Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT03125694
Status:
COMPLETED
Last Update Posted:
2017-04-24
First Post:
2017-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], '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'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-19', 'studyFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2017-04-19', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean glycated hemoglobin (A1C) levels by sitagliptin vs. pioglitazone', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uncontrolled Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study has been designed to investigate the comparative effects of sitagliptin vs. pioglitazone as add-on treatments in patients with type 2 diabetes who were uncontrolled on the full-dose of metformin and sulfonylurea'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of type 2 diabetes according to the American Diabetes Association\n* Baseline level of 7% ≤ A1C \\< 11% despite a minimum 6 months period of active treatment with metformin 2000 mg/day plus gliclazide 240 mg/day (uncontrolled type 2 diabetes)\n\nExclusion Criteria:\n\n* Acute or chronic diseases of heart, lung, kidney,\n* Active or past infectious conditions\n* Malignancy'}, 'identificationModule': {'nctId': 'NCT03125694', 'briefTitle': 'Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Efficacy, Durability, Safety, and Tolerability of Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea: a 52-week, Randomized, Open-label, Parallel-group, Phase 3 Clinical Trial', 'orgStudyIdInfo': {'id': '9311160040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin', 'interventionNames': ['Drug: Sitagliptin 100mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pioglitazone', 'interventionNames': ['Drug: Pioglitazone 30 mg']}], 'interventions': [{'name': 'Sitagliptin 100mg', 'type': 'DRUG', 'description': 'Sitagliptin arm took sitagliptin 100 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Pioglitazone 30 mg', 'type': 'DRUG', 'description': 'Pioglitazone arm took pioglitazone 30 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks', 'armGroupLabels': ['Pioglitazone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Tehran University of Medical Sciences', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor of Medicine', 'investigatorFullName': 'Alireza Esteghamati', 'investigatorAffiliation': 'Tehran University of Medical Sciences'}}}}