Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-04 @ 7:41 PM
Study NCT ID:
NCT01903356
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2013-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit.', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.', 'eventGroups': [{'id': 'EG000', 'title': 'TrajentaDuo® Tablet', 'description': 'Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet', 'otherNumAtRisk': 709, 'deathsNumAtRisk': 709, 'otherNumAffected': 0, 'seriousNumAtRisk': 709, 'deathsNumAffected': 0, 'seriousNumAffected': 15}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Mediastinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Vocal cord polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 709, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TrajentaDuo® Tablet', 'description': 'Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.75', 'spread': '1.48', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Comparison of % of HbA1c before and 24 weeks after administration of TrajentaDuo® Tablet treatment.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Wilcoxon signed rank test has been used for this analysis.', 'otherAnalysisDescription': 'The difference considered in the analysis is HbA1c values after drug administration minus HbA1c values before drug administration'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': "This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.", 'unitOfMeasure': 'Percentage (%) of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.'}, {'type': 'SECONDARY', 'title': 'Target Effectiveness Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TrajentaDuo® Tablet', 'description': 'Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '33.06', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Weeks', 'description': 'Occurrence of treatment to target effectiveness response is an HbA1c under treatment of \\< 6.5% after 24 weeks of treatment. This outcome measures percentage of patients achieving HbA1c \\< 6.5% after 24 weeks.', 'unitOfMeasure': 'Percentage of Patients (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.'}, {'type': 'SECONDARY', 'title': 'Relative Effectiveness Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TrajentaDuo® Tablet', 'description': 'Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '46.78', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Weeks', 'description': 'Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks.', 'unitOfMeasure': 'Percentage of patients (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TrajentaDuo® Tablet', 'description': 'Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.12', 'spread': '52.60', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Comparison of FPG before and 24 weeks after administration of TrajentaDuo® Tablet treatment', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Wilcoxon signed rank test has been used for this analysis.', 'otherAnalysisDescription': 'The difference considered in the analysis is FPG values after drug administration minus FPG values before drug administration'}], 'paramType': 'MEAN', 'timeFrame': '24 Weeks', 'description': "This outcome has measured difference between Fasting Plasma Glucose (FPG) values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication.", 'unitOfMeasure': 'Milligram/deciLitre (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.'}, {'type': 'PRIMARY', 'title': 'Incidence Rate of Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '709', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TrajentaDuo® Tablet', 'description': 'Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '11.99', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 26 weeks', 'description': 'The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo', 'unitOfMeasure': 'Percentage of patients (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TrajentaDuo® Tablet', 'description': 'Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '724'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '709'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Violated inclusion/exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Violated the dosage and administration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This is an observational study in patients with type 2 diabetes mellitus who had been administered with TrajentaDuo® Tablets. The Case Report Forms of 724 subjects investigated by 15 investigators at 14 hospitals were retrieved from November 15, 2012 up to September 13, 2017.', 'preAssignmentDetails': 'All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be enrolled in the study if any one of the specific entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '709', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TrajentaDuo® Tablet', 'description': 'Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '709', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62.04', 'spread': '11.56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age of all patients enrolled in the study', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '709', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '358', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '351', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender distribution of all patients enrolled in the study', 'unitOfMeasure': 'Participants', 'populationDescription': 'Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Hemoglobin A1c (HbA1c) at baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.78', 'spread': '1.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c values measured at baseline in percent. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.', 'unitOfMeasure': 'Percentage of HbA1c (%)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.'}], 'populationDescription': 'Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-22', 'size': 438775, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-05T23:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 724}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-08', 'studyFirstSubmitDate': '2013-07-16', 'resultsFirstSubmitDate': '2018-06-08', 'studyFirstSubmitQcDate': '2013-07-16', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-08', 'studyFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Adverse Events (AE)', 'timeFrame': 'Up to 26 weeks', 'description': 'The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.', 'timeFrame': 'Baseline and Week 24', 'description': "This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range."}, {'measure': 'Target Effectiveness Response Rate', 'timeFrame': '24 Weeks', 'description': 'Occurrence of treatment to target effectiveness response is an HbA1c under treatment of \\< 6.5% after 24 weeks of treatment. This outcome measures percentage of patients achieving HbA1c \\< 6.5% after 24 weeks.'}, {'measure': 'Relative Effectiveness Response Rate', 'timeFrame': '24 Weeks', 'description': 'Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.', 'timeFrame': '24 Weeks', 'description': "This outcome has measured difference between Fasting Plasma Glucose (FPG) values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication."}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.', 'detailedDescription': 'Study Design:\n\nPost Marketed Study- Observational study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Korean patients with T2DM', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPotential subjets must meet all of the following inclusion criteria to enter this trial:\n\n1. No previous exposure to Trajenta, Trajenta Duo\n2. Should have been started on Trajenta Duo in accordance with the approved label in Korea\n3. No current participation in clinical trials\n4. No metformin is inappropriate due to contraindications\n5. Must sign on the data release consent form\n\nExclusion criteria:\n\nIndividuals with any of the following characteristics will not be able to enter this study:\n\n1. Previous exposure to Trajenta, Trajenta Duo\n2. Current participation in clinical trials\n3. Patients for whom metformin is inappropriate due to contraindications'}, 'identificationModule': {'nctId': 'NCT01903356', 'briefTitle': 'A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta Duo® (Linagliptin/Metformin HCl, 2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg, b.i.d) in Korean Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '1288.22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with T2DM', 'interventionNames': ['Drug: Trajenta duo']}], 'interventions': [{'name': 'Trajenta duo', 'type': 'DRUG', 'description': 'Linagliptin and Metformin', 'armGroupLabels': ['Patients with T2DM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'South Korea'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}