Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-08 @ 6:16 AM
Study NCT ID:
NCT00924534
Status:
COMPLETED
Last Update Posted:
2012-01-04
First Post:
2009-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety PK/PD Study of SLV337 in Patients 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-30', 'studyFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2009-06-18', 'lastUpdatePostDateStruct': {'date': '2012-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in alanine amino transferase level to Day 35', 'timeFrame': '35 days'}, {'measure': 'Change from baseline in Creatinine level to Day 35', 'timeFrame': '35 days'}, {'measure': 'Change from baseline in the count of Red blood cells to Day 35', 'timeFrame': '35 days'}, {'measure': 'Change from baseline in White blood cells count to Day 35', 'timeFrame': '35 days'}, {'measure': 'Change from baseline in Creatinine kinase level to Day 35', 'timeFrame': '35 days'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Fasting plasma glucose level to Day 28', 'timeFrame': '28 days'}, {'measure': 'Change from baseline in Adiponectin level to Day 28', 'timeFrame': '28 days'}, {'measure': 'Change from baseline in Triglycerides level to Day 28', 'timeFrame': '28 days'}, {'measure': 'Change from baseline in High density lipoprotein cholesterol level to Day 28', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 2 diabetes', 'interventional', 'placebo', 'controlled', 'PK', 'PD', 'safety'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Type 2 diabetes ,stable dose of Metformin,HbA1c \\>= 7%, but \\< 9% Exclusion Criteria Type 1 diabetes mellitus, Body Mass Index (BMI) \\>40.0 kg/m2, evidence of unstable cardiovascular diseases, NYHA class I to IV, ALT \\> 1.5 times UNL, creatinine clearance \\<60 mL/min'}, 'identificationModule': {'nctId': 'NCT00924534', 'briefTitle': 'A Safety PK/PD Study of SLV337 in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV337 in Patients With Type 2 Diabetes on Metformin Monotherapy', 'orgStudyIdInfo': {'id': 'S337.2.001'}, 'secondaryIdInfos': [{'id': '2009-011589-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: SLV337']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: SLV337']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Drug: SLV337']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['1']}, {'name': 'SLV337', 'type': 'DRUG', 'description': 'SLV337 400 mg/day', 'armGroupLabels': ['2']}, {'name': 'SLV337', 'type': 'DRUG', 'description': 'SLV337 800 mg/day', 'armGroupLabels': ['3']}, {'name': 'SLV337', 'type': 'DRUG', 'description': 'SLV337 1400 mg/day', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6400', 'city': 'Dimitrovgrad', 'country': 'Bulgaria', 'facility': 'Site Reference ID/Investigator# 54183', 'geoPoint': {'lat': 42.05, 'lon': 25.6}}, {'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Site Reference ID/Investigator# 54182', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Site Reference ID/Investigator# 44722', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Site Reference ID/Investigator# 44723', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '59-301', 'city': 'Lubin', 'country': 'Poland', 'facility': 'Site Reference ID/Investigator# 44725', 'geoPoint': {'lat': 51.40089, 'lon': 16.20149}}, {'zip': '24-100', 'city': 'Puławy', 'country': 'Poland', 'facility': 'Site Reference ID/Investigator# 44724', 'geoPoint': {'lat': 51.41655, 'lon': 21.96939}}, {'zip': '05-250', 'city': 'Radzymin', 'country': 'Poland', 'facility': 'Site Reference ID/Investigator# 54185', 'geoPoint': {'lat': 52.41592, 'lon': 21.18415}}, {'city': 'Ruda Śląska', 'country': 'Poland', 'facility': 'Site Reference ID/Investigator# 44727', 'geoPoint': {'lat': 50.2584, 'lon': 18.85632}}, {'zip': '50-349', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Site Reference ID/Investigator# 54184', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '7130', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Site Reference ID/Investigator# 44728', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7937', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Site Reference ID/Investigator# 44730', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '2198', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Site Reference ID/Investigator# 44729', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Francis Roy, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Products'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Products', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}