Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT00564395
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2007-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Detemir: Role in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069057', 'term': 'Insulin Detemir'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rheptull@montefiore.org', 'phone': '718-920-7004', 'title': 'Dr. Rubina Heptulla', 'organization': "Children's Hospital at Montefiore"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '10 days for each intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Detemir Mixed With RAI Injection', 'description': 'Participants who received Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for 10 days.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin Detemir and RAI Injection Separately', 'description': 'Participants who received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for 10 days.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir Mixed With RAI Injection', 'description': 'Participants who received Insulin Detemir mixed with RAI injection, twice daily as subcutaneous injection in either the first or last 10 days of the study.'}, {'id': 'OG001', 'title': 'Insulin Detemir and RAI Injection Separately', 'description': 'Participants who received Insulin Detemir and RAI as separate subcutaneous injections, twice daily in either the first or last 10 days of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '457', 'spread': '70', 'groupId': 'OG000'}, {'value': '469', 'spread': '112', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-48 hours post-dose', 'description': 'Blood glucose concentration in terms of mean AUC (0-48 hours)was determined in subjects treated with either Insulin Detemir mixed with RAI or Insulin Detemir and RAI as separate subcutaneous injections.', 'unitOfMeasure': 'mmol*hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Detemir+RAI, Then Insulin Detemir and RAI Separately', 'description': 'Participants first received, Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for 10 days. Then they received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for the next 10 days.'}, {'id': 'FG001', 'title': 'Insulin Detemir and RAI Separately, Then Insulin Detemir+RAI', 'description': 'Participants first received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for 10 days. Then they received Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for the next 10 days'}], 'periods': [{'title': 'First Intervention (10 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Received Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Trouble with the CGM tracing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Second Intervention (10 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Eighteen participants were recruited for this trial. However, only 14 participants completed both study visits. Subjects were recruited from the clinics through fliers and online postings', 'preAssignmentDetails': 'One male subject dropped out because of a very active sports schedule and could not continue participation.\n\nThree subjects (two males and one female) had trouble with the Continuous Glucose Monitoring (CGM) tracing and, therefore, were excluded from the final analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Participants who were randomized to receive either Insulin Detemir mixed with RAI subcutaneous injection twice daily or Insulin Detemir and RAI as separate subcutaneous injections, twice daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '2.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-13', 'studyFirstSubmitDate': '2007-11-27', 'resultsFirstSubmitDate': '2018-03-02', 'studyFirstSubmitQcDate': '2007-11-27', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-13', 'studyFirstPostDateStruct': {'date': '2007-11-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections', 'timeFrame': '0-48 hours post-dose', 'description': 'Blood glucose concentration in terms of mean AUC (0-48 hours)was determined in subjects treated with either Insulin Detemir mixed with RAI or Insulin Detemir and RAI as separate subcutaneous injections.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['blood sugar', 'glycemic'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '20504899', 'type': 'BACKGROUND', 'citation': 'Nguyen TM, Renukuntla VS, Heptulla RA. Mixing insulin aspart with detemir does not affect glucose excursion in children with type 1 diabetes. Diabetes Care. 2010 Aug;33(8):1750-2. doi: 10.2337/dc10-0169. Epub 2010 May 26.'}]}, 'descriptionModule': {'briefSummary': 'Study of blood sugars in the children with Type 1 Diabetes Mellitus (T1DM), who are given insulin detemir and a rapid acting insulin (aspart). It is hypothesized that there is no difference in the patterns of blood sugars when detemir is given in the same syringe or in separate syringes with rapid acting insulin.', 'detailedDescription': 'One of the barriers to good glycemic control in children with type 1 diabetes is multiple daily insulin injections. Mixing rapid-acting (detemir) and slow- acting insulins (aspart) in the same syringe would decrease the number of injections and may improve adherence\n\nThis study hypothesized that slow-acting insulin detemir mixed with aspart would have equivalent effects on blood glucose versus giving them as separate injections in children with type 1 diabetes.\n\nEighteen pediatric subjects with type 1 diabetes (11 males and 7 females) were recruited. However only 14 subjects completed this 20-day, randomized, crossover, and open-labeled study. The subjects were randomly assigned to either Study A (both insulin detemir and rapid acting insulin (RAI)) or Study B (either detemir or aspart) for the first 10 days. They were then crossed over for the last 10 days. Each subject underwent 72 h of continuous glucose monitoring (CGM) during the last 72 h, for both Study A and Study B.Data of 48 h from midnight of the 1st day to mid- night of the 3rd day of the 72-h (CGM) were used for analysis to ensure the same starting and ending times of monitoring for all subjects.Sustained glucose values over time were calculated as area under the curve (AUC), index of blood glucose control as M-value and glucose excursion as mean amplitude of glucose excursion (MAGE)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with antibody positive Type 1 Diabetes Mellitus (T1DM)\n* On insulin glargine for at least 3 months\n* Age 10-25 years\n* Not on medications that may affect glucose concentrations\n* Hemoglobin A1C (HbA1C) of less than 9 %\n* Body Mass Index (BMI) less than 95th % and more than 10th%\n* Supportive family\n\nExclusion Criteria:\n\n* Subjects with undetermined diabetes or Type 2 Diabetes Mellitus (T2DM)\n* Unable to adhere to insulin regimen\n* Positive urine pregnancy test'}, 'identificationModule': {'nctId': 'NCT00564395', 'briefTitle': 'Detemir: Role in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Role of Insulin Aspart and Detemir to Assess Glucose Excursion in Children With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'H-16541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Detemir+RAI, then Insulin Detemir and RAI separately', 'description': 'Participants first received, Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for 10 days. Then they received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for the next 10 days.', 'interventionNames': ['Drug: Insulin Detemir mixed with RAI injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Detemir and RAI separately, then Insulin Detemir+RAI', 'description': 'Participants first received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for 10 days. Then they received Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for the next 10 days.', 'interventionNames': ['Drug: Insulin Detemir and RAI injection']}], 'interventions': [{'name': 'Insulin Detemir mixed with RAI injection', 'type': 'DRUG', 'description': 'Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection', 'armGroupLabels': ['Insulin Detemir+RAI, then Insulin Detemir and RAI separately']}, {'name': 'Insulin Detemir and RAI injection', 'type': 'DRUG', 'description': 'Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection', 'armGroupLabels': ['Insulin Detemir and RAI separately, then Insulin Detemir+RAI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital Endocrine and Diabetes Clinic", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Rubina A Heptulla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rubina Heptulla', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}