Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT00338104
Status:
COMPLETED
Last Update Posted:
2009-04-06
First Post:
2006-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}], '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': 'molitch@northwestern.edu', 'phone': '312 503-4130', 'title': 'Mark E. Molitch, M.D.', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'not all patients were analyzed in each group because insulin not given appropriately to those patients'}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Blood Glucose Values Between 80 - 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '40% Group', 'description': 'Glargine at 40% of insulin drip rate'}, {'id': 'OG001', 'title': '60% Group', 'description': 'Glargine at 60% of insulin drip rate'}, {'id': 'OG002', 'title': '80% Group', 'description': 'Glargine at 80% of insulin drip rate'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 24 hours after conversion', 'description': 'Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL', 'unitOfMeasure': 'percentage of blood glucose values', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Glucose Values < 50 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '40% Group', 'description': 'Glargine at 40% of insulin drip rate'}, {'id': 'OG001', 'title': '60% Group', 'description': 'Glargine at 60% of insulin drip rate'}, {'id': 'OG002', 'title': '80% Group', 'description': 'Glargine at 80% of insulin drip rate'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 24 hours after conversion', 'description': 'Percentage of blood glucose values \\< 50 mg/dL', 'unitOfMeasure': 'percentage of blood glucose values', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Glucose Levels > 180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '40% Group', 'description': 'Glargine at 40% of insulin drip rate'}, {'id': 'OG001', 'title': '60% Group', 'description': 'Glargine at 60% of insulin drip rate'}, {'id': 'OG002', 'title': '80% Group', 'description': 'Glargine at 80% of insulin drip rate'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 24 hours after conversion', 'description': 'Percentage of blood glucose levels \\> 180 mg/dL', 'unitOfMeasure': 'percentage of blood glucose values', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '40% Group', 'description': 'Glargine at 40% of insulin drip rate'}, {'id': 'FG001', 'title': '60% Group', 'description': 'Glargine at 60% of insulin drip rate'}, {'id': 'FG002', 'title': '80% Group', 'description': 'Glargine at 80% of insulin drip rate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '75 patients with hyperglycemia were recruited from the inpatient service at Northwestern Memorial Hospital between August, 2004 and May, 2005.', 'preAssignmentDetails': 'Patients had to be on a continuous insulin infusion to treat hyperglycemia prior to randomization'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '40% Group', 'description': 'Glargine at 40% of insulin drip rate'}, {'id': 'BG001', 'title': '60% Group', 'description': 'Glargine at 60% of insulin drip rate'}, {'id': 'BG002', 'title': '80% Group', 'description': 'Glargine at 80% of insulin drip rate'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '60.7', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '58.6', 'spread': '10.2', 'groupId': 'BG002'}, {'value': '60.2', 'spread': '11.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '30.6', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '29.9', 'spread': '8.0', 'groupId': 'BG002'}, {'value': '29.8', 'spread': '6.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-03', 'studyFirstSubmitDate': '2006-06-15', 'resultsFirstSubmitDate': '2008-12-01', 'studyFirstSubmitQcDate': '2006-06-15', 'lastUpdatePostDateStruct': {'date': '2009-04-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-03', 'studyFirstPostDateStruct': {'date': '2006-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Blood Glucose Values Between 80 - 140', 'timeFrame': 'First 24 hours after conversion', 'description': 'Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL'}], 'secondaryOutcomes': [{'measure': 'Percentage of Glucose Values < 50 mg/dL', 'timeFrame': 'First 24 hours after conversion', 'description': 'Percentage of blood glucose values \\< 50 mg/dL'}, {'measure': 'Percentage of Glucose Levels > 180 mg/dL', 'timeFrame': 'First 24 hours after conversion', 'description': 'Percentage of blood glucose levels \\> 180 mg/dL'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin', 'glargine', 'intravenous', 'subcutaneous', 'hospital', 'diabetes', 'glucose', 'inpatient'], 'conditions': ['Hyperglycemia', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '17229660', 'type': 'RESULT', 'citation': "Schmeltz LR, DeSantis AJ, Schmidt K, O'Shea-Mahler E, Rhee C, Brandt S, Peterson S, Molitch ME. Conversion of intravenous insulin infusions to subcutaneously administered insulin glargine in patients with hyperglycemia. Endocr Pract. 