Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT02053103
Status:
TERMINATED
Last Update Posted:
2016-05-02
First Post:
2014-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'On 25April2014, study was terminated before any dosing due to an AE of safety concern that occurred in protocol B1731003 with the same drug.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'dispFirstSubmitDate': '2016-03-29', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2014-01-30', 'dispFirstSubmitQcDate': '2016-03-29', 'studyFirstSubmitQcDate': '2014-01-30', 'dispFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo', 'timeFrame': 'Baseline, Day 42'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo', 'timeFrame': 'Weeks 0 and 4'}, {'measure': 'Change from baseline in fasting plasma glucose', 'timeFrame': 'Weeks 0, 2, 4 and 6'}, {'measure': 'Change from baseline in Glycosylated Hemoglobin (HbA1c)', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Change from baseline in fasting total cholesterol', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Change from baseline in glucose AUC(0-5) during mixed meal tolerance test (MMTT)', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Change from baseline in insulin AUC(0-5) during mixed meal tolerance test (MMTT)', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Change from baseline in ratio of AUC (0-5) C-peptide to AUC(0-5) glucose during the MMTT', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Change from baseline in ratio of AUC(0-5) insulin to AUC(0-5) glucose during the MMTT', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR)', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Change from baseline in homeostatic model assessment for β-cell function (HOMA B)', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Plasma concentrations for PF-05175157', 'timeFrame': 'Weeks 2, 4 and 6'}, {'measure': 'Percent change from baseline in body weight', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Change from baseline in low density lipoprotein cholesterol (LDL-C)', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Change from baseline in high density lipoprotein cholesterol (HDL-C)', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Change from baseline in triglycerides', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Change from baseline in non-HDL cholesterol', 'timeFrame': 'Weeks 0, 4 and 6'}, {'measure': 'Change from baseline in very low density lipoprotein (VLDL)', 'timeFrame': 'Weeks 0, 4 and 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1731002&StudyName=A%206-Week%20Study%20To%20Determine%20The%20Safety%20And%20Effect%20Of%20An%20Investigational%20Drug%20On%20Adults%20With%20Type%202%20Diabetes%20Mellitus%20Taking%20Metformi', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks in adult subjects with Type 2 Diabetes Mellitus (T2DM) on metformin background therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months\n* Hemoglobin A1c of 7-10% at screening.\n* Body Mass Index of at least 25 kg/m2.\n\nExclusion Criteria:\n\n* Compliant with study drug administration during the run-in period and throughout the trial.\n* Patients with fasting triglycerides greater than 500 mg/dL at screening.\n* History of certain diabetic complications or cardiac problems.'}, 'identificationModule': {'nctId': 'NCT02053103', 'briefTitle': 'A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A 6-Week Phase 2a Randomized, Double-Blind, Placebo-Controlled Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 In Adult Subjects With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin', 'orgStudyIdInfo': {'id': 'B1731002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-05175157', 'interventionNames': ['Drug: PF-05175157']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-05175157', 'type': 'DRUG', 'description': 'Tablet, 200 mg, twice daily, 6 weeks', 'armGroupLabels': ['PF-05175157']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet, 0 mg, twice daily, 6 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}