Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-06 @ 6:01 PM
Study NCT ID:
NCT03338803
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2017-11-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Real World Glycemic Effectiveness of Linagliptin
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069476', 'term': 'Linagliptin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Centre', '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': 'Individual safety reporting is not applicable for this study', 'description': 'This is a retrospective observational study using secondary data, in which all patient data will be collected and analyzed in aggregate. Individual patient safety related information will not be captured during this study. Thus, individual safety reporting is not applicable for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients With Written Prescription for Initiating Linagliptin', 'description': 'Patients with a first written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Written Prescription for Initiating Linagliptin', 'description': 'Patients with a first written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.51', 'spread': '1.46', 'groupId': 'OG000'}]}]}, {'title': 'Age 40 to 54 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2325', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.65', 'spread': '1.65', 'groupId': 'OG000'}]}]}, {'title': 'Age 55 to 64 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3332', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.59', 'spread': '1.54', 'groupId': 'OG000'}]}]}, {'title': 'Age 65 to 74 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3077', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.43', 'spread': '1.36', 'groupId': 'OG000'}]}]}, {'title': 'Age 75+ years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '1.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 60 to 180 days', 'description': "Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years).\n\nChange in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date.", 'unitOfMeasure': 'Percentage (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.'}, {'type': 'PRIMARY', 'title': 'Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Written Prescription for Initiating Linagliptin', 'description': 'Patients with a first written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.51', 'spread': '1.46', 'groupId': 'OG000'}]}]}, {'title': 'eGFR<30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '679', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '1.46', 'groupId': 'OG000'}]}]}, {'title': 'eGFR 30 to 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1646', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'eGFR 45 to 59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1727', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'spread': '1.42', 'groupId': 'OG000'}]}]}, {'title': 'eGFR 60 to 89', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3256', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'spread': '1.44', 'groupId': 'OG000'}]}]}, {'title': 'eGFR ≥ 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2603', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.70', 'spread': '1.58', 'groupId': 'OG000'}]}]}, {'title': 'eGFR not available', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1090', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '1.40', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 60 to 180 days', 'description': "Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories.\n\nChange in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR\\<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR ≥ 90 milliliter/ minute/1.73 meter\\^2 and eGFR not available).", 'unitOfMeasure': 'Percentage (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.'}, {'type': 'SECONDARY', 'title': 'Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Written Prescription for Initiating Linagliptin', 'description': 'Patients with a first written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.72', 'groupId': 'OG000'}]}]}, {'title': 'Age 40 to 54 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2325', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.28', 'groupId': 'OG000'}]}]}, {'title': 'Age 55 to 64 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3332', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.59', 'groupId': 'OG000'}]}]}, {'title': 'Age 65 to 74 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3077', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.89', 'groupId': 'OG000'}]}]}, {'title': 'Age 75+ years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.55', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 to 180 days', 'description': 'Percentage of adults with T2DM who achieve HbA1c \\< 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years).', 'unitOfMeasure': 'Percentage of patients (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.'}, {'type': 'SECONDARY', 'title': 'Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Written Prescription for Initiating Linagliptin', 'description': 'Patients with a first written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.72', 'groupId': 'OG000'}]}]}, {'title': 'eGFR<30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '679', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.69', 'groupId': 'OG000'}]}]}, {'title': 'eGFR 30 to 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1646', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.88', 'groupId': 'OG000'}]}]}, {'title': 'eGFR 45 to 59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1727', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.19', 'groupId': 'OG000'}]}]}, {'title': 'eGFR 60 to 89', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3256', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.75', 'groupId': 'OG000'}]}]}, {'title': 'eGFR ≥ 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2603', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.12', 'groupId': 'OG000'}]}]}, {'title': 'eGFR not available', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1090', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.37', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 to 180 days', 'description': 'Percentage of adults with T2DM who achieve HbA1c \\< 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR\\<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR ≥ 90 milliliter/ minute /1.73 meter\\^2 and eGFR not available).', 'unitOfMeasure': 'Percentage of patients (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Written Prescription for Initiating Linagliptin', 'description': 'Patients with a first written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11001'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11001'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Non-interventional, retrospective cohort study using existing data from patients in the Optum Clinical Database which contains electronic health record (EHR) data for the period of 01 July 2011 through 31 March 2017.', 'preAssignmentDetails': 'Type 2 diabetes mellitus (T2DM) patients with written prescription for initiating Linagliptin (Tradjenta®, Jentadueto®, or Jentadueto XR®) were identified during identification period starting on 01 January 2012 and ending on 30 September 2016. Aim was to describe real world glycemic-lowering effectiveness across range of ages and renal function.