Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT00686712
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2008-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Insulin Glargine at Bedtime or in AM Versus NPH
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016568', 'term': 'Drugs, Generic'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stanleyhsia@cdrewu.edu', 'phone': '323-357-3633', 'title': 'Stanley H. Hsia, MD', 'organization': 'Charles R. Drew University of Medicine and Science'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination leading to smaller than anticipated enrollment.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Glargine at Bedtime', 'description': 'Bedtime insulin glargine titrated to morning fasting glucose readings', 'otherNumAtRisk': 30, 'otherNumAffected': 23, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin Glargine in AM', 'description': 'Morning insulin glargine titrated to pre-supper glucose readings', 'otherNumAtRisk': 25, 'otherNumAffected': 24, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'NPH Insulin', 'description': 'Bedtime NPH insulin titrated to morning fasting glucose readings', 'otherNumAtRisk': 30, 'otherNumAffected': 23, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Symptomatic Hypoglycemia', 'notes': 'Classic symptoms of hypoglycemia, relieved by carbohydrate ingestion, with or without a corroborating self-monitored glucose reading', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 200, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 239, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 247, 'numAffected': 23}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asymptomatic Retinal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Foot Infection (Hospitalization)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemoglobin A1c Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine at Bedtime', 'description': 'Bedtime insulin glargine titrated to morning fasting glucose readings'}, {'id': 'OG001', 'title': 'Insulin Glargine in AM', 'description': 'Morning insulin glargine titrated to pre-supper glucose readings'}, {'id': 'OG002', 'title': 'NPH Insulin', 'description': 'Bedtime NPH insulin titrated to morning fasting glucose readings'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (LOCF)', 'anticipatedPostingDate': '2010-09'}, {'type': 'SECONDARY', 'title': 'Frequency of Glucose Readings < 130 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 - Insulin Glargine QHS', 'description': 'Insulin glargine injected subcutaneously once daily at bedtime\n\nInsulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \\<120 mg/dL)'}, {'id': 'OG001', 'title': '2 - Insulin Glargine QAM', 'description': 'Insulin glargine injected subcutaneously once daily in the morning\n\nInsulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \\<120 mg/dL)'}, {'id': 'OG002', 'title': '3 - NPH Insulin QHS', 'description': 'NPH insulin injected subcutaneously once daily at bedtime\n\nNPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \\<120 mg/dL)'}], 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '73.0', 'spread': '25.1', 'groupId': 'OG001'}, {'value': '72.6', 'spread': '22.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL', 'unitOfMeasure': 'percentage of readings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled subjects'}, {'type': 'SECONDARY', 'title': 'Frequency of Total Hypoglycemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 - Insulin Glargine QHS', 'description': 'Insulin glargine injected subcutaneously once daily at bedtime\n\nInsulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \\<120 mg/dL)'}, {'id': 'OG001', 'title': '2 - Insulin Glargine QAM', 'description': 'Insulin glargine injected subcutaneously once daily in the morning\n\nInsulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \\<120 mg/dL)'}, {'id': 'OG002', 'title': '3 - NPH Insulin QHS', 'description': 'NPH insulin injected subcutaneously once daily at bedtime\n\nNPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \\<120 mg/dL)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '8.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Frequency of hypoglycemic reactions without regard to time of occurrence', 'unitOfMeasure': 'Hypoglycemic events per patient', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled subjects'}, {'type': 'SECONDARY', 'title': 'Frequency of Severe Hypoglycemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 - Insulin Glargine QHS', 'description': 'Insulin glargine injected subcutaneously once daily at bedtime\n\nInsulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \\<120 mg/dL)'}, {'id': 'OG001', 'title': '2 - Insulin Glargine QAM', 'description': 'Insulin glargine injected subcutaneously once daily in the morning\n\nInsulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \\<120 mg/dL)'}, {'id': 'OG002', 'title': '3 - NPH Insulin QHS', 'description': 'NPH insulin injected subcutaneously once daily at bedtime\n\nNPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \\<120 mg/dL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person', 'unitOfMeasure': 'Severe hypoglycemic events', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled subjects'}, {'type': 'SECONDARY', 'title': 'Body Mass Index Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 - Insulin Glargine QHS', 'description': 'Insulin glargine injected subcutaneously once daily at bedtime\n\nInsulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \\<120 mg/dL)'}, {'id': 'OG001', 'title': '2 - Insulin Glargine QAM', 'description': 'Insulin glargine injected subcutaneously once daily in the morning\n\nInsulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \\<120 mg/dL)'}, {'id': 'OG002', 'title': '3 - NPH Insulin QHS', 'description': 'NPH insulin injected subcutaneously once daily at bedtime\n\nNPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \\<120 mg/dL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '1.