Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT01127269
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2010-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-16', 'studyFirstSubmitDate': '2010-05-19', 'studyFirstSubmitQcDate': '2010-05-19', 'lastUpdatePostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no severe documented nocturnal hypoglycemia episode.', 'timeFrame': 'From week 0 (baseline) to week 24 (end of study)'}], 'secondaryOutcomes': [{'measure': 'Glycosylated Haemoglobin (HbA1c)', 'timeFrame': 'From week 0 (baseline) to week 24 (end of study)'}, {'measure': 'Dose and timing of insulin glargine', 'timeFrame': 'From week 0 (baseline) to week 24 (end of study)'}, {'measure': 'Hypoglycemic episodes', 'timeFrame': 'From week 0 (baseline) to week 24 (end of study)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nPercentage of patients achieving Glycosylated Hemoglobin (HbA1c) \\< 7% with no severe or nocturnal hypoglycemic episodes at 6 months\n\nSecondary Objectives:\n\n* Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months\n* Insulin glargine dose at 3 and 6 months\n* Hypoglycemic episodes (all types)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients with a diagnosis of type 2 diabetes for more than 6 months\n* Patients treated with Oral AntiDiabetics (OADs monotherapy or combination) with an HbA1c \\>7% and \\<10% and/or treated with NPH insulin with HbA1c \\>7% and \\<10% or treated with NPH insulin who have experienced severe and/or nocturnal hypoglycemia in the last 6 months.\n* Ability to perform SMBS and insulin self-titration under the physicians guidance.\n* Body Mass Index (BMI) \\>21 kg/ m2.\n* Signature of informed consent.\n\nExclusion criteria:\n\n* Hospitalized patients.\n* Pregnant women or with the intention of becoming pregnant.\n* Unexplained weight loss of more than 10% in the last 6 months.\n* Women with child bearing potential not using effective contraceptive methods.\n* Women in breast feeding period.\n* Patients on chronic treatment with systemic corticosteroids or protease inhibitors.\n* History of drug or alcohol abuse.\n* Diabetic retinopathy with surgical treatment in 3 months previous to study entry or patients that could require surgical treatment in the following 6 months to study entry.\n* Major systemic disease clinically important that would interfere with implementation or interpretation of the study, at the discretion of the investigator.\n* Renal failure known as creatinine \\> 1.4 mg/dl in women and \\> 1.5 mg/dl in men.\n* Known hypersensitivity to glargine or any of its excipients.\n* Patients with history of hospitalization due to cardiovascular event, cardiovascular procedure in the past 6 months.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01127269', 'acronym': 'AFICIONADO', 'briefTitle': 'Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Practical Implementation of ADA/EASD Consensus Algorithm in Patients With Type 2 Diabetes: Timely Insulin Initiation and Titration', 'orgStudyIdInfo': {'id': 'LANTU_L_04980'}, 'secondaryIdInfos': [{'id': 'U1111-1116-9268', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Glargine', 'description': 'Patients will receive insulin glargine titrated based on standard of care as recommended by the ADA/EASD Consensus Algorithm. Step 1: insulin glargine initiation regimen for insulin naive patients/ Switch to insulin glargine for patient already treated with basal insulin.\n\nStep 2: the insulin dosage of patients will be titrated according to the ADA/EASD Consensus Algorithm.', 'interventionNames': ['Drug: INSULIN GLARGINE']}], 'interventions': [{'name': 'INSULIN GLARGINE', 'type': 'DRUG', 'description': 'Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)', 'armGroupLabels': ['Insulin Glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1050AAK', 'city': 'C.a.b.a.', 'country': 'Argentina', 'facility': 'Investigational Site Number 10'}, {'zip': 'C1419AHN', 'city': 'C.a.b.a.', 'country': 'Argentina', 'facility': 'Investigational Site Number 14'}, {'city': 'C.a.b.a.', 'country': 'Argentina', 'facility': 'Investigational Site Number 01'}, {'city': 'C.a.b.a.', 'country': 'Argentina', 'facility': 'Investigational Site Number 11'}, {'city': 'C.a.b.a.', 'country': 'Argentina', 'facility': 'Investigational Site Number 12'}, {'city': 'C.a.b.a.', 'country': 'Argentina', 'facility': 'Investigational Site Number 17'}, {'city': 'C.a.b.a.', 'country': 'Argentina', 'facility': 'Investigational Site Number 9'}, {'city': 'Caba', 'country': 'Argentina', 'facility': 'Investigational Site Number 03'}, {'city': 'Caba', 'country': 'Argentina', 'facility': 'Investigational Site Number 06'}, {'city': 'Caba', 'country': 'Argentina', 'facility': 'Investigational Site Number 15'}, {'city': 'Caba', 'country': 'Argentina', 'facility': 'Investigational Site Number 16'}, {'city': 'Caba', 'country': 'Argentina', 'facility': 'Investigational Site Number 18'}, {'city': 'Capital Federal', 'country': 'Argentina', 'facility': 'Investigational Site Number 26'}, {'zip': '7600', 'city': 'Mar del Plata', 'country': 'Argentina', 'facility': 'Investigational Site Number 22', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'zip': 'B7602CBM', 'city': 'Mar del Plata', 'country': 'Argentina', 'facility': 'Investigational Site Number 13', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'city': 'Mar del Plata', 'country': 'Argentina', 'facility': 'Investigational Site Number 02', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'city': 'Moreno -Pcia. de Bs. As.-', 'country': 'Argentina', 'facility': 'Investigational Site Number 021'}, {'city': 'Morón', 'country': 'Argentina', 'facility': 'Investigational Site Number 07', 'geoPoint': {'lat': -34.65118, 'lon': -58.62205}}, {'city': 'Paraná', 'country': 'Argentina', 'facility': 'Investigational Site Number 04', 'geoPoint': {'lat': -31.73271, 'lon': -60.52897}}, {'city': 'Salta', 'country': 'Argentina', 'facility': 'Investigational Site Number 8', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'city': 'Sarandí', 'country': 'Argentina', 'facility': 'Investigational Site Number 05', 'geoPoint': {'lat': -29.74341, 'lon': -58.05953}}, {'zip': '7000', 'city': 'Tandil', 'country': 'Argentina', 'facility': 'Investigational Site Number 20', 'geoPoint': {'lat': -37.3287, 'lon': -59.1369}}, {'zip': '2800', 'city': 'Zárate', 'country': 'Argentina', 'facility': 'Investigational Site Number 25', 'geoPoint': {'lat': -34.09584, 'lon': -59.02423}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}