Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT01951235
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2013-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes
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': 'C575881', 'term': 'imeglimin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'dispFirstSubmitDate': '2015-07-02', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-24', 'studyFirstSubmitDate': '2013-09-19', 'dispFirstSubmitQcDate': '2015-07-24', 'studyFirstSubmitQcDate': '2013-09-23', 'dispFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'Baseline and week 24'}], 'secondaryOutcomes': [{'measure': 'Safety will be assessed by the incidence of adverse events (AEs), physical examination, relevant changes on laboratory tests, vital signs, and 12-lead electrocardiograms (ECG)', 'timeFrame': 'Baseline to week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus placebo. The study will be performed in subjects with type 2 diabetes either naive of treatment or previously treated with an oral monotherapy excluding thiazolidinedione.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject has given written informed consent\n2. Male and female type 2 diabetic subjects, either naïve of antidiabetic agents or treated with an oral anti-diabetic monotherapy.\n3. Body mass index (BMI) : ≥ 24 to ≤ 40 kg/m²\n4. HbA1c criteria: ≥ 7% and ≤ 9.5%\n5. Creatinine clearance ≥ 50 mL/\\[min\\*1.73 m2\\] at Screening Visit\n6. Effective contraception for women of child bearing potential\n\nExclusion Criteria:\n\n1. Any disease which in the investigator's opinion would exclude the subject from the study\n2. Acute cardiovascular event within 3 months before randomization\n3. Uncontrolled high blood pressure\n4. Impairment of hepatic function\n5. History of drug-induced Torsades de Pointes or a marked baseline prolongation of the QTc interval\n6. Pregnancy or lactation\n7. Use of any non-permitted medication\n8. Positive screen for viral hepatitis"}, 'identificationModule': {'nctId': 'NCT01951235', 'briefTitle': 'A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Poxel SA'}, 'officialTitle': 'A Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes Mellitus.', 'orgStudyIdInfo': {'id': 'PXL008-008'}, 'secondaryIdInfos': [{'id': '2012-004045-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imeglimin (Dose 1)', 'interventionNames': ['Drug: Imeglimin']}, {'type': 'EXPERIMENTAL', 'label': 'Imeglimin (Dose 2)', 'interventionNames': ['Drug: Imeglimin']}, {'type': 'EXPERIMENTAL', 'label': 'Imeglimin (Dose 3)', 'interventionNames': ['Drug: Imeglimin']}, {'type': 'EXPERIMENTAL', 'label': 'Imeglimin (Dose 4)', 'interventionNames': ['Drug: Imeglimin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Imeglimin', 'type': 'DRUG', 'armGroupLabels': ['Imeglimin (Dose 1)', 'Imeglimin (Dose 2)', 'Imeglimin (Dose 3)', 'Imeglimin (Dose 4)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riga', 'country': 'Latvia', 'facility': 'Pauls Stradins Clinical University Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}], 'overallOfficials': [{'name': 'Valdis Pirags, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'P. Stradins Clinical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poxel SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}