Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT00567112
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2007-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)
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': 'D019518', 'term': 'Postprandial Period'}], 'ancestors': [{'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug administration through to 72 hours post-administration', 'eventGroups': [{'id': 'EG000', 'title': 'OCT (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state', 'otherNumAtRisk': 18, 'otherNumAffected': 6, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'OCT (After Meal)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal', 'otherNumAtRisk': 17, 'otherNumAffected': 7, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'OCT (Before Meal)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered before consumption of a standard breakfast', 'otherNumAtRisk': 14, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'DFC (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state', 'otherNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Infusion site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tongue Blistering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state'}, {'id': 'OG001', 'title': 'DFC (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state'}], 'classes': [{'categories': [{'measurements': [{'value': '763.76', 'groupId': 'OG000', 'lowerLimit': '579.52', 'upperLimit': '1681.47'}, {'value': '776.41', 'groupId': 'OG001', 'lowerLimit': '470.04', 'upperLimit': '1698.00'}]}]}], 'analyses': [{'pValue': '>0.200', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.98', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.05', 'groupDescription': 'OCT (fasted)/DFC (fasted)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Geometric Mean Ratio of OCT (fasted)/DFC (fasted)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From study drug administration to 72 hours post-administration', 'unitOfMeasure': 'nM*hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with AUC(0-∞) measurements'}, {'type': 'PRIMARY', 'title': 'Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state'}, {'id': 'OG001', 'title': 'DFC (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state'}], 'classes': [{'categories': [{'measurements': [{'value': '241.37', 'groupId': 'OG000', 'lowerLimit': '96.84', 'upperLimit': '607.42'}, {'value': '246.92', 'groupId': 'OG001', 'lowerLimit': '78.17', 'upperLimit': '539.93'}]}]}], 'analyses': [{'pValue': '>0.200', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.98', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.19', 'groupDescription': 'OCT (fasted)/DFC (fasted)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Geometric Mean Ratio of OCT (fasted)/DFC (fasted)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From study drug administration to 72 hours post-administration', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with Cmax measurements'}, {'type': 'SECONDARY', 'title': 'AUC(0-∞) for OCT (Fasted) and OCT (After Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state'}, {'id': 'OG001', 'title': 'OCT (After Meal)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal'}], 'classes': [{'categories': [{'measurements': [{'value': '763.76', 'groupId': 'OG000', 'lowerLimit': '579.52', 'upperLimit': '1681.47'}, {'value': '702.08', 'groupId': 'OG001', 'lowerLimit': '467.62', 'upperLimit': '1375.86'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.92', 'ciLowerLimit': '0.86', 'ciUpperLimit': '0.98', 'groupDescription': 'OCT (after meal)/OCT (fasted)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Geometric Mean Ratio of OCT (after meal)/OCT (fasted)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From study drug administration to 72 hours post-administration', 'unitOfMeasure': 'nM*hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with AUC(0-∞) measurements'}, {'type': 'SECONDARY', 'title': 'Cmax of OCT (Fasted) and OCT (After Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state'}, {'id': 'OG001', 'title': 'OCT (After Meal)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal'}], 'classes': [{'categories': [{'measurements': [{'value': '241.37', 'groupId': 'OG000', 'lowerLimit': '96.84', 'upperLimit': '607.42'}, {'value': '143.51', 'groupId': 'OG001', 'lowerLimit': '64.13', 'upperLimit': '268.08'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.59', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.72', 'groupDescription': 'OCT (after meal)/OCT (fasted)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Geometric Mean Ratio OCT (after meal)/OCT (fasted)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From study drug administration to 72 hours post-administration', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with Cmax measurements'}, {'type': 'PRIMARY', 'title': 'Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state'}, {'id': 'OG001', 'title': 'DFC (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '4.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '1.50'}]}]}], 'analyses': [{'pValue': '>0.200', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'OCT (fasted)/DFC (fasted)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From study drug administration to 72 hours post-administration', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with Tmax measurements'}, {'type': 'PRIMARY', 'title': 'Half Life (t½) for OCT (Fasted) and DFC (Fasted)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state'}, {'id': 'OG001', 'title': 'DFC (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state'}], 'classes': [{'categories': [{'measurements': [{'value': '9.85', 'groupId': 'OG000', 'lowerLimit': '3.90', 'upperLimit': '27.00'}, {'value': '8.05', 'groupId': 'OG001', 'lowerLimit': '5.30', 'upperLimit': '38.40'}]}]}], 'analyses': [{'pValue': '>0.200', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'OCT (fasted)/DFC (fasted)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From study drug administration to 72 hours post-administration', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with t1/2 measurements'}, {'type': 'SECONDARY', 'title': 'Tmax for OCT (Fasted) and OCT (After Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state'}, {'id': 'OG001', 'title': 'OCT (After Meal)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '4.