2006 Nov-Dec;12(6):641-50. doi: 10.4158/EP.12.6.641."}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the optimal dose of glargine insulin when converting from intravenous short-acting continuous insulin infusions in surgical and intensive care unit patients using a prospective, controlled, parallel group, randomized study design.\n\nNote: Lantus insulin is the proprietary name for glargine insulin.', 'detailedDescription': 'Critical illness causes an impairment of insulin secretion and insulin action, resulting in hyperglycemia even in normal individuals and a worsening of the hyperglycemia in patients with diabetes. Normalization of elevated glucose levels by intensive insulin infusion therapy in these critically ill patients has been proven to dramatically improve in-hospital mortality rates. After glucose levels have been controlled with insulin infusions, the best way to convert them to subcutaneous insulin regimens has not been demonstrated conclusively but the insulin regimen best suited is a combination of a basal insulin such as glargine (Lantus) insulin with premeal insulin boluses using a short-acting insulin such as Lispro or Aspart.\n\nSubjects will be randomized into three groups, 25 subjects in each group, the groups differing according to the starting dose of glargine insulin as follows:\n\n1. Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.4 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion;\n2. Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.6 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion;\n3. Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.8 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion.\n\nThe glargine insulin will then be continued as the basal insulin, adjusting doses every 24 hours based on the fasting blood glucose level. In addition, patients will receive Lispro or Aspart insulin as prandial bolus insulins with the goals premeal being 80 - 120 mg/dl, including bedtime. Glucose measurements will be obtained every 1- 4 hours while patients are on their insulin infusions, depending upon the stability of their condition and the stability of their glucose levels. Following transfer to glargine insulin, they will have glucose measured at least four times per day, premeal and bedtime as per standard protocol in the hospital for patients receiving insulin. Glucose data will be obtained from such patients and this will be compared among the various glargine regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting glucose \\> 100 mg/dl\n* Patients on surgical services or in intensive care units receiving intravenous insulin\n\nExclusion Criteria:\n\n* Inability to obtain informed consent from patient or next-of-kin\n* Allergy to insulin\n* Participation in another research study\n* Patients for whom there are "do-not-resuscitate" orders'}, 'identificationModule': {'nctId': 'NCT00338104', 'briefTitle': 'Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin', 'orgStudyIdInfo': {'id': '0361-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '40% Glargine', 'description': 'Patients will receive a dose of glargine insulin equal to 40% of insulin drip rate.', 'interventionNames': ['Drug: insulin glargine']}, {'type': 'EXPERIMENTAL', 'label': '60% Glargine', 'description': 'Patients will receive a dose of glargine insulin equal to 60% of insulin drip rate.', 'interventionNames': ['Drug: insulin glargine']}, {'type': 'EXPERIMENTAL', 'label': '80% Glargine', 'description': 'Patients will receive a dose of glargine insulin equal to 80% of insulin drip rate.', 'interventionNames': ['Drug: insulin glargine']}], 'interventions': [{'name': 'insulin glargine', 'type': 'DRUG', 'otherNames': ['Lantus is brand name for Glargine'], 'description': 'Insulin glargine given at 40% of prior stable drip rate.', 'armGroupLabels': ['40% Glargine']}, {'name': 'insulin glargine', 'type': 'DRUG', 'otherNames': ['Lantus is brand name for Glargine'], 'description': 'Insulin glargine given at 60% of prior stable drip rate.', 'armGroupLabels': ['60% Glargine']}, {'name': 'insulin glargine', 'type': 'DRUG', 'otherNames': ['Lantus is brand name for Glargine'], 'description': 'Insulin glargine given at 80% of prior stable drip rate.', 'armGroupLabels': ['80% Glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Mark E Molitch, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University Feinberg School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Mark E. Molitch, M.D.', 'oldOrganization': 'Northwestern University Feinberg School of Medicine'}}}}