Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-28 @ 6:22 AM
Study NCT ID:
NCT00947557
Status:
TERMINATED
Last Update Posted:
2011-09-21
First Post:
2009-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin
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': 'C552164', 'term': 'dutogliptin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 677}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'dispFirstSubmitDate': '2011-09-09', 'lastUpdateSubmitDate': '2011-09-09', 'studyFirstSubmitDate': '2009-07-23', 'dispFirstSubmitQcDate': '2011-09-09', 'studyFirstSubmitQcDate': '2009-07-27', 'dispFirstPostDateStruct': {'date': '2011-09-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c (HbA1c)', 'timeFrame': 'HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18), Visit 8 (Week 26).'}], 'secondaryOutcomes': [{'measure': 'Fasting Plasma Glucose (FPG)', 'timeFrame': 'FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18), Visit 8 (Week 26).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type II']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)\n* BMI 20 to 48 kg/m2, inclusive\n* HbA1c 7.0% - 10.0%, inclusive\n* Age 18 to 85 years, inclusive\n\nExclusion Criteria:\n\n* Currently on 3 or more oral antidiabetic drugs or insulin.\n* Type 1 diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT00947557', 'briefTitle': 'Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Placebo-controlled, Multicenter Study To Evaluate The Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Glimepiride With or Without Metformin', 'orgStudyIdInfo': {'id': 'DUT-MD-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dutogliptin', 'description': 'Dutogliptin', 'interventionNames': ['Drug: Dutogliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dutogliptin', 'type': 'DRUG', 'description': 'Dutogliptin oral administration once daily on background of glimepiride with or without metformin', 'armGroupLabels': ['Dutogliptin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, oral administration once daily on background of glimepiride with or without metformin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 064', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 020', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35661', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 025', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 059', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85295', 'city': 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{'lat': 29.21081, 'lon': -81.02283}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 052', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 129', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 062', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33156', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 050', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 021', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 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'lon': -81.05589}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 127', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 018', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33716', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 075', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 026', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30338', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site 045', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 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