Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-27 @ 3:47 AM
Study NCT ID:
NCT01240759
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2010-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, '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': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'dispFirstSubmitDate': '2018-04-26', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-10', 'studyFirstSubmitDate': '2010-11-11', 'dispFirstSubmitQcDate': '2018-04-26', 'studyFirstSubmitQcDate': '2010-11-12', 'dispFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Hemoglobin A1c'}], 'secondaryOutcomes': [{'measure': 'Serial pharmacokinetic (PK) assessments', 'timeFrame': '5 days', 'description': 'Serial pharmacokinetic sampling at Visit 6 prior to dosing, at Visit 7 prior to dosing and at 0.5, 1, 2, 3, 4, 6, 8 and 24 hours after dosing, at Visit 8, at Visit 9, and Early Termination Visit'}, {'measure': 'Sparse pharmacokinetic assessments', 'timeFrame': '5 days', 'description': 'Sparse pharmacokinetic sampling at Visit 6 and Visit 7 prior to dosing, at Visit 6 or Visit 7 one additional post-dose sample, at Visit 8, at Visit 9, and Early Termination Visit'}, {'measure': 'Percent of subjects with Hemoglobin A1c < 7.0% at Week 12', 'timeFrame': '12 weeks', 'description': 'Hemoglobin A1c'}, {'measure': 'Change from Baseline at Week 12 in: Fasting plasma glucose, 1,5-Anhydroglucitol, Fructosamine, Glycoalbumin, C-peptide, Beta-cell function and insulin resistance indices using Homeostatic Model Assessment, and Postprandial glucose test', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Fasting plasma glucose, 1,5-Anhydroglucitol, Fructosamine, Glycoalbumin, C-peptide, Beta-cell function and insulin resistance indices using Homeostatic Model Assessment, and Postprandial glucose test'}, {'measure': 'Safety assessments', 'timeFrame': '5-6 months', 'description': 'Safety will be assessed by monitoring of treatment-emergent adverse events, serious adverse events, treatment-emergent adverse events leading to study drug discontinuation, clinical laboratory evaluations, vital signs, 12-lead electrocardiograms (ECGs), adrenal axis hormones, and treatment-emergent adverse events of hypoglycemia, hyperglycemia, confirmed hypoglycemia or hyperglycemia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Metformin'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered with metformin in subjects with type 2 diabetes mellitus.', 'detailedDescription': 'Based on the unmet clinical need for more safe and effective type 2 diabetes mellitus therapies, together with the nonclinical efficacy and safety profile of S-707106, Shionogi USA, Inc. is initiating studies to further assess the efficacy, clinical pharmacology and safety profile of S-707106 in preparation for full clinical development as a novel treatment for type 2 diabetes mellitus. It is anticipated that S-707106 will provide clinicians and patients with a new therapeutic option to treat type 2 diabetes mellitus with potential advantages over existing therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Subjects with type 2 diabetes mellitus receiving a stable dose of metformin for the past 3 months (with no other medication for glycemic control) and who are clinically stable as determined by medical history\n* Body mass index (BMI) ≥25.0 and \\<45.0 (kg/m2) using http://www.bmicalculator.org/ as the BMI calculator\n* No clinically significant abnormal laboratory tests as determined by the investigator except Hemoglobin A1c level ≥7.5% and ≤11.0% and C peptide level \\>1.0 ng/mL\n\nMain Exclusion Criteria:\n\n* Type 1 diabetes mellitus or gestational diabetes mellitus within last 6 months\n* Use of any medication for glycemic control other than metformin during the past 3 months or thiazolidinediones within the past year\n* Congestive heart failure as defined by New York Heart Association class III or IV\n* Fasting glucose \\>270 mg/dL\n* Creatinine clearance is \\<60 mL/minute\n* History of myocardial infarction within the past 3 months, history of clinically significant cardiac arrhythmia, clinically significant hypotension or hypertension, or clinically significant abnormal electrocardiogram as determined by the investigator'}, 'identificationModule': {'nctId': 'NCT01240759', 'briefTitle': 'Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shionogi Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy', 'orgStudyIdInfo': {'id': '1010N0921'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-707106 Dose A', 'description': 'One S-707106 A tablet + 3 Placebo A tablets', 'interventionNames': ['Drug: S-707106 Dose A', 'Drug: Placebo A tablet', 'Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'S-707106 Dose B', 'description': 'One S-707106 B tablet + 3 Placebo A tablets', 'interventionNames': ['Drug: S-707106 Dose B', 'Drug: Placebo A tablet', 'Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'S-707106 Dose C', 'description': 'S-707106 Dose C = Four S-707106 B tablets', 'interventionNames': ['Drug: S-707106 Dose C', 'Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'The standard of care dose of metformin for the individual patient + 3 Placebo A tablets', 'interventionNames': ['Drug: Placebo A tablet', 'Drug: Metformin']}], 'interventions': [{'name': 'S-707106 Dose A', 'type': 'DRUG', 'description': 'One S-707106 A tablet', 'armGroupLabels': ['S-707106 Dose A']}, {'name': 'S-707106 Dose B', 'type': 'DRUG', 'description': 'One S-707106 B tablet', 'armGroupLabels': ['S-707106 Dose B']}, {'name': 'S-707106 Dose C', 'type': 'DRUG', 'description': 'Four S-707106 4 X B tablets', 'armGroupLabels': ['S-707106 Dose C']}, {'name': 'Placebo A tablet', 'type': 'DRUG', 'description': 'Up to 4 Placebo A tablets', 'armGroupLabels': ['Metformin', 'S-707106 Dose A', 'S-707106 Dose B']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'The standard of care dose of metformin for each patient', 'armGroupLabels': ['Metformin', 'S-707106 Dose A', 'S-707106 Dose B', 'S-707106 Dose C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Juno Research, LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Shionogi Clinical Trials Administrator Clinical Support Help Line', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shionogi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shionogi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}