Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT02273258
Status:
COMPLETED
Last Update Posted:
2014-10-23
First Post:
2014-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C000623163', 'term': 'SAR342434'}, {'id': 'D061268', 'term': 'Insulin Lispro'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-21', 'studyFirstSubmitDate': '2014-10-21', 'studyFirstSubmitQcDate': '2014-10-21', 'lastUpdatePostDateStruct': {'date': '2014-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog', 'timeFrame': '12 hours'}, {'measure': 'Area under the concentration versus time curve (AUC) of SAR342434, US-approved Humalog and EU-approved Humalog', 'timeFrame': '12 hours'}, {'measure': 'Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12)', 'timeFrame': '12 hours'}], 'secondaryOutcomes': [{'measure': 'The fractional area under the concentration versus time curve from 0 or y to x hours post administration (INS-AUC0 or Y to X)', 'timeFrame': '12 hours'}, {'measure': 'Time to 20% of AUC (t20%-AUC)', 'timeFrame': '12 hours'}, {'measure': 'NS-tmax, INS-t1/2z', 'timeFrame': '12 hours'}, {'measure': 'The fractional area under the body weight standardized GIR versus time curve from 0 or y to x hours post administration (GIR-AUC0 or Y to X)', 'timeFrame': '12 hours'}, {'measure': 'Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h)', 'timeFrame': '12 hours'}, {'measure': 'Maximum smoothed body weight standardized GIR (GIRmax)', 'timeFrame': '12 hours'}, {'measure': 'Time to GIRmax (GIR-tmax)', 'timeFrame': '12 hours'}, {'measure': 'Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)', 'timeFrame': '12 hours'}, {'measure': 'Number of patients with AEs, SAEs, laboratory, vital signs and electrocardiographic abnormalities , injections site reaction assessment (ISR), and if any, hypoglycemia', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.\n\nSecondary Objective:\n\nTo assess the safety and tolerability of SAR342434.', 'detailedDescription': 'The total study duration for a screened subject will be about 3 - 8 weeks (min-max duration, excl. screening)\n\n* Screening: 2 to 28 days (D -28 to D -2)\n* Treatment period 1 - 3: 2 days (1 overnight stay)\n* Washout: 5 - 18 days (preferentially 7 days between consecutive dosing)\n* End-of-study visit: 1 day between D 5 and D14 after last administration of investigational product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Male or female subjects with diabetes mellitus type 1 for more than one year.\n* Total insulin dose of \\< 1.2 U/kg/day.\n* Fasting negative serum C-peptide (\\< 0.3 nmol/L).\n* Glycohemoglobin (HbA1c) ≤ 9%.\n* Stable insulin regimen for at least 2 months prior to study.\n* Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab.\n\nExclusion criteria:\n\n* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.\n* More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.\n* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month.\n* Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.\n* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.\n* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.\n* Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of insulins, thyroid hormones, lipid-lowering and antihypertensive drugs and if female with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days.\n* Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab.\n* Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02273258', 'briefTitle': 'A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-Blind, Controlled, Single-Dose, 3-Treatment, 3-Period, 6-Sequence Crossover Study to Compare Exposure and Activity of SAR342434 to Humalog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PDY12704'}, 'secondaryIdInfos': [{'id': '2012-004453-86'}, {'id': 'U1111-1134-4816', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test (T)', 'description': 'SAR342434: single dose injection', 'interventionNames': ['Drug: SAR342434']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference 1 (R1)', 'description': 'US-approved Humalog®: single dose injection', 'interventionNames': ['Drug: Insulin Lispro']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference 2 (R2)', 'description': 'EU-approved Humalog®: single dose injection', 'interventionNames': ['Drug: Insulin Lispro']}], 'interventions': [{'name': 'SAR342434', 'type': 'DRUG', 'description': 'Pharmaceutical form:solution Route of administration: subcutaneous', 'armGroupLabels': ['Test (T)']}, {'name': 'Insulin Lispro', 'type': 'DRUG', 'description': 'Pharmaceutical form:solution Route of administration: subcutaneous', 'armGroupLabels': ['Reference 1 (R1)']}, {'name': 'Insulin Lispro', 'type': 'DRUG', 'description': 'Pharmaceutical form:solution Route of administration: subcutaneous', 'armGroupLabels': ['Reference 2 (R2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Sanofi Administrative Office', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}