills or intrauterine device are considered as adequate contraceptive methods.\n\nExclusion Criteria:\n\n* Significant concomitant disease such as endocrine, hepatic, renal, cardiac, respiratory, neurological, gastrointestinal, malignant or pancreatic diseases as judged by the Investigator.\n* Pregnant or the intention of becoming pregnant.\n* Previous participation in this trial (defined as enrolment).'}, 'identificationModule': {'nctId': 'NCT00623194', 'briefTitle': 'Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin', 'orgStudyIdInfo': {'id': 'NN304-1690'}, 'secondaryIdInfos': [{'id': '2006-002478-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'insulin detemir', 'description': 'Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)', 'interventionNames': ['Drug: insulin detemir', 'Drug: insulin aspart']}], 'interventions': [{'name': 'insulin detemir', 'type': 'DRUG', 'description': 'Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.', 'armGroupLabels': ['insulin detemir']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Treat-to target dose titration scheme (individually adjusted), injection s.c. 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'NR4 7UY', 'city': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site'}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}