Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-19 @ 2:07 AM
Study NCT ID:
NCT00574912
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2007-12-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Characteristics of Glargine in Type 2 Diabetics
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': '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': 'sdavis@medicine.umaryland.edu', 'phone': '4103282488', 'title': 'Dr. Stephen N. Davis', 'organization': 'University of Maryland, Baltimore'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo\n\nInsulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '0.5 Units of Glargine/kg Body Weight', 'description': '0.5 units of Glargine/kg body weight\n\nInsulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '1 Unit of Glargine/kg Body Weight', 'description': '1 unit of glargine/kg body weight\n\nInsulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '1.5 Units of Glargine/kg Body Weight', 'description': '1.5 units of glargine/kg body weight\n\nInsulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '2.0 Units of Glargine/kg Body Weight', 'description': '2.0 units of glargine/kg body weight\n\nInsulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Glucose Infusion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Maximum glucose infusion rate'}, {'id': 'OG001', 'title': '0.5 Units of Glargine/kg', 'description': 'maximum glucose infusion rate'}, {'id': 'OG002', 'title': '1.0 Units of Glargine/kg', 'description': 'maximum glucose infusion rate'}, {'id': 'OG003', 'title': '1.5 Units of Glargine/kg', 'description': 'maximum glucose infusion rate'}, {'id': 'OG004', 'title': '2.0 Units of Glargine/kg', 'description': 'maximum glucose infusion rate'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '6.8', 'spread': '2.0', 'groupId': 'OG003'}, {'value': '9.5', 'spread': '2.1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'measuring the changes in glucose infusion rate during the 24 hour experimental period.', 'unitOfMeasure': 'umol/kg/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '12 participants in each arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 All Interventions', 'description': 'Other: 1--All interventions\n\nAll participant will be given all 5 interventions in the same order\n\nPlacebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Completed Placebo', 'achievements': [{'comment': '12 original participants started the trial.', 'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Completed 0.5', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Completed 1.0', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Completed 1.5', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Completed 2.0', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Could not place IV lines.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'scheduling conflicts', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '12 individuals will be their own controls completing 5 separate 24 hour protocol studies. If a participant does not complete all protocols, another person will be recruited to complete the protocols until there are 12 completed studies in each arm/group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '1--All Interventions', 'description': 'Arm: Other: 1--All interventions\n\nAll participant will be given all 5 interventions in the same order\n\nPlacebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'One participant may have received more than one intervention.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-17', 'studyFirstSubmitDate': '2007-12-13', 'resultsFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2007-12-13', 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-02', 'studyFirstPostDateStruct': {'date': '2007-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Glucose Infusion Rate', 'timeFrame': '24 hours', 'description': 'measuring the changes in glucose infusion rate during the 24 hour experimental period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'Insulin Glargine', 'Endogenous Glucose Production'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '20357371', 'type': 'DERIVED', 'citation': 'Wang Z, Hedrington MS, Gogitidze Joy N, Briscoe VJ, Richardson MA, Younk L, Nicholson W, Tate DB, Davis SN. Dose-response effects of insulin glargine in type 2 diabetes. Diabetes Care. 2010 Jul;33(7):1555-60. doi: 10.2337/dc09-2011. Epub 2010 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'The study is to determine the dose response relationship of insulin glargine in type 2 diabetes over a 24-hour period and measuring the differences in glucose production among the differing doses of glargine.