Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 5:03 AM
Study NCT ID:
NCT00606034
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2008-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mountaindiabetes@msn.com', 'phone': '828-258-2404', 'title': 'Dr. Wendy Lane, Director of Clinical Research', 'phoneExt': '314', 'organization': 'Mountain Diabetes and Endocrine Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size. Also an uncontrolled pilot study.'}}, 'adverseEventsModule': {'timeFrame': '1 Year', 'description': 'Subjects will be assessed for adverse events at each study visit and will report serious adverse events via the 24 hour contact number.', 'eventGroups': [{'id': 'EG000', 'title': 'All Subjects Active', 'description': 'All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Hypoglycemia', 'notes': '1 subject experienced a hypoglycemic event of 39mg/dl which required emergency assistance. The outcome of the event is recovered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects Using U-500 Regular Insulin Via Omnipod', 'description': 'All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.23', 'spread': '1.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'HbA1c is expressed as a percentage. This measurement represents an average of plasma glucose concentration for about 3 months. We will report the change in HbA1c measured at 12 months vs Baseline.', 'unitOfMeasure': 'HbA1c percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent in Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.7', 'spread': '4.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline versus 12 months', 'description': 'For the purposed of this study, hypoglycemia is defined as a blood glucose measurement of less than 70 mg/dl. As part of of this study, subjects will wear a Continuous Glucose Monitor (CGM) for 72 hours to assess glycemic control. The percent of time in hypoglycemia is a part of the download from the CGM.', 'unitOfMeasure': 'percent of time spent in hypoglycemia', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (LOCF for 1 subject)'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'All subjects will receive the IDRSQ at baseline and at Week 52'}], 'classes': [{'categories': [{'measurements': [{'value': '90.68', 'spread': '8.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline versus 1 year', 'description': 'Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.', 'unitOfMeasure': 'percent satisfaction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subjects Active', 'description': 'All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects recruited between Dec 2008 and Dec 2009 from clinic at Mountain Diabetes and Endocrine Center.', 'preAssignmentDetails': 'Patients who had failed any previous insulin regimen with HbA1c over 7% and requiring over 100 units of insulin per day were enrolled and switched to treatment with U500 insulin via Omnipod.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects Active', 'description': 'All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.86', 'spread': '11.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-07', 'studyFirstSubmitDate': '2008-01-19', 'resultsFirstSubmitDate': '2012-07-26', 'studyFirstSubmitQcDate': '2008-01-31', 'lastUpdatePostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-08', 'studyFirstPostDateStruct': {'date': '2008-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)', 'timeFrame': '1 year', 'description': 'HbA1c is expressed as a percentage. This measurement represents an average of plasma glucose concentration for about 3 months. We will report the change in HbA1c measured at 12 months vs Baseline.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Time Spent in Hypoglycemia', 'timeFrame': 'baseline versus 12 months', 'description': 'For the purposed of this study, hypoglycemia is defined as a blood glucose measurement of less than 70 mg/dl. As part of of this study, subjects will wear a Continuous Glucose Monitor (CGM) for 72 hours to assess glycemic control. The percent of time in hypoglycemia is a part of the download from the CGM.'}, {'measure': 'Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)', 'timeFrame': 'Baseline versus 1 year', 'description': 'Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'Insulin Resistance', 'Continuous Subcutaneous Insulin Infusion', 'U-500 Insulin', 'Omnipod'], 'conditions': ['Type 2 Diabetes', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '16772195', 'type': 'BACKGROUND', 'citation': 'Lane WS. Use of U-500 regular insulin by continuous subcutaneous insulin infusion in patients with type 2 diabetes and severe insulin resistance. Endocr Pract. 2006 May-Jun;12(3):251-6. doi: 10.4158/EP.12.3.251.'}]}, 'descriptionModule': {'briefSummary': 'Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump.', 'detailedDescription': 'Patients with Type 2 diabetes who have severe insulin resistance and very large insulin requirements (over 1.4 units of insulin /kg/day) often fail insulin regimens with persistent poor blood glucose control when standard U-100 insulin formulations are used. This is due in part to poor absorption of the large insulin volumes required using these less concentrated standard insulin preparations. The hypothesis that using a concentrated form of insulin called U-500 Regular insulin and delivering it by infusion via insulin pump will lower the volume of insulin required and therefore improve insulin absorption, which will lead to improved blood glucose control, will be tested.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes on stable insulin regimen with or without oral agents for at least 3 months\n* HbA1c \\> 7%\n* No significant cardiovascular, renal or other serious medical diseases\n\nExclusion Criteria:\n\n* HbA1c \\< 7%\n* Chronic renal, hepatic, cardiovascular, or other serious medical illness\n* Females of childbearing age not using adequate contraception\n* Use of GLP mimetic'}, 'identificationModule': {'nctId': 'NCT00606034', 'briefTitle': 'U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod', 'organization': {'class': 'OTHER', 'fullName': 'Mountain Diabetes and Endocrine Center'}, 'officialTitle': 'A Prospective Trial of U500 Regular Insulin by Continuous Subcutaneous Insulin Infusion in Patients With Type 2 Diabetes and Severe Insulin Resistance Who Have Failed Previous Insulin Regimens', 'orgStudyIdInfo': {'id': 'U-500R'}, 'secondaryIdInfos': [{'id': 'U500'}, {'id': 'B5K-US-X009'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All subjects active', 'description': 'All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.', 'interventionNames': ['Drug: U-500 Insulin delivered by Omnipod (disposable insulin pump)']}], 'interventions': [{'name': 'U-500 Insulin delivered by Omnipod (disposable insulin pump)', 'type': 'DRUG', 'description': "U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs", 'armGroupLabels': ['All subjects active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mountain Diabetes and Endocrine Center', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}], 'overallOfficials': [{'name': 'Wendy S Lane, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mountain Diabetes and Endocrine Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mountain Diabetes and Endocrine Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research, Principal Investigator', 'investigatorFullName': 'Wendy Lane MD', 'investigatorAffiliation': 'Mountain Diabetes and Endocrine Center'}}}}