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'OCT (after meal)/OCT (fasted)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From study drug administration to 72 hours post-administration', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with Tmax measurements'}, {'type': 'SECONDARY', 'title': 't1/2 for OCT (Fasted) and OCT (After Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT (Fasted)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state'}, {'id': 'OG001', 'title': 'OCT (After Meal)', 'description': 'Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal'}], 'classes': [{'categories': [{'measurements': [{'value': '9.85', 'groupId': 'OG000', 'lowerLimit': '3.90', 'upperLimit': '27.00'}, {'value': '9.60', 'groupId': 'OG001', 'lowerLimit': '3.30', 'upperLimit': '23.20'}]}]}], 'analyses': [{'pValue': '>0.200', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'OCT (after meal)/OCT (fasted)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From study drug administration to 72 hours post-administration', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with t1/2 measurements'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group ABCD', 'description': '* Period 1: Dry Filled Capsule (DFC) (fasted)\n* Period 2: Oral Compressed Tablet (OCT) (fasted)\n* Period 3: OCT (after meal)\n* Period 4: OCT (before meal)'}, {'id': 'FG001', 'title': 'Treatment Group BACD', 'description': '* Period 1: OCT (fasted)\n* Period 2: DFC (fasted)\n* Period 3: OCT (after meal)\n* Period 4: OCT (before meal)'}, {'id': 'FG002', 'title': 'Treatment Group BCD', 'description': '* Period 1: Not Applicable\n* Period 2: OCT (fasted)\n* Period 3: OCT (after meal)\n* Period 4: OCT (before meal)'}], 'periods': [{'title': 'Treatment Period 1 (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 1 (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'comment': '3 new participants added to Treatment Group ABCD \\& received treatment sequence BCD for Periods 2-4', 'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 2 (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3 (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 3 (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 4 (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Randomized', 'description': 'Includes the 15 participants who were randomized and started the study in Treatment Period 1 (Baseline) and the 3 additional participants who were subsequently randomized and started the study in Treatment Period 2.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '≥ 35 and ≤ 69 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-12', 'studyFirstSubmitDate': '2007-11-30', 'resultsFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2007-11-30', 'lastUpdatePostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-02', 'studyFirstPostDateStruct': {'date': '2007-12-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)', 'timeFrame': 'From study drug administration to 72 hours post-administration'}, {'measure': 'Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)', 'timeFrame': 'From study drug administration to 72 hours post-administration'}, {'measure': 'Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)', 'timeFrame': 'From study drug administration to 72 hours post-administration'}, {'measure': 'Half Life (t½) for OCT (Fasted) and DFC (Fasted)', 'timeFrame': 'From study drug administration to 72 hours post-administration'}], 'secondaryOutcomes': [{'measure': 'AUC(0-∞) for OCT (Fasted) and OCT (After Meal)', 'timeFrame': 'From study drug administration to 72 hours post-administration'}, {'measure': 'Cmax of OCT (Fasted) and OCT (After Meal)', 'timeFrame': 'From study drug administration to 72 hours post-administration'}, {'measure': 'Tmax for OCT (Fasted) and OCT (After Meal)', 'timeFrame': 'From study drug administration to 72 hours post-administration'}, {'measure': 't1/2 for OCT (Fasted) and OCT (After Meal)', 'timeFrame': 'From study drug administration to 72 hours post-administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) \\& oral compressed tablet (OCT) formulations of MK-0941-009 \\& to assess the effect of food on the OCT formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females (of non-childbearing potential) between the ages of 18 to 70\n* Participants have been diagnosed with Type 2 Diabetes\n* Participants are nonsmokers for at least 6 months\n\nExclusion Criteria:\n\n* Participant should not be diagnosed with Type 1 diabetes\n* Participant should not be receiving insulin or PPAR gamma agonists for 12 weeks prior to study start\n* Participant has a recent history of eye infection or other inflammatory eye condition within 2 weeks prior to study start\n* Participant has been diagnosed with glaucoma or is blind\n* Participant has had trauma to one or both eyes\n* Participant has had major surgery, donated blood or participated in another clinical study in the past 4 weeks\n* Participant is a regular user of illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months'}, 'identificationModule': {'nctId': 'NCT00567112', 'briefTitle': 'Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Randomized, Partially Fixed-Sequence, 4-Period Crossover Study to Assess the Pharmacokinetics After Administration of the DFC and OCT Formulations and the Food Effect on the OCT Formulation of MK-0941 in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '0941-009'}, 'secondaryIdInfos': [{'id': '2007_652', 'type': 'OTHER', 'domain': 'Merck Registration ID'}, {'id': 'MK-0941-009', 'type': 'OTHER', 'domain': 'Merck Protocol ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DFC (fasted)', 'interventionNames': ['Drug: 10 mg MK-0941 DFC (fasted)']}, {'type': 'EXPERIMENTAL', 'label': 'OCT (fasted)', 'interventionNames': ['Drug: 10 mg MK-0941 OCT (fasted)']}, {'type': 'EXPERIMENTAL', 'label': 'OCT (after meal)', 'interventionNames': ['Drug: 10 mg MK-0941 OCT (after meal)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OCT (before meal)', 'interventionNames': ['Drug: 10 mg MK-0941 OCT (before meal)']}], 'interventions': [{'name': '10 mg MK-0941 DFC (fasted)', 'type': 'DRUG', 'description': 'single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state', 'armGroupLabels': ['DFC (fasted)']}, {'name': '10 mg MK-0941 OCT (after meal)', 'type': 'DRUG', 'description': 'single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal', 'armGroupLabels': ['OCT (after meal)']}, {'name': '10 mg MK-0941 OCT (before meal)', 'type': 'DRUG', 'description': 'single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast', 'armGroupLabels': ['OCT (before meal)']}, {'name': '10 mg MK-0941 OCT (fasted)', 'type': 'DRUG', 'description': 'single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state', 'armGroupLabels': ['OCT (fasted)']}]}, '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'}}}}