Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT01204593
Status:
COMPLETED
Last Update Posted:
2014-03-17
First Post:
2010-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
baSal BoluS Therapy in 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'}, {'id': 'C479079', 'term': 'insulin glulisine'}], '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-14', 'studyFirstSubmitDate': '2010-09-16', 'studyFirstSubmitQcDate': '2010-09-16', 'lastUpdatePostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC))', 'timeFrame': 'between baseline (week 0) and endpoint (week 24)'}], 'secondaryOutcomes': [{'measure': 'Change of HbA1c', 'timeFrame': 'from baseline to week 12'}, {'measure': 'Percentage of patients with HbA1c < 7%', 'timeFrame': 'at week 12 and week 24'}, {'measure': 'Fasting Blood Glucose (FBG)', 'timeFrame': 'at baseline, week 12 and week 24'}, {'measure': '7-point Self Monitoring of Blood Glucose (SMBG)', 'timeFrame': 'at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days)'}, {'measure': 'Daily dose for insulin glulisine', 'timeFrame': 'At baseline, week 12 and week 24'}, {'measure': 'Daily dose for insulin glargine', 'timeFrame': 'At baseline, week 12 and week 24'}, {'measure': 'Symptomatic hypoglycemias', 'timeFrame': 'From baseline (week 0) to endpoint (week 24)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM).\n\nSecondary Objectives:\n\nTo evaluate:\n\n* The change of hemoglobin A1c (HbA1c) from baseline to week 12\n* The percentage of patients with HbA1c \\< 7% at week 12 and week 24\n* The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24\n* The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24\n* The incidence of symptomatic hypoglycemias\n* Adverse events', 'detailedDescription': 'After a two-week run-in period patients will enter a six-month treatment period.\n\nEstimated study duration per patient : 26 weeks (including a 2-week run-in period).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Known Type 1 diabetic patients (male or female) treated with any type of insulin regimen, except:\n\n * continuous subcutaneous insulin infusion (CSII, or pump), and\n * patients already treated with insulin glargine\n2. Age: 18-60 years inclusive\n3. HbA1c: 8% - 10% assessed over the past 6 month\n4. At least 1 year of continuous insulin treatment\n5. Willingness to accept, and ability to follow:\n\n * a basal bolus regimen (glargine x1 and glulisine x3 per day),\n * self-monitoring blood glucose (SMBG)\n * a fixed meal plan, or CHO counting\n6. Signed informed consent obtained prior to any study procedure\n\nCriteria for entry in the treatment period:\n\n1. HbA1c 8-10% assessed between week -2 and week 0\n2. Serum creatinine ≤135 micromol/L in men and ≤110 micromol/L in women\n3. Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) lower or equal to three times the upper limit of normal\n4. Pregnancy test negative if women of childbearing potential\n\nExclusion criteria:\n\n1. History of hypersensitivity to insulin glargine and/or insulin glulisine\n2. Pregnant, breast-feeding or women of childbearing potential not using efficient contraception\n3. Brittle diabetes\n4. Known impaired renal function defined as serum creatinine \\> 135 micromol/L in men and \\> 110 micromol/L in women at study entry\n5. Known impaired hepatic function defined as Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal at study entry\n6. Diabetes ketoacidosis\n7. History of drug or alcohol abuse\n8. Psychiatric or mental disease\n9. Inclusion in another study in the past 6 months or previous inclusion in this study\n10. Patient unable or unwilling to manage properly the basal bolus regimen\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01204593', 'acronym': 'SUBSTITUTE', 'briefTitle': 'baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Phase IV, Multicenter, International, Non-comparative, Open Label Study of Efficacy and Safety of Basal Bolus Therapy (Insulin Glargine + Insulin Glulisine) in Patients With T1 Diabetes Previously Uncontrolled on Any Insulin Regimen.', 'orgStudyIdInfo': {'id': 'LANTU_R_05033'}, 'secondaryIdInfos': [{'id': 'U1111-1116-3450', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin glargine + insulin glulisine', 'description': 'Insulin glargine dosage will be individually titrated once a week to obtain FPG 80-120 mg/dL (4.5-6.7 mmol/L).\n\nInsulin glulisine dosage will be individually titrated once a week to obtain a 2-hour postprandial plasma glucose (PPG) \\< 180 mg/dL (\\<10.0 mmol/L) and ideally around 140 mg/dL.', 'interventionNames': ['Drug: INSULIN GLARGINE', 'Drug: INSULIN GLULISINE']}], 'interventions': [{'name': 'INSULIN GLARGINE', 'type': 'DRUG', 'otherNames': ['Lantus SoloStar'], 'description': 'Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day at bedtime', 'armGroupLabels': ['Insulin glargine + insulin glulisine']}, {'name': 'INSULIN GLULISINE', 'type': 'DRUG', 'otherNames': ['Apidra SoloStar'], 'description': 'Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal', 'armGroupLabels': ['Insulin glargine + insulin glulisine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Algeries', 'country': 'Algeria', 'facility': 'Investigational Site Number 01201'}, {'city': 'Algiers', 'country': 'Algeria', 'facility': 'Investigational Site Number 01202', 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'city': 'Algiers', 'country': 'Algeria', 'facility': 'Investigational Site Number 01203', 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'city': 'Algiers', 'country': 'Algeria', 'facility': 'Investigational Site Number 01204', 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'city': 'Caba', 'country': 'Argentina', 'facility': 'Investigational Site Number 03201'}, {'city': 'Caba', 'country': 'Argentina', 'facility': 'Investigational Site Number 03202'}, {'city': 'Caba', 'country': 'Argentina', 'facility': 'Investigational Site Number 03203'}, {'city': 'Caba', 'country': 'Argentina', 'facility': 'Investigational Site Number 03204'}, {'city': 'Morón', 'country': 'Argentina', 'facility': 'Investigational Site Number 03205', 'geoPoint': {'lat': -34.65118, 'lon': -58.62205}}, {'zip': '80540-010', 'city': 'Curitiba', 'country': 'Brazil', 'facility': 'Investigational Site Number 076-007', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '71625-009', 'city': 'Distrito Federal', 'country': 'Brazil', 'facility': 'Investigational Site Number 076-003'}, {'zip': '60430-370', 'city': 'Fortaleza', 'country': 'Brazil', 'facility': 'Investigational Site Number 076-010', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '17519-101', 'city': 'Marília', 'country': 'Brazil', 'facility': 'Investigational Site Number 076-006', 'geoPoint': {'lat': -22.21389, 'lon': -49.94583}}, {'zip': '91350-250', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Investigational Site Number 076-004', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '01244-030', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Investigational Site Number 076-002', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Barranquilla', 'country': 'Colombia', 'facility': 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