Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT00511667
Status:
COMPLETED
Last Update Posted:
2016-08-24
First Post:
2007-08-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C569222', 'term': '3-((6-(ethylsulfonyl)-3-pyridinyl)oxy)-5-(2-hydroxy-1-methylethoxy)-N-(1-methyl-1H-pyrazol-3-yl)benzamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme'}, 'certainAgreement': {'otherDetails': 'The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)', 'eventGroups': [{'id': 'EG000', 'title': 'MK-0941', 'description': 'All participants receiving any dose of MK-0941', 'otherNumAtRisk': 52, 'otherNumAffected': 27, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'All participants receiving any dose of placebo', 'otherNumAtRisk': 18, 'otherNumAffected': 11, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Peripheral coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Any Clinical Adverse Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0941', 'description': 'All participants receiving any dose of MK-0941'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'All participants receiving any dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000'}, {'value': '61.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)', 'unitOfMeasure': 'percentage of of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: MK-0941 10 mg', 'description': 'MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.'}, {'id': 'OG001', 'title': 'Panel B: MK-0941 20 mg', 'description': 'MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.'}, {'id': 'OG002', 'title': 'Panel C: MK-0941 40 mg Day 7', 'description': 'MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.'}, {'id': 'OG003', 'title': 'Panel D: MK-0941 40 mg Day 13', 'description': 'MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.'}, {'id': 'OG004', 'title': 'Panel E: MK-0941 60 mg', 'description': 'MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '2343.29', 'spread': '253.73', 'groupId': 'OG000'}, {'value': '3789.25', 'spread': '1002.05', 'groupId': 'OG001'}, {'value': '8387.74', 'spread': '2102.17', 'groupId': 'OG002'}, {'value': '7673.77', 'spread': '3616.45', 'groupId': 'OG003'}, {'value': '8692.07', 'spread': '2681.37', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)', 'unitOfMeasure': 'nM-hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: MK-0941 10 mg', 'description': 'MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.'}, {'id': 'OG001', 'title': 'Panel B: MK-0941 20 mg', 'description': 'MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.'}, {'id': 'OG002', 'title': 'Panel C: MK-0941 40 mg Day 7', 'description': 'MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.'}, {'id': 'OG003', 'title': 'Panel D: MK-0941 40 mg Day 13', 'description': 'MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.'}, {'id': 'OG004', 'title': 'Panel E: MK-0941 60 mg', 'description': 'MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '228.35', 'spread': '88.54', 'groupId': 'OG000'}, {'value': '364.96', 'spread': '151.25', 'groupId': 'OG001'}, {'value': '841.57', 'spread': '348.34', 'groupId': 'OG002'}, {'value': '648.49', 'spread': '159.73', 'groupId': 'OG003'}, {'value': '1145.81', 'spread': '330.56', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: MK-0941 10 mg', 'description': 'MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.'}, {'id': 'OG001', 'title': 'Panel B: MK-0941 20 mg', 'description': 'MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.'}, {'id': 'OG002', 'title': 'Panel C: MK-0941 40 mg Day 7', 'description': 'MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.'}, {'id': 'OG003', 'title': 'Panel D: MK-0941 40 mg Day 13', 'description': 'MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.'}, {'id': 'OG004', 'title': 'Panel E: MK-0941 60 mg', 'description': 'MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '6.43', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '1.0', 'spread': '9.35', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1.0', 'spread': '34.95', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '1.0', 'spread': '24.27', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '2.0', 'spread': '82.68', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: MK-0941 10 mg Before Each Meal', 'description': 'MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.'}, {'id': 'OG001', 'title': 'Panel B: MK-0941 20 mg', 'description': 'MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.'}, {'id': 'OG002', 'title': 'Panel C: MK-0941 40 mg Day 7', 'description': 'MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.'}, {'id': 'OG003', 'title': 'Panel D: MK-0941 40 mg Day 13', 'description': 'MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.'}, {'id': 'OG004', 'title': 'Panel E: MK-0941 60 mg', 'description': 'MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '6.3', 'groupId': 'OG002'}, {'value': '10.1', 'spread': '3.5', 'groupId': 'OG003'}, {'value': '11.4', 'spread': '2.1', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: MK-0941 10 mg', 'description': 'MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.'}, {'id': 'OG001', 'title': 'Panel B: MK-0941 20 mg', 'description': 'MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.'}, {'id': 'OG002', 'title': 'Panel C: MK-0941 40 mg Day 7', 'description': 'MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.'}, {'id': 'OG003', 'title': 'Panel D: MK-0941 40 mg Day 13', 'description': 'MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.'}, {'id': 'OG004', 'title': 'Panel E: MK-0941 60 mg', 'description': 'MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.75', 'spread': '6.43', 'groupId': 'OG000'}, {'value': '42.99', 'spread': '9.35', 'groupId': 'OG001'}, {'value': '95.07', 'spread': '34.95', 'groupId': 'OG002'}, {'value': '76.89', 'spread': '24.27', 'groupId': 'OG003'}, {'value': '149.30', 'spread': '82.68', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participants Discontinued Because of Any Clinical Adverse Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0941', 'description': 'All participants receiving any dose of MK-0941'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'All participants receiving any dose of placebo'}], 'classes': [{'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'All other adverse experiences', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK-0941', 'description': 'All participants receiving any dose of MK-0941'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'All participants receiving any dose of placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Site terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MK-0941', 'description': 'All participants receiving any dose of MK-0941'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'All participants receiving any dose of placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '29 to 70 years', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2007-08-02', 'resultsFirstSubmitDate': '2012-04-04', 'studyFirstSubmitQcDate': '2007-08-03', 'lastUpdatePostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-22', 'studyFirstPostDateStruct': {'date': '2007-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants With Any Clinical Adverse Experience', 'timeFrame': 'Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)'}, {'measure': 'Participants Discontinued Because of Any Clinical Adverse Experience', 'timeFrame': 'Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941', 'timeFrame': 'Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)'}, {'measure': 'Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941', 'timeFrame': 'Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)'}, {'measure': 'Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941', 'timeFrame': 'Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)'}, {'measure': 'Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941', 'timeFrame': 'Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)'}, {'measure': 'Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941', 'timeFrame': 'Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nonsmoking Male or Female (of non-child bearing potential)\n* Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents\n* Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more\n\nExclusion Criteria:\n\n* Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist\n* Subject is on 3 or more oral anti-diabetes medications\n* Subject has a history of type 1 diabetes\n* Subject has a diagnosis of glaucoma or is blind\n* Subject has had trauma to one or both eyes'}, 'identificationModule': {'nctId': 'NCT00511667', 'briefTitle': 'A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration of MK0941 Before Each Meal (q.a.c.) in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '0941-005'}, 'secondaryIdInfos': [{'id': '2007_595'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK0941', 'interventionNames': ['Drug: MK0941']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo']}], 'interventions': [{'name': 'MK0941', 'type': 'DRUG', 'description': 'MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day', 'armGroupLabels': ['MK0941']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day', 'armGroupLabels': ['Placebo']}]}, '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'}}}}