Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-12 @ 5:18 PM
Study NCT ID:
NCT01699932
Status:
COMPLETED
Last Update Posted:
2014-05-08
First Post:
2012-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-07', 'studyFirstSubmitDate': '2012-09-26', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'from baseline to week 24'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with HbA1c < 7%', 'timeFrame': 'at week 24'}, {'measure': 'Percentage of patients with HbA1c < 6.5%', 'timeFrame': 'at week 24'}, {'measure': 'Change in Fasting Plasma Glucose (FPG)', 'timeFrame': 'from baseline to week 24'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'over the 24-week treatment period'}, {'measure': 'Hypoglycemia', 'timeFrame': 'over the 24-week treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n-To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus.\n\nSecondary Objective:\n\nTo assess the effects of the fixed combination of glimepiride and metformin at week 24 on:\n\n* Percentage of patients reaching HbA1c \\<7%\n* Percentage of patients reaching HbA1c \\<6.5%.\n* Fasting Plasma Glucose (FPG)\n* Safety and tolerability', 'detailedDescription': 'The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period and 3 days follow-up period with a last call phone visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients with type 2 diabetes mellitus inadequately controlled despite a treatment with sulfonylurea (SU) alone or metformin alone or a free combination of SU and metformin prior to the study entry.\n* Signed informed consent, obtained prior any study procedure\n\nExclusion criteria:\n\n* Age \\< legal age of adulthood\n* HbA1c \\< 7% or ≥ 11%\n* BMI \\> 35 kg/m2\n* Treatment with a stable dose of maximally tolerated SU alone or metformin alone or the free combination of SU and metformin for less than 12 weeks prior to the screening visit.\n* Patients who received any anti-diabetic drug other than SU or metformin within 12 weeks prior to the screening visit.\n* Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake…)\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01699932', 'acronym': 'LEGEND', 'briefTitle': 'Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Multinational, Open Label, Non Comparative, 24-week Study to Evaluate the Blood Glucose Lowering Efficacy and Safety of a Fixed Dose Combination of Glimepiride and Metformin in Patients With Inadequately Controlled Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'GLMET_R_05823'}, 'secondaryIdInfos': [{'id': 'U1111-1120-0058', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': "24-week treatment period: starting dose will be of 2/1000 mg or 4/2000 mg of glimepiride/metformin fixed combination (Amaryl M® ) depending on the previous treatment and dose. The Interventional medicinal product's dose will be increased every 2 weeks up to the maximum tolerated dose of 8/2000 mg of Amaryl M® , and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and \\> 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia.", 'interventionNames': ['Drug: Glimepiride+metformin (Amaryl M®) - HOE4900']}], 'interventions': [{'name': 'Glimepiride+metformin (Amaryl M®) - HOE4900', 'type': 'DRUG', 'description': 'Pharmaceutical form:tablet\n\nRoute of administration: oral', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Investigational Site Number 422-002', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Hazmiyeh', 'country': 'Lebanon', 'facility': 'Investigational Site Number 422-001', 'geoPoint': {'lat': 33.85534, 'lon': 35.53589}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Investigational Site Number 643-03', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Investigational Site Number 643002', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Samara', 'country': 'Russia', 'facility': 'Investigational Site Number 643001', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '58022', 'city': 'Chernivtsi', 'country': 'Ukraine', 'facility': 'Investigational Site Number 804003', 'geoPoint': {'lat': 48.29045, 'lon': 25.93241}}, {'zip': '83003', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Investigational Site Number 804008', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '83059', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Investigational Site Number 804004', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '83099', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Investigational Site Number 804001', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Investigational Site Number 804010', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '36011', 'city': 'Poltava', 'country': 'Ukraine', 'facility': 'Investigational Site Number 804006', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'zip': '21010', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Investigational Site Number 804007', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '21029', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Investigational Site Number 804002', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}