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in body mass index from baseline BMI measurement', 'unitOfMeasure': 'kg per square meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled subjects'}, {'type': 'SECONDARY', 'title': 'Total Daily Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 - Insulin Glargine QHS', 'description': 'Insulin glargine injected subcutaneously once daily at bedtime\n\nInsulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \\<120 mg/dL)'}, {'id': 'OG001', 'title': '2 - Insulin Glargine QAM', 'description': 'Insulin glargine injected subcutaneously once daily in the morning\n\nInsulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \\<120 mg/dL)'}, {'id': 'OG002', 'title': '3 - NPH Insulin QHS', 'description': 'NPH insulin injected subcutaneously once daily at bedtime\n\nNPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \\<120 mg/dL)'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '14.6', 'spread': '13.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Total daily number of units of insulin used', 'unitOfMeasure': 'Units of insulin per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled subjects'}, {'type': 'SECONDARY', 'title': 'Any Adverse Event Other Than Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 - Insulin Glargine QHS', 'description': 'Insulin glargine injected subcutaneously once daily at bedtime\n\nInsulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \\<120 mg/dL)'}, {'id': 'OG001', 'title': '2 - Insulin Glargine QAM', 'description': 'Insulin glargine injected subcutaneously once daily in the morning\n\nInsulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \\<120 mg/dL)'}, {'id': 'OG002', 'title': '3 - NPH Insulin QHS', 'description': 'NPH insulin injected subcutaneously once daily at bedtime\n\nNPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \\<120 mg/dL)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Any reported adverse event that is not hypoglycemia', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Glargine at Bedtime', 'description': 'Bedtime insulin glargine titrated to morning fasting glucose readings'}, {'id': 'FG001', 'title': 'Insulin Glargine in AM', 'description': 'Morning insulin glargine titrated to pre-supper glucose readings'}, {'id': 'FG002', 'title': 'NPH Insulin', 'description': 'Bedtime NPH insulin titrated to morning fasting glucose readings'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment occurred from Sep 2002 to Feb 2009. Subjects recruited from a diabetes specialty referral clinic, as well as from primary care clinics and through advertising in the South Los Angeles area.', 'preAssignmentDetails': 'Baseline run-in period to document baseline control and reinforce dietary/lifestyle principles.\n\n23 subjects not randomized due to protocol violations, loss to follow-up, lack of need for insulin, or voluntarily.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Glargine at Bedtime', 'description': 'Bedtime insulin glargine titrated to morning fasting glucose readings'}, {'id': 'BG001', 'title': 'Insulin Glargine in AM', 'description': 'Morning insulin glargine titrated to pre-supper glucose readings'}, {'id': 'BG002', 'title': 'NPH Insulin', 'description': 'Bedtime NPH insulin titrated to morning fasting glucose readings'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '53.0', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '53.2', 'spread': '7.7', 'groupId': 'BG002'}, {'value': '52.1', 'spread': '9.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '9.6', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '9.3', 'spread': '1.6', 'groupId': 'BG002'}, {'value': '9.3', 'spread': '1.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes Duration', 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '9.5', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '7.8', 'spread': '4.2', 'groupId': 'BG002'}, {'value': '8.7', 'spread': '5.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '31.1', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '32.1', 'spread': '6.0', 'groupId': 'BG002'}, {'value': '31.6', 'spread': '5.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-18', 'studyFirstSubmitDate': '2008-05-27', 'resultsFirstSubmitDate': '2010-09-15', 'studyFirstSubmitQcDate': '2008-05-29', 'lastUpdatePostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-09-15', 'studyFirstPostDateStruct': {'date': '2008-05-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c Change From Baseline', 'timeFrame': 'Baseline to 6 months'}], 'secondaryOutcomes': [{'measure': 'Frequency of Glucose Readings < 130 mg/dL', 'timeFrame': '6 months', 'description': 'Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL'}, {'measure': 'Frequency of Total Hypoglycemic Reactions', 'timeFrame': '6 months', 'description': 'Frequency of hypoglycemic reactions without regard to time of occurrence'}, {'measure': 'Frequency of Severe Hypoglycemic Reactions', 'timeFrame': '6 months', 'description': 'Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person'}, {'measure': 'Body Mass Index Change From Baseline', 'timeFrame': '6 months', 'description': 'Change in body mass index from baseline BMI measurement'}, {'measure': 'Total Daily Insulin Dose', 'timeFrame': '6 months', 'description': 'Total daily number of units of insulin used'}, {'measure': 'Any Adverse Event Other Than Hypoglycemia', 'timeFrame': '6 months', 'description': 'Any reported adverse event that is not hypoglycemia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glargine', 'Type 2 diabetes', 'Basal insulin'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '33166419', 'type': 'DERIVED', 'citation': 'Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.'