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Written Prescription for Initiating Linagliptin', 'description': 'Patients with a first written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.30', 'spread': '11.37', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5603', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5398', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '927', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9550', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '524', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '241', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1455', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8645', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '660', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Estimated glomerular filtration rate (eGFR)', 'classes': [{'title': '<30', 'categories': [{'measurements': [{'value': '679', 'groupId': 'BG000'}]}]}, {'title': '30 to 44', 'categories': [{'measurements': [{'value': '1646', 'groupId': 'BG000'}]}]}, {'title': '45 to 59', 'categories': [{'measurements': [{'value': '1727', 'groupId': 'BG000'}]}]}, {'title': '60 to 89', 'categories': [{'measurements': [{'value': '3256', 'groupId': 'BG000'}]}]}, {'title': '≥ 90', 'categories': [{'measurements': [{'value': '2603', 'groupId': 'BG000'}]}]}, {'title': 'eGFR not available', 'categories': [{'measurements': [{'value': '1090', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants by study specific estimated glomerular filtration rate (eGFR) categories is presented.', 'unitOfMeasure': 'participants'}, {'title': 'Age categories', 'classes': [{'title': '40 to 54 years', 'categories': [{'measurements': [{'value': '2325', 'groupId': 'BG000'}]}]}, {'title': '55 to 64 years', 'categories': [{'measurements': [{'value': '3332', 'groupId': 'BG000'}]}]}, {'title': '65 to 74 years', 'categories': [{'measurements': [{'value': '3077', 'groupId': 'BG000'}]}]}, {'title': '75 years and above', 'categories': [{'measurements': [{'value': '2267', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants by study specific age categories is presented', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-20', 'size': 373360, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-01T08:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11001}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2017-11-08', 'resultsFirstSubmitDate': '2019-02-01', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-01', 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories', 'timeFrame': 'Baseline and 60 to 180 days', 'description': "Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years).\n\nChange in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date."}, {'measure': 'Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories', 'timeFrame': 'Baseline and 60 to 180 days', 'description': "Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories.\n\nChange in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR\\<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR ≥ 90 milliliter/ minute/1.73 meter\\^2 and eGFR not available)."}], 'secondaryOutcomes': [{'measure': 'Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories', 'timeFrame': '60 to 180 days', 'description': 'Percentage of adults with T2DM who achieve HbA1c \\< 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years).'}, {'measure': 'Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories', 'timeFrame': '60 to 180 days', 'description': 'Percentage of adults with T2DM who achieve HbA1c \\< 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR\\<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR ≥ 90 milliliter/ minute /1.73 meter\\^2 and eGFR not available).'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'A non-interventional cohort study using existing data from patients in the Optum Clinical Database which contains electronic health record (EHR) data from providers across the United States to determine whether there is comparable effectiveness of linagliptin on glycemic effectiveness'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A non-interventional cohort study using existing data from patients in the Optum Clinical Database which contains electronic health record (EHR) data from providers across the United States to determine whether there is comparable effectiveness of linagliptin on glycemic effectivenes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 1 written prescription for linagliptin (Tradjenta®, Jentadueto®, or Jentadueto XR®)in the EHR (electronic health record) data during the identification period\n* ≥ 40 years of age based on the year of the index date\n* First active date in the EHR is ≥ 180 days prior to the index date\n* ≥ 1 diagnosis code representing Type 2 diabetes (T2DM) in the EHR data during the 180-day pre-index period or on the index date\n* ≥ 1 HbA1c value during the 180-day pre-index period or on the index date\n* ≥ 1 HbA1c value 60 to 180 days after the index date\n\nExclusion Criteria:\n\n* ≥ 1 written prescription, medication administration or medication history record for linagliptin or other dipeptidyl peptidase (DPP-4) inhibitor in the EHR data during the 180-day pre-index period\n* ≥ 1 written prescription or medication administration for a new antihyperglycemic medication other than linagliptin on the index date New antihyperglycemic medication will be defined as a written prescription or medication administration for any antihyperglycemic medication that was not present in the patient\'s written prescription, medication administration, or medication history records during the 180-day pre-index period.\n\nIndividual antihyperglycemic medications will be distinguished by generic name using the column labelled "Medication Name" in Tables 2 through 13. Combination products containing two generic ingredients will be considered as two distinct antihyperglycemic medications Note: This exclusion criterion is designed to exclude patients from the study sample if they start a new antihyperglycemic medication other than linagliptin on the index date. Patients that start a new antihyperglycemic medication in the follow-up period will not be removed from the study sample to avoid creating a biased sample. Addition of a new antihyperglycemic medication during follow-up will be evaluated through the sensitivity analysis described in Section 9.7.4.4. While we will be capturing additions of new therapies, discontinuation of linagliptin is not able to be accurately measured in electronic record data. The electronic record data capture prescriptions written by a prescriber, but it is not possible to know if patients received and adhered to their medication and there are no structured data fields to identify if and when a medication was discontinued by the patient or the provider\n\n* ≥ 1 diagnosis code or procedure code representing renal transplant, solid organ transplant, or bone marrow transplant in the EHR data during the 180-day pre-index period or on the index date\n* ≥ 1 diagnosis code representing malignancy in the EHR data during the 180-day preindex period or on the index date'}, 'identificationModule': {'nctId': 'NCT03338803', 'briefTitle': 'Real World Glycemic Effectiveness of Linagliptin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Real World Glycemic Effectiveness of Linagliptin Among Type 2 Diabetes Mellitus Adults by Age and Renal Function', 'orgStudyIdInfo': {'id': '1218-0182'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with a written prescription for linagliptin', 'interventionNames': ['Drug: Linagliptin']}], 'interventions': [{'name': 'Linagliptin', 'type': 'DRUG', 'otherNames': ['ONDERO, TRAJENTA, TRAYENTA, TRAZENTA, TRADJENTA'], 'description': 'drug', 'armGroupLabels': ['Patients with a written prescription for linagliptin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55344', 'city': 'Eden Prairie', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Optum', 'geoPoint': {'lat': 44.85469, 'lon': -93.47079}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}