Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-24 @ 12:56 PM
Study NCT ID:
NCT00653302
Status:
COMPLETED
Last Update Posted:
2008-12-03
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)
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'}, {'id': 'D008687', 'term': 'Metformin'}], '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'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-02', 'studyFirstSubmitDate': '2008-04-01', 'studyFirstSubmitQcDate': '2008-04-03', 'lastUpdatePostDateStruct': {'date': '2008-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).', 'timeFrame': 'During the study conduct'}], 'secondaryOutcomes': [{'measure': 'Determination of the predictive criterion of HbA1c final', 'timeFrame': 'During the study conduct'}, {'measure': 'Determination of the predictive criterion of weight variation', 'timeFrame': 'During all the study conduct'}, {'measure': 'HbA1c and weight variations (final value - basal value)', 'timeFrame': 'during the study'}, {'measure': 'AE/SAE evaluation', 'timeFrame': 'from the informed consent signed up to the end of the study'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\n* Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c\\<7% and/or a final decrease of HbA1c\\>15% compare to the basal value (HbA1c final - HbA1c basal).\n\nSecondary objectives:\n\n* Determination of the predictive criterion of HbA1c final,\n* Determination of the predictive criterion of weight variation,\n* Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders),\n* Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value).\n\nSafety:\n\n* Adverse Event (AE)/Serious Adverse Event (SAE) assessments'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known type 2 diabetes for at least 2 years\n* No history of Ketoacidosis\n* BMI\\> 25 \\& \\<35 kg/m2\n* Type 2 diabetes treated with oral bi or tritherapy for at least 6 months\n\n * With insulin release stimulator: sulfonamide or glinide at maximal posology (as defined in the SmPC),\n * and metformin at minimal posology 1700mg/day (1320 mg of metformin),\n* HbA1c \\>= 7.5 and \\<11% for 2 different dosages during the last year\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Glucophage intolerability\n* Pregnancy\n* Breast feeding\n* Partial pancreatectomy\n* Hypersensitivity to insulin glargine excipient\n* Renal failure with creatinin\\>135 µmol/L for male and \\>110 µmol/L for female patient\n* Hepatitis with transaminases \\>3ULN\n* Pre-proliferative or proliferative retinopathy\n* Acute cardiovascular accident within the last 6 months\n* Previous treatment with insulin within the last 6 months before randomization'}, 'identificationModule': {'nctId': 'NCT00653302', 'acronym': 'GALATEE', 'briefTitle': 'Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Assessment of the Phenotype of the Type 2 Diabetic Responders to the First Insulinisation Using Lantus (Insulin Glargine) Plus Glucophage (Metformin) Combination After Failure in OADs Treatment', 'orgStudyIdInfo': {'id': 'HOE901_4043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Lantus once a day plus Glucophage 1000mg, twice a day per os', 'interventionNames': ['Drug: Lantus (insulin glargine) + Glucophage (Metformin)']}], 'interventions': [{'name': 'Lantus (insulin glargine) + Glucophage (Metformin)', 'type': 'DRUG', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-aventis administrative office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Nathalie Billon', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi-aventis administrative office France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Nathalie Billon/Study Director', 'oldOrganization': 'sanofi-aventis France'}}}}