}, {'pmid': '21146881', 'type': 'DERIVED', 'citation': 'Hsia SH. Insulin glargine compared to NPH among insulin-naive, U.S. inner city, ethnic minority type 2 diabetic patients. Diabetes Res Clin Pract. 2011 Mar;91(3):293-9. doi: 10.1016/j.diabres.2010.11.028. Epub 2010 Dec 13.'}]}, 'descriptionModule': {'briefSummary': 'To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.', 'detailedDescription': 'Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when used as a once-nightly or morning basal insulin injection in type 2 diabetic patients who are inadequately controlled on combination oral agents has been controversial. Inner city ethnic minority patients with diabetes are a particularly challenging population of diabetic patients to treat. This study investigates whether insulin glargine may be a more effective or safer first-line basal insulin than NPH in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age 18-75\n* Type 2 diabetes diagnosed for at least 1 year\n* Treatment with stable doses of oral agents (alone or in combination) for at least 2 months\n* Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione\n* No past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)\n* Hemoglobin A1c between 7.5% and 12%\n* Body mass index (BMI) between 20 and 40 kg/m2\n\nExclusion Criteria:\n\n* Current or previous chronic use of insulin (other than for treatment of gestational diabetes)\n* History of confirmed (or clinical suspicion of) type 1 diabetes\n* Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception\n* Current pregnancy or lactation.\n* Subjects for whom insulin therapy is contraindicated or for whom, in the opinion of the investigator, therapy with insulin is not indicated\n* Subjects with advanced proliferative diabetic retinopathy\n* Subjects who work night shifts or who are unable to stay on a consistent daily meal schedule\n* History of any clinically significant renal, hepatic, cardiovascular, neurological, endocrinological or other major systemic disease that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the data difficult.\n* Subjects who will likely require or initiate therapy with drugs which may interfere with glucose metabolism during the course of the study\n* Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry\n* Subjects who are unable or unwilling to comply with all components of the study protocol, including contacting the investigators at specified times and attending all scheduled follow-up visits.'}, 'identificationModule': {'nctId': 'NCT00686712', 'briefTitle': 'Insulin Glargine at Bedtime or in AM Versus NPH', 'organization': {'class': 'OTHER', 'fullName': 'Charles Drew University of Medicine and Science'}, 'officialTitle': 'The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects Starting Insulin Therapy', 'orgStudyIdInfo': {'id': '03-02-524'}, 'secondaryIdInfos': [{'id': 'U54RR014616', 'link': 'https://reporter.nih.gov/quickSearch/U54RR014616', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 - Insulin glargine QHS', 'description': 'Insulin glargine injected subcutaneously once daily at bedtime', 'interventionNames': ['Drug: 1- Insulin glargine QHS']}, {'type': 'EXPERIMENTAL', 'label': '2 - Insulin glargine QAM', 'description': 'Insulin glargine injected subcutaneously once daily in the morning', 'interventionNames': ['Drug: 2 - Insulin glargine QAM']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 - NPH Insulin QHS', 'description': 'NPH insulin injected subcutaneously once daily at bedtime', 'interventionNames': ['Drug: 3 - NPH insulin QHS']}], 'interventions': [{'name': '1- Insulin glargine QHS', 'type': 'DRUG', 'otherNames': ['Trade name: Lantus'], 'description': 'Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \\<120 mg/dL)', 'armGroupLabels': ['1 - Insulin glargine QHS']}, {'name': '2 - Insulin glargine QAM', 'type': 'DRUG', 'otherNames': ['Trade name: Lantus'], 'description': 'Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \\<120 mg/dL)', 'armGroupLabels': ['2 - Insulin glargine QAM']}, {'name': '3 - NPH insulin QHS', 'type': 'DRUG', 'otherNames': ['(Generic)'], 'description': 'NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \\<120 mg/dL)', 'armGroupLabels': ['3 - NPH Insulin QHS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90059', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Charles Drew University of Medicine and Science', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Stanley Hsia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles Drew University of Medicine and Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles Drew University of Medicine and Science', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}