Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT00405418
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2006-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lantus Versus Levemir Treat-To-Target
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia and Montenegro']}, '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': 'D000069057', 'term': 'Insulin Detemir'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 973}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'lastUpdateSubmitDate': '2009-09-14', 'studyFirstSubmitDate': '2006-11-29', 'studyFirstSubmitQcDate': '2006-11-29', 'lastUpdatePostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c recorded', 'timeFrame': 'At baseline, week 12 and week 24'}, {'measure': 'Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm', 'timeFrame': 'On the 4 consecutive days before each visit'}, {'measure': 'Self-monitored BG values from 8-point 24-hour profile recorded on 2 consecutive days', 'timeFrame': 'Within the week prior to baseline, week 12 and week 24'}, {'measure': 'Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic)', 'timeFrame': 'All across the study'}, {'measure': 'Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia.', 'timeFrame': 'All across the study'}], 'secondaryOutcomes': [{'measure': 'Doses of insulin glargine or insulin detemir', 'timeFrame': 'Daily'}, {'measure': 'Laboratory fasting plasma glucose', 'timeFrame': 'At baseline, week 12 and week 24'}, {'measure': 'Insulinemia and fasting C-peptide level', 'timeFrame': 'At baseline'}, {'measure': 'Lipid profile', 'timeFrame': 'at baseline and week 24'}, {'measure': 'Patient reported outcomes (quality of life and treatment satisfaction)', 'timeFrame': 'at baseline, week 4, week 12 and at the last visit'}, {'measure': 'Safety data: occurrence of adverse events and weight', 'timeFrame': 'assessed at each visit'}, {'measure': 'Waist and hip circumferences', 'timeFrame': 'measured at baseline, week 12 and week 24'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': 'measured at study entry, baseline, week 12 and week 24'}, {'measure': 'Physical examination', 'timeFrame': 'performed at study entry and at last visit.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '20200301', 'type': 'DERIVED', 'citation': 'Swinnen SG, Dain MP, Aronson R, Davies M, Gerstein HC, Pfeiffer AF, Snoek FJ, Devries JH, Hoekstra JB, Holleman F. A 24-week, randomized, treat-to-target trial comparing initiation of insulin glargine once-daily with insulin detemir twice-daily in patients with type 2 diabetes inadequately controlled on oral glucose-lowering drugs. Diabetes Care. 2010 Jun;33(6):1176-8. doi: 10.2337/dc09-2294. Epub 2010 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\nTo demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c \\< 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L)\n\nSecondary objectives:\n\n* To compare between the 2 treatment groups, the percentage of patients who reach the target of HbA1c \\< 7% and \\< 6.5% at the end of the treatment period\n* To compare the changes in HbA1c and fasting plasma glucose (FPG)\n* To compare the evolution of blood glucose profiles\n* To compare the day to day FPG variability, the insulin doses\n* To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets\n* To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L)\n* To compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL \\[3.9 mmol/L\\]), of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL\n* To compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio\n* To assess the quality of life and treatment satisfaction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 diabetes for at least 1 year\n* Insulin naïve\n* Treated with stable doses of oral antidiabetics for at least 3 months prior to study start, including at least metformin (at least 1g/day)\n* 7% ≤ HbA1c ≤ 10.5 %\n* Body mass index (BMI) \\< 40 kg/m²\n* Ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week)\n* Treatment with glucagon-like peptide (GLP)-1 receptor agonists or with dipeptidyl peptidase (DPP)-IV inhibitors\n* Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)\n* Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)\n* Breast-feeding\n* History of hypersensitivity to the study drugs or to drugs with a similar chemical structure\n* Treatment with systemic corticosteroids in the 3 months prior to study entry\n* Treatment with any investigational product in the 2 months prior to study entry\n* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol\n* Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult\n* Impaired hepatic function as shown by Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry\n* Impaired renal function as shown by serum creatinine ≥ 1.5 mg/dL (≥ 133 μmol/L) in men and ≥ 1.4 mg/dL (124 μmol/L) in women at study entry\n* History of drug or alcohol abuse in the last year\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00405418', 'acronym': 'L2T3', 'briefTitle': 'Lantus Versus Levemir Treat-To-Target', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Target Glycemic Control and the Incidence of Documented Symptomatic Hypoglycemia in Insulin naïve Subjects With Type 2 Diabetes Failing on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or Insulin Detemir.', 'orgStudyIdInfo': {'id': 'LANTU_C_00579'}, 'secondaryIdInfos': [{'id': 'EUDRACT # : 2006-000324-13'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Insulin Glargine', 'interventionNames': ['Drug: Insulin glargine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Insulin Detemir', 'interventionNames': ['Drug: Insulin Detemir']}], 'interventions': [{'name': 'Insulin glargine', 'type': 'DRUG', 'description': 'Subcutaneous injection, once a day in the evening', 'armGroupLabels': ['1']}, {'name': 'Insulin Detemir', 'type': 'DRUG', 'description': 'Subcutaneous injection, twice a day at breakfast and before dinner', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'North Ryde', 'country': 'Australia', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': -33.79677, 'lon': 151.12436}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Hoersholm', 'country': 'Denmark', 'facility': 'Sanofi-Aventis'}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'city': 'Porto Salvo', 'country': 'Portugal', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 38.72293, 'lon': -9.30473}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Meyrin', 'country': 'Switzerland', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 46.23424, 'lon': 6.08025}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Guildford', 'country': 'United Kingdom', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'overallOfficials': [{'name': 'Valérie Pilorget', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}