\n\nHypothesis: Differing doses of insulin glargine over a 24-hour period in type 2 diabetes will show differing effects on endogenous glucose production, glucose disposal and carbohydrate and lipid flux.', 'detailedDescription': 'The incidence of type 2 DM is increasing worldwide at an alarming rate. Unfortunately, the number of individuals with glycemic control at or below the American Diabetes Association goal of 7% has dropped. In fact, the number of patients with their important cardiometabolic risk factors of glucose, lipids and blood pressure at goal is only 7%. One of the reasons for this lack of metabolic control in type 2 DM is the continued relative underutilization of insulin. Diabetes is an insulin deficient state and requires appropriate physiologic replacement of insulin. Physiologic replacement of insulin requires a basal component to restrain overnight endogenous glucose production, lipolysis and proteolysis. The other component involves prandial insulin to regulate post prandial glucose levels. Recently, insulin glargine was introduced as a once-a-day peakless basal insulin. This form of basal insulin reproduces the normal constitutive physiologic release of insulin from the pancreas. Insulin glargine represents a breakthrough in treatment as the previous available "basal insulins" either produced peaks of activity (which are disadvantageous as this results in hypoglycemia) or do not last 24 hrs which results in post absorbative hyperglycemia. Despite the undoubted advantages of insulin glargine, there remains a lack of information regarding some aspects of glargine action. The study objectives are: 1) to determine the pharmacokinetic and pharmacodynamic dose response relationship of insulin glargine in Type 2 DM; 2) partition the dose response relationship of insulin glargine on endogenous glucose production and glucose uptake in Type 2 DM; and 3) to determine if the pharmacokinetic and pharmacodynamics of insulin glargine are consistent over a wide range of doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12 adults (males or females) with type 2 diabetes for at least six (6) months. May be using oral agents (SUs, metformin, acarbose or glitinides) with or without insulin.\n* HgbA1c 7 -12%\n* Age 18-70 years\n* BMI 27-40 kg/m²\n\nExclusion Criteria:\n\n* Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study\n* Evidence of hepatic, renal or cardiac failure\n* Abnormal results following screening tests\n* Pregnant or lactating females or females of childbearing potential who are unwilling to abstain from sexual intercourse or use reliable, medically accepted methods of contraception\n* Currently using TZDs\n* History of alcoholism or drug abuse within 12 months of the study'}, 'identificationModule': {'nctId': 'NCT00574912', 'briefTitle': 'Characteristics of Glargine in Type 2 Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'A Comparison of PK/PD Dose Response Characteristics of Glargine in Type 2 Diabetics', 'orgStudyIdInfo': {'id': 'IRB#060887-Lantus Glargine'}, 'secondaryIdInfos': [{'id': 'VUMC 32787'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo then Insulin Glargine', 'description': 'Placebo: administer single dose of Placebo subcutaneously (SC) with blood glucose monitoring over 24 hours.\n\nThen Insulin Glargine SQ 8 weeks later, in increasing doses (0.5, 1.0, 1.5, 2.0 u/kg body wt.) with blood glucose monitoring monitoring over a 24 hour period. Each dose is separated by 8 weeks (5 separate study visits)', 'interventionNames': ['Drug: Placebo', 'Drug: Insulin Glargine 0.5 u/kg body wt SC', 'Drug: Insulin Glargine 1.0 u/kg body wt SC', 'Drug: Insulin Glargine 1.5 u/kg body wt SC', 'Drug: Insulin Glargine 2.0 u/kg body wt SC']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Lantus'], 'description': 'single dose of Placebo injected s/c at 8am and monitor blood glucose over 24 hours', 'armGroupLabels': ['Placebo then Insulin Glargine']}, {'name': 'Insulin Glargine 0.5 u/kg body wt SC', 'type': 'DRUG', 'otherNames': ['Lantus'], 'description': '8 weeks later, a differing dose (0.5, 1.0, 1.5, 2.0 u/kg body wt.) of Insulin Glargine and monitoring over a 24 hour period each separated by 8 weeks (5 separate study visits)', 'armGroupLabels': ['Placebo then Insulin Glargine']}, {'name': 'Insulin Glargine 1.0 u/kg body wt SC', 'type': 'DRUG', 'otherNames': ['Lantus'], 'armGroupLabels': ['Placebo then Insulin Glargine']}, {'name': 'Insulin Glargine 1.5 u/kg body wt SC', 'type': 'DRUG', 'otherNames': ['Lantus'], 'armGroupLabels': ['Placebo then Insulin Glargine']}, {'name': 'Insulin Glargine 2.0 u/kg body wt SC', 'type': 'DRUG', 'otherNames': ['Lantus'], 'armGroupLabels': ['Placebo then Insulin Glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Stephen N. Davis, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman of Medicine, University of Maryland, Baltimore', 'investigatorFullName': 'Steve Davis', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}