Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-28 @ 5:08 AM
Study NCT ID:
NCT01065766
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2010-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000068899', 'term': 'Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-888-577-8839', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'In regard to surveillance result, any publication should be agreed by sponsor in advance.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 26 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants Included in the Safety Evaluation', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin', 'otherNumAtRisk': 4033, 'otherNumAffected': 0, 'seriousNumAtRisk': 4033, 'seriousNumAffected': 17}], 'seriousEvents': [{'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'ATRIAL FLUTTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'CORONARY ARTERY OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'OESOPHAGEAL VARICES HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'BILE DUCT STONE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'CHRONIC HEPATITIS C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'HYPERLIPIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'THYROID NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'TENSION HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'KNEE ARTHROPLASTY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Any Adverse Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4033', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Included in the Safety Evaluation', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '3.74', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 26 weeks', 'description': 'An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were included in the safety evaluation'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1597', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Included in the Safety Evaluation', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.93', 'spread': '1.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.', 'unitOfMeasure': 'Percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a pre-treatment and a 12-week post-treatment HbA1c value.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1343', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Included in the Safety Evaluation', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.21', 'spread': '42.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a pre-treatment and a 12-week post-treatment measurement of FPG.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Included in the Safety Evaluation', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '-58.02', 'spread': '72.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a pre-treatment and a 12-week post-treatment measurement of 2hr-PPG.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Included in the Safety Evaluation', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '78.68', 'groupId': 'OG000'}]}]}, {'title': 'Stable', 'categories': [{'measurements': [{'value': '16.38', 'groupId': 'OG000'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '4.94', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', 'description': 'Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator\'s global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Treatment in HbA1c at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Included in the Safety Evaluation', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.08', 'spread': '1.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.', 'unitOfMeasure': 'Percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a pre-treatment and a 24-week post-treatment HbA1c value.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Treatment in FPG at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Included in the Safety Evaluation', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.40', 'spread': '44.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a pre-treatment and a 24-week post-treatment measurement of FPG.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in 2hr-PPG at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Included in the Safety Evaluation', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '-62.13', 'spread': '75.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a pre-treatment and a 24-week post-treatment measurement of 2hr-PPG.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '800', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Included in the Safety Evaluation', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '76.38', 'groupId': 'OG000'}]}]}, {'title': 'Stable', 'categories': [{'measurements': [{'value': '15.88', 'groupId': 'OG000'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '7.75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 24', 'description': 'Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator\'s global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants Included in the Safety Evaluation', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4065'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4033'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Assessed before the contracted date', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Contraindication to administration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Violated dosage/administration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}]}]}], 'recruitmentDetails': 'In this post-marketing surveillance study of sitagliptin/metformin (JANUMET®), participants in South Korea treated for \\>= 24 weeks were evaluated for long-term safety and efficacy. During the re-examination study period (December 4, 2005 to September 20, 2013), case report forms (CRFs) were collected from 4,065 participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4033', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants Included in the Safety Evaluation', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.22', 'spread': '11.55', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1913', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2120', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics were only reported for the Safety Population (4033) who qualified for the study and not for the 4065 participants from whom CRFs were collected.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4065}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-18', 'studyFirstSubmitDate': '2010-02-08', 'resultsFirstSubmitDate': '2014-03-11', 'studyFirstSubmitQcDate': '2010-02-08', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-11', 'studyFirstPostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Any Adverse Experience', 'timeFrame': 'Up to 26 weeks', 'description': 'An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.'}, {'measure': 'Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.'}, {'measure': 'Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.'}, {'measure': 'Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.'}, {'measure': 'Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12', 'timeFrame': 'At Week 12', 'description': 'Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator\'s global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.'}, {'measure': 'Change From Baseline to Treatment in HbA1c at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.'}, {'measure': 'Change From Baseline to Treatment in FPG at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.'}, {'measure': 'Change From Baseline in 2hr-PPG at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.'}, {'measure': 'Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24', 'timeFrame': 'At Week 24', 'description': 'Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator\'s global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Non-Insulin-Dependent'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin in usual practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has type 2 diabetes mellitus\n* Is treated with sitagliptin/metformin within local label for the first time\n\nExclusion Criteria:\n\n* Has a contraindication to sitagliptin/metformin according to the local label\n* Is treated with sitagliptin/metformin before contract and out of enrollment period'}, 'identificationModule': {'nctId': 'NCT01065766', 'briefTitle': 'Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of JANUMET in Usual Practice', 'orgStudyIdInfo': {'id': '0431A-182'}, 'secondaryIdInfos': [{'id': '2010_006', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants', 'description': 'Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin', 'interventionNames': ['Drug: Sitagliptin/metformin']}], 'interventions': [{'name': 'Sitagliptin/metformin', 'type': 'DRUG', 'otherNames': ['JANUMET'], 'description': 'Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.', 'armGroupLabels': ['All participants']}]}, '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'}}}}