Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT00543959
Status:
TERMINATED
Last Update Posted:
2015-06-23
First Post:
2007-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 346}}, 'statusModule': {'whyStopped': 'This study is being discontinued based on data suggesting that none of the doses tested demonstrated both glycemic \\& body fluid benefits vs. the comparitor', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2007-10-05', 'studyFirstSubmitQcDate': '2007-10-11', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body fluid gain from baseline after 12 weeks', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Fasting plasma glucose after 12 weeks', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels\n* Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened\n\nExclusion Criteria:\n\n* Patients taking any medicines that affect body fluid level such as a diuretic or water pill\n* Patients taking niacin or other certain medications\n* Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders\n* Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study'}, 'identificationModule': {'nctId': 'NCT00543959', 'briefTitle': 'Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Efficacy and Tolerability Study of MK0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control', 'orgStudyIdInfo': {'id': '0533-005'}, 'secondaryIdInfos': [{'id': 'MK0533-005'}, {'id': '2007_544'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part1 - Arm 1', 'description': 'Part1: Arm 1: drug', 'interventionNames': ['Drug: MK0533']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part1 - Arm 2', 'description': 'Part1 - Arm 2: Pbo comparator', 'interventionNames': ['Drug: Comparator: Placebo (unspecified)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2 - Arm 1', 'description': 'Part 2 - Arm 1: Pbo', 'interventionNames': ['Drug: Comparator: Placebo (unspecified)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Arm 2', 'description': 'Part 2- Arm 2: drug 5mg', 'interventionNames': ['Drug: MK0533']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Arm 3', 'description': 'Part 2 - Arm 3: drug 15mg', 'interventionNames': ['Drug: MK0533']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Arm 4', 'description': 'Part 2 - Arm 4: drug 30mg', 'interventionNames': ['Drug: MK0533']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2 - Arm 5', 'description': 'Part 2 - Arm 5: active comparator', 'interventionNames': ['Drug: Comparator: pioglitazone']}], 'interventions': [{'name': 'MK0533', 'type': 'DRUG', 'description': 'Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.', 'armGroupLabels': ['Part 2 - Arm 2', 'Part 2 - Arm 3', 'Part 2 - Arm 4', 'Part1 - Arm 1']}, {'name': 'Comparator: Placebo (unspecified)', 'type': 'DRUG', 'description': 'MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.', 'armGroupLabels': ['Part 2 - Arm 1', 'Part1 - Arm 2']}, {'name': 'Comparator: pioglitazone', 'type': 'DRUG', 'description': 'pioglitazone 45mg. Study period is a total of 24 wks.', 'armGroupLabels': ['Part 2 - Arm 5']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}