Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-26 @ 6:52 AM
Study NCT ID:
NCT01600950
Status:
COMPLETED
Last Update Posted:
2014-10-07
First Post:
2012-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
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': 'C000606659', 'term': 'LY2963016 insulin glargine'}, {'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': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LY2963016', 'description': 'A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.', 'otherNumAtRisk': 20, 'otherNumAffected': 4, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lantus', 'description': 'A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.', 'otherNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacodynamics: Duration of Action of LY2963016 and Lantus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016', 'description': 'A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.13', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '40.5'}, {'value': '40.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '41.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Periods 1 and 2: Baseline up to 42 hours postdose', 'description': "Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently \\>150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.", 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Full Range', 'populationDescription': 'All randomized participants who received study drug during Periods 1 or 2. Participants were analyzed based on treatment they received. The numbers of participants censored were 7 for both LY2963016 and Lantus groups. Maximum duration of actions is based on participants who reached the end of action before 42 hours: 13 participants for both groups.'}, {'type': 'SECONDARY', 'title': 'Maximum Glucose Infusion Rate (Rmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016', 'description': 'A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.530', 'spread': '254', 'groupId': 'OG000'}, {'value': '0.611', 'spread': '310', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Periods 1 and 2: Baseline up to 42 hours postdose', 'description': 'Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) \\[5.6 millimoles/Liter (mmol/L)\\] and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by body weight.', 'unitOfMeasure': 'milligrams/kilogram/minute (mg/kg/min)', 'dispersionType': 'Geometric Coefficient of Variation', 'populationDescription': 'All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.'}, {'type': 'SECONDARY', 'title': 'Total Glucose Infused (Gtot)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016', 'description': 'A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.60', 'spread': '1090', 'groupId': 'OG000'}, {'value': '6.52', 'spread': '1160', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Periods 1 and 2: Baseline up to 42 hours postdose', 'description': 'Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight.', 'unitOfMeasure': 'milligrams/kilogram (mg/kg)', 'dispersionType': 'Geometric Coefficient of Variation', 'populationDescription': 'All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Glucose Infusion Rate (tRmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016', 'description': 'A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.90', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '30.1'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '29.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Periods 1 and 2: Baseline up to 42 hours postdose', 'description': 'tRmax is the time to reach maximum glucose infusion rate and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.', 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Full Range', 'populationDescription': 'All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016', 'description': 'A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.'}], 'timeFrame': 'Periods 1 and 2: Baseline up to 42 hours postdose', 'description': 'Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.', 'populationDescription': 'No participants were analyzed because of insufficient data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2963016', 'description': 'A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.'}, {'id': 'OG001', 'title': 'Lantus', 'description': 'A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.'}], 'timeFrame': 'Periods 1 and 2: Baseline up to 42 hours postdose', 'description': 'AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.', 'populationDescription': 'No participants were analyzed because of insufficient data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LY2963016/Lantus', 'description': 'A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days.\n\nA single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 2.'}, {'id': 'FG001', 'title': 'Lantus/LY2963016', 'description': 'A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days.\n\nA single 0.3 U/kg dose of LY2963016 was administered subcutaneously on Day 1 during Period 2.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This was a randomized, 2-period, 2-sequence, crossover study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'A single 0.3 units/kilogram (U/kg) dose of either LY2963016 or LANTUS was administered subcutaneously on Day 1 of Periods 1 or 2.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-03', 'studyFirstSubmitDate': '2012-05-15', 'resultsFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2012-05-15', 'lastUpdatePostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-03', 'studyFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacodynamics: Duration of Action of LY2963016 and Lantus', 'timeFrame': 'Periods 1 and 2: Baseline up to 42 hours postdose', 'description': "Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently \\>150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose."}], 'secondaryOutcomes': [{'measure': 'Maximum Glucose Infusion Rate (Rmax)', 'timeFrame': 'Periods 1 and 2: Baseline up to 42 hours postdose', 'description': 'Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) \\[5.6 millimoles/Liter (mmol/L)\\] and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by body weight.'}, {'measure': 'Total Glucose Infused (Gtot)', 'timeFrame': 'Periods 1 and 2: Baseline up to 42 hours postdose', 'description': 'Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight.'}, {'measure': 'Time of Maximum Glucose Infusion Rate (tRmax)', 'timeFrame': 'Periods 1 and 2: Baseline up to 42 hours postdose', 'description': 'tRmax is the time to reach maximum glucose infusion rate and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.'}, {'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus', 'timeFrame': 'Periods 1 and 2: Baseline up to 42 hours postdose', 'description': 'Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.'}, {'measure': 'Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus', 'timeFrame': 'Periods 1 and 2: Baseline up to 42 hours postdose', 'description': 'AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria\n* have had a duration of diabetes ≥1 year\n* have hemoglobin A1c ≤10.0%\n* have fasting C-peptide ≤0.3 nanomoles per liter (nmol/L)\n* have a body mass index ≤29 kilograms per square meter (kg/m²)\n* have venous access sufficient to allow blood sampling and cannulation for clamp procedures\n\nExclusion Criteria:\n\n* are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device\n* have a total insulin requirement \\>1.2 units per kilogram per day (U/kg/day)\n* have a history of proliferative retinopathy\n* have known allergies to insulin glargine, insulin lispro, heparin, or related compounds\n* have an electrocardiogram (ECG) reading considered outside the normal limits\n* have an abnormal blood pressure\n* have abnormal clinical laboratory tests\n* have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs\n* history of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first-degree relatives\n* show evidence of significant active neuropsychiatric disease\n* regular use of known drugs of abuse and/or show positive findings on drug screening\n* show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies\n* show evidence of hepatitis C and/or positive hepatitis C antibody\n* show evidence of hepatitis B and/or positive hepatitis B surface antigen\n* are women with a positive pregnancy test or women who are lactating\n* have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females)\n* had more than 1 episode of severe hypoglycemia within 6 months prior to study\n* undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer\n* had a blood transfusion or severe blood loss within 3 months; made a blood donation within 30 days prior to study entry; or have known hemoglobinopathy, haemolytic anemia, or sickle cell anemia\n* are receiving systemic glucocorticoid therapy\n* have irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night)\n* show a history of adverse reactions to heparin, including heparin-induced thrombocytopenia\n* smoke more than 10 cigarettes (or equivalent other tobacco products) per day'}, 'identificationModule': {'nctId': 'NCT01600950', 'briefTitle': 'A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Pharmacodynamics of LY2963016 Compared to LANTUS® in Subjects With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '13831'}, 'secondaryIdInfos': [{'id': 'I4L-MC-ABEE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2963016', 'description': 'A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days.', 'interventionNames': ['Drug: LY2963016']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lantus', 'description': 'A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.', 'interventionNames': ['Drug: Lantus']}], 'interventions': [{'name': 'LY2963016', 'type': 'DRUG', 'description': 'Single 0.3 U/kg dose administered subcutaneously', 'armGroupLabels': ['LY2963016']}, {'name': 'Lantus', 'type': 'DRUG', 'description': 'Single 0.3 U/kg dose administered subcutaneously', 'armGroupLabels': ['Lantus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}