Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT00958269
Status:
TERMINATED
Last Update Posted:
2010-02-03
First Post:
2009-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552164', 'term': 'dutogliptin'}, {'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', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'whyStopped': 'Technical/operational issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-01', 'studyFirstSubmitDate': '2009-08-12', 'studyFirstSubmitQcDate': '2009-08-12', 'lastUpdatePostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of dutogliptin as assessed by analysis of AEs/SAEs, laboratory data, vital signs, and ECGs', 'timeFrame': 'Day 1 through day 182 (end of the 26-week, double-blind, placebo-controlled period) and through Day 364 (end of the 26-week, sitagliptin-controlled period of the study)'}], 'secondaryOutcomes': [{'measure': 'Change of HbA1c', 'timeFrame': 'Day 1 to Day 182'}, {'measure': 'Change of fasting plasma glucose', 'timeFrame': 'Day 1 to Day 182'}, {'measure': 'Plasma dutogliptin levels', 'timeFrame': 'Days 1, 198 and 182'}, {'measure': 'Per cent ex vivo DPP4 inhibition after drug dosing', 'timeFrame': 'Days 1, 98, and 182'}]}, 'conditionsModule': {'keywords': ['diabetes', 'DPP4 inhibitor', 'dutogliptin', 'PHX1149'], 'conditions': ['Type 2 Diabetes Mellitus', 'Renal Impairment']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of dutogliptin in Type 2 diabetic subjects with moderate or severe renal impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Renal impairment (moderate and severe)\n* Currently on stable doses of background medication of SU, TZD, acarbose, meglitinide, insulin or any combination thereof, or on no antidiabetic drugs at all\n* HbA1c 7.0% - 10.5%, inclusive\n* Male or female subjects between the ages of 18 and 85 years, inclusive.\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus or history of diabetic ketoacidosis, mature onset diabetes of the young (MODY)\n* Kidney transplant'}, 'identificationModule': {'nctId': 'NCT00958269', 'briefTitle': 'Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Phenomix'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo- and Sitagliptin-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment Including Subjects on Hemodialysis', 'orgStudyIdInfo': {'id': 'PHX1149-PROT306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dutogliptin (double-blind, placebo-controlled period)', 'description': 'weeks 1-26', 'interventionNames': ['Drug: dutogliptin']}, {'type': 'EXPERIMENTAL', 'label': 'dutogliptin (single-blind, active-controlled period)', 'description': 'weeks 27-52', 'interventionNames': ['Drug: dutogliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo (double-blind, placebo-controlled period)', 'description': 'weeks 1-26', 'interventionNames': ['Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo (single-blind, active-controlled period)', 'description': 'weeks 27-52', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sitagliptin (single-blind, active-controlled period)', 'description': 'weeks 27-52', 'interventionNames': ['Drug: sitagliptin']}], 'interventions': [{'name': 'dutogliptin', 'type': 'DRUG', 'description': '100 mg QD', 'armGroupLabels': ['dutogliptin (double-blind, placebo-controlled period)', 'dutogliptin (single-blind, active-controlled period)']}, {'name': 'dutogliptin', 'type': 'DRUG', 'description': '200 mg QD', 'armGroupLabels': ['dutogliptin (double-blind, placebo-controlled period)', 'dutogliptin (single-blind, active-controlled period)']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo (double-blind, placebo-controlled period)', 'placebo (single-blind, active-controlled period)']}, {'name': 'sitagliptin', 'type': 'DRUG', 'description': '25 mg QD', 'armGroupLabels': ['sitagliptin (single-blind, active-controlled period)']}, {'name': 'sitagliptin', 'type': 'DRUG', 'description': '50 mg QD', 'armGroupLabels': ['sitagliptin (single-blind, active-controlled period)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phenomix Investigational Site 115', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Phenomix Investigational Site 121', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Lynwood', 'state': 'California', 'country': 'United States', 'facility': 'Phenomix Investigational Site 110', 'geoPoint': {'lat': 33.93029, 'lon': -118.21146}}, {'city': 'Lynwood', 'state': 'California', 'country': 'United States', 'facility': 'Phenomix Investigational Site 118', 'geoPoint': {'lat': 33.93029, 'lon': -118.21146}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Phenomix Investigational Site 119', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Phenomix Investigational Site 109', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Phenomix Investigational Site 122', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'city': 'Lauderdale Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Phenomix Investigational Site 112', 'geoPoint': {'lat': 26.16647, 'lon': -80.20838}}, {'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Phenomix Investigational Site 104', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Phenomix Investigational Site 116', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Phenomix Investigational Site 101', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Phenomix Investigational Site 117', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Phenomix Investigational Site 102', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Phenomix Investigational Site 100', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Phenomix Investigational Site 125', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'city': 'Springfield Gardens', 'state': 'New York', 'country': 'United States', 'facility': 'Phenomix Investigational Site 114', 'geoPoint': {'lat': 40.66312, 'lon': -73.76221}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Phenomix Investigational Site 120', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Phenomix Investigational Site 107', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Phenomix Investigational Site 111', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Phenomix Investigational Site 103', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Phenomix Investigational Site 106', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Phenomix Investigational Site 108', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'Phenomix Investigational Site 113', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}, {'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 208', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 203', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 204', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 209', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 211', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 205', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'city': 'Perm', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 207', 'geoPoint': {'lat': 58.01046, 'lon': 56.25017}}, {'city': 'Petrozavodsk', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 206', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 200', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 201', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 210', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 212', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Phenomix Investigational Site 213', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Chernivtsi', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 304', 'geoPoint': {'lat': 48.29045, 'lon': 25.93241}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 300', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 301', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 306', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 302', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'city': 'Vinnytsa', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 303'}, {'city': 'Zaporizhzhya', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 307', 'geoPoint': {'lat': 47.85167, 'lon': 35.11714}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phenomix', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Hans-Peter Guler, MD', 'oldOrganization': 'Phenomix Corporation'}}}}