Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-03-11 @ 12:54 PM
Study NCT ID:
NCT01984606
Status:
WITHDRAWN
Last Update Posted:
2014-10-27
First Post:
2013-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, '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': 'C570240', 'term': 'empagliflozin'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-24', 'studyFirstSubmitDate': '2013-11-08', 'studyFirstSubmitQcDate': '2013-11-08', 'lastUpdatePostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change from baseline in HbA1c after 52 weeks of treatment.', 'timeFrame': 'Baseline and week 52'}], 'secondaryOutcomes': [{'measure': 'The change in bodyweight (kg) from baseline after 52 weeks of treatment', 'timeFrame': 'Baseline and week 52'}, {'measure': 'The change in Systolic Blood Pressure (SBP) from baseline after 52 weeks of treatment', 'timeFrame': 'Baseline and week 52'}, {'measure': 'The coefficient of durability of HbA1c response between 24 weeks and 52 weeks of treatment', 'timeFrame': 'Week 24 and week 52'}, {'measure': 'The change in Diastolic Blood Pressure (DBP) from baseline after 52 weeks of treatment', 'timeFrame': 'Baseline and week 52'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess safety and efficacy of empagliflozin compared to sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on treatment with metformin and have insufficient glycaemic control. The study will assess non-inferiority of empagliflozin to sitagliptin with regards to HbA1c.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nInclusion criteria:\n\n* Diagnosis of type 2 diabetes mellitus.\n* Male and female patients on diet and exercise regimen who are:\n* Treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation.\n\nor\n\n* Pre-treated with immediate release metformin unchanged for 10 weeks prior to randomisation. Minimum dose for metformin: \\>=1500 mg/day or maximum tolerated dose or maximum dose according to local label.\n* HbA1c of \\>= 7.5 % and \\<= 10.5 % at Visit 1 and 3.\n* Age \\>= 18 yrs.\n\nExclusion criteria:\n\n* Uncontrolled hyperglycaemia with a glucose level \\>270 mg/dL (\\>15 mmol/L) after an overnight fast during dose stabilisation (if applicable) and/or placebo run-in.\n* Any other antidiabetic drug within 12 weeks prior to randomisation (applicable to treatment-naïve patients).\n* Any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin).\n* Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent.\n* Indication of liver disease.\n* Moderate to severe renal impairment.\n* Bariatric surgery within the past two years.\n* Treatment with anti-obesity drugs 3 months prior to informed consent.\n* Current treatment with systemic steroids at time of informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT01984606', 'briefTitle': 'Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase IIIb Randomised, Double-blind, Active-controlled, Parallel Group, Efficacy and Safety Study of Once Daily Oral Administration of Empagliflozin 25 mg Compared to Sitagliptin 100 mg During 52 Weeks in Type 2 Diabetes Mellitus Patients Who Are Treatment-naïve or on Treatment With Metformin With Insufficient Glycaemic Control', 'orgStudyIdInfo': {'id': '1245.22'}, 'secondaryIdInfos': [{'id': '2013-000060-29', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empagliflozin', 'description': 'Empagliflozin once daily', 'interventionNames': ['Drug: Empagliflozin', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin', 'description': 'Sitagliptin once daily', 'interventionNames': ['Drug: Sitagliptin', 'Drug: Placebo']}], 'interventions': [{'name': 'Empagliflozin', 'type': 'DRUG', 'description': 'Empagliflozin once daily', 'armGroupLabels': ['Empagliflozin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matching empagliflozin', 'armGroupLabels': ['Empagliflozin']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'description': 'Sitagliptin once daily', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matching sitagliptin', 'armGroupLabels': ['Sitagliptin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}