Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 8:27 PM
Study NCT ID:
NCT01676233
Status:
COMPLETED
Last Update Posted:
2013-08-19
First Post:
2012-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus
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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-16', 'studyFirstSubmitDate': '2012-08-28', 'studyFirstSubmitQcDate': '2012-08-29', 'lastUpdatePostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 24-hour blood glucose profile measured by continuous glucose monitoring', 'timeFrame': 'Baseline, Day 28, Day 56'}], 'secondaryOutcomes': [{'measure': 'Hypoglycemia categorized by the definition of American Diabetes Association', 'timeFrame': 'Up to Day 56'}, {'measure': 'Change in fasting plasma glucose from baseline to each treatment end by treatment', 'timeFrame': 'Baseline, Day 28, Day 56'}, {'measure': 'Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment', 'timeFrame': 'Baseline, Day 28, Day 56'}, {'measure': 'Change in HbA1c from baseline to each treatment end by treatment', 'timeFrame': 'Baseline, Day 28, Day 56'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '26055218', 'type': 'DERIVED', 'citation': 'Jinnouchi H, Koyama M, Amano A, Takahashi Y, Yoshida A, Hieshima K, Sugiyama S, Kurinami N, Jinnouchi T, Becker R. Continuous Glucose Monitoring During Basal-Bolus Therapy Using Insulin Glargine 300 U mL(-1) and Glargine 100 U mL (-1) in Japanese People with Type 1 Diabetes Mellitus: A Crossover Pilot Study. Diabetes Ther. 2015 Jun;6(2):143-52. doi: 10.1007/s13300-015-0115-1. Epub 2015 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n\\- To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state\n\nSecondary Objectives:\n\n* To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;\n* To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));\n* To compare the occurrence of hypoglycemia between the 2 treatments;\n* To assess the safety and tolerability of a new formulation of insulin glargine.', 'detailedDescription': '66 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Japanese patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus insulin;\n\nExclusion criteria:\n\n* Age \\< 20 years at written informed consent;\n* HbA1c \\< 6.5% or \\> 10.0% at screening\n* Diabetes mellitus (DM) other than T1DM;\n* Body Mass Index (BMI) \\> 35.0 kg/m2 at screening visit\n* Any contraindication to use of insulin glargine as defined in the Japanese Package Insert\n* Hypoglycemia unawareness or history of metabolic acidosis, including hospitalization for diabetic ketoacidosis during the 24 weeks prior to screening visit\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01676233', 'briefTitle': 'Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Open-label, 2-treatment Crossover Study of a New Formulation of Insulin Glargine Comparing to Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus on Treatment With Basal-bolus Insulin', 'orgStudyIdInfo': {'id': 'PDY12335'}, 'secondaryIdInfos': [{'id': 'U1111-1129-3633', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal', 'interventionNames': ['Drug: insulin glargine (HOE901)', 'Drug: insulin glargine- new formulation (HOE901)']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal', 'interventionNames': ['Drug: insulin glargine (HOE901)', 'Drug: insulin glargine- new formulation (HOE901)']}], 'interventions': [{'name': 'insulin glargine (HOE901)', 'type': 'DRUG', 'description': 'Pharmaceutical form: solution Route of administration: subcutaneous', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}, {'name': 'insulin glargine- new formulation (HOE901)', 'type': 'DRUG', 'description': 'Pharmaceutical form: solution Route of administration: subcutaneous', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Investigational Site Number 392001', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}