Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 7:13 PM
Study NCT ID:
NCT00957060
Status:
COMPLETED
Last Update Posted:
2010-11-30
First Post:
2009-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients
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': 'C057619', 'term': 'glimepiride'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-26', 'studyFirstSubmitDate': '2009-08-11', 'studyFirstSubmitQcDate': '2009-08-11', 'lastUpdatePostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'at baseline, week 12 and week 24'}, {'measure': 'Fasting and postprandial glucose', 'timeFrame': 'at baseline, week 2, 4, 12 and 24'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo determine the superiority of glimepiride over sitagliptin in the reduction of HbA1c after 6 months of treatment in patients with monotherapy until the end of the trial.\n\nSecondary Objective:\n\nTo evaluate the effect of glimepiride compared to sitagliptin in:\n\nGlucose in fasting conditions; Postprandial glucose; Percentage of patients with HbA1c \\< 7% and \\< 6.5%; Symptomatic Hypoglycemia; Body weight; Percentage of withdrawal and percentage of patients with rescue therapy; Safety (adverse events and serious adverse events, hypoglycemia, vital signs and laboratory results).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Subject naïve to treatment\n* HbA1c \\> 8.5 up to 11 %\n* Lipid lowering therapy, antihypertensive, hormonal substitutes, thyroid hormone substitutes, and contraceptives are allowed as long as they are kept at a stable dosing\n\nExclusion criteria:\n\n* Treatment with any oral antidiabetics or insulin\n* Known type 1 Diabetes Mellitus\n* Pregnant or breast feeding women\n* Ketoacidosis history\n* History of sensitivity to any of the active substances\n* Renal dysfunction : serum creatinine \\> or = 1.5 mg/dL in male subjects \\> or = 1.4 mg/dL in female subjects\n* Liver impairment (ALT, AST \\> 3-fold the upper limit of normal range)\n* Systemic corticosteroid treatment 3 months prior to study or during the study\n* Drug or alcohol abuse history\n* Patients with history of acute coronary syndrome, cerebrovascular events/transient ischaemic attack in the last three months\n* Presence of any condition (medical, psychological, social or geographic) current or previously seen that according to Investigators judgment jeopardizes the safety or restricts the participation of the patient during the study\n* Neoplasias\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00957060', 'acronym': 'SUMER', 'briefTitle': 'Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Multicenter, Open, Randomized, 24 Weeks Study to Evaluate the Superiority of Glimepiride Over Sitagliptin for the Treatment of naïve Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'GLIME_L_04140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'glimepiride', 'description': 'The initial dose is 2 mg once a day. At week 2, the dose can be increased to 4 mg once a day according to the titration. At week 4 and 12, the dose can be increased from 2 mg to 4 mg or from 4 mg to 6 mg according to the titration.', 'interventionNames': ['Drug: GLIMEPIRIDE (HOE490)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sitagliptin', 'description': '100 mg once a day. The dose will not be titrated.', 'interventionNames': ['Drug: SITAGLIPTIN']}], 'interventions': [{'name': 'GLIMEPIRIDE (HOE490)', 'type': 'DRUG', 'description': 'Pharmaceutical form: 2 mg and 4 mg tablets Route of administration: oral', 'armGroupLabels': ['glimepiride']}, {'name': 'SITAGLIPTIN', 'type': 'DRUG', 'description': 'Pharmaceutical form: 100 mg tablets Route of administration: oral', 'armGroupLabels': ['sitagliptin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'city': 'Col. Coyoacan', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Administrative Office'}], 'overallOfficials': [{'name': 'Judith Diaz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Trial Transparency Team', 'oldOrganization': 'sanofi-aventis'}}}}