Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-25 @ 6:43 PM
Study NCT ID:
NCT00482950
Status:
UNKNOWN
Last Update Posted:
2009-06-08
First Post:
2007-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-06-04', 'studyFirstSubmitDate': '2007-06-04', 'studyFirstSubmitQcDate': '2007-06-04', 'lastUpdatePostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study is to test the efficacy and safety of PHX1149T in combination with metformin, a glitazone, or metformin and a glitazone in subjects with Type 2 diabetes for 12 weeks. After completing the 12 week double blind part of the study, subjects can enter an open label extension study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Entry Criteria:\n\n* Type 2 diabetes mellitus, diagnosed at least 4 months but not more than 12 years prior to screening.\n* Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 25 to 48 kg/m2, inclusive. For India the BMI is 23 to 48 kg/m2, inclusive.\n* Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of 1500 mg or more (or the highest tolerated dose), or TZD (any labeled dose), or metformin + TZD at doses used in accordance with product labeling for at least 4 weeks (metformin) or 10 weeks (TZD) prior to screening (Visit 1).\n* Fasting plasma glucose of 118 - 220 mg/dL (6.6 - 12.2 mmol/L), inclusive; HbA1c 7.3% - 11.0%, inclusive; and a fasting plasma C peptide greater than 0.26 nmol/L at screening. For Argentina the allowed upper limit of HbA1c is ≤ 10.5%. For Canada the upper limit will be 10.0%\n* No Type 1 diabetes mellitus or marked diabetic long-term complications.'}, 'identificationModule': {'nctId': 'NCT00482950', 'briefTitle': 'A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Phenomix'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PHX1149-Prot202'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PHX1149T', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Trenton', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.21705, 'lon': -74.74294}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'city': 'Westminster', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 42.08089, 'lon': -80.14089}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Multiple Cities', 'country': 'Argentina'}, {'city': 'Mutiple Cities', 'country': 'Canada'}, {'city': 'Mutiple Cities', 'country': 'India'}, {'city': 'Mutiple Cities', 'country': 'Mexico'}], 'overallOfficials': [{'name': 'Hans-Peter Guler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Phenomix Corp.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phenomix', 'class': 'INDUSTRY'}}}}