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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
This protocol is for a series of comparative effectiveness and safety analyses within periodically updated cohorts of patients initiating linagliptin, other DPP-4 inhibitors, and other oral hypoglycemic medications, followed longitudinally for the occurrence of a variety of health outcomes. The primary analysis will be conducted among patients without prior within-class medication use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glitazones | |||
| Linagliptin | |||
| Sulfonylurea | |||
| Within-class comparators |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Adverse Cardiovascular Event | Number of participants with major adverse cardiovascular event is presented by the number of patients reported a composite of:
| Up to 5 years and 7 months |
| Number of Participants With Coronary Revascularization | Number of participants with coronary revascularization (elective and non-elective procedure) | Up to 5 years and 7 month |
| Number of Participants With Acute Coronary Syndrome | Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately. | Up to 5 years and 7 months |
| Number of Participants With Stroke | Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately | Up to 5 years and 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Heart Failure Hospitalization | Number of participants with heart failure hospitalization | Up to 5 years and 7 months |
| Number of Participants With Incident End Stage Renal Disease |
Not provided
Inclusion criteria:
Exclusion criteria:
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T2DM patients aged 18 or older, initiating antidiabetic treatment after at least 6 months of continuous enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States |
Only participants with no use of a medication in the same class or comparator class during the 6 months prior to index date, who were at least 18 years of age and enrolled for a minimum of 6 months in the data source before treatment initiation were included.
From Clinformatics and MarketScan source data, patients with a recorded diagnosis of type 2 diabetes mellitus (T2DM) who initiated linagliptin, sitagliptin, saxagliptin, alogliptin, pioglitazone, or 2nd generation sulfonylureas were identified between May 2011 and December 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Other DPP-4I - Clinformatics | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database |
| FG001 | Linagliptin 1 - Clinformatics | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database |
| FG002 | Pioglitazone - Clinformatics | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database |
| FG003 | Linagliptin 2 - Clinformatics | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database |
| FG004 | 2nd Gen SUs - Clinformatics | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database |
| FG005 | Linagliptin 3 - Clinformatics | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database |
| FG006 | Other DPP-4I - MarketScan | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database |
| FG007 | Linagliptin 1 - MarketScan | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database |
| FG008 | Pioglitazone - MarketScan | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database |
| FG009 | Linagliptin 2 - MarketScan | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database |
| FG010 | 2nd Gen SUs - MarketScan | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| FG011 | Linagliptin 3 - MarketScan | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants, who initiated linagliptin, other DPP-4, pioglitazone, or second generation sulfonylureas, were identified from Clinformatics and MarketScan between May 2011 and December 2016.Within each database, a 1:1 propensity score matching was performed between initiators of linagliptin and intiators of each comparator group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Other DPP-4I - Clinformatics | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database |
| BG001 | Linagliptin 1 - Clinformatics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Major Adverse Cardiovascular Event | Number of participants with major adverse cardiovascular event is presented by the number of patients reported a composite of:
| 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016 | Posted | Number | Participants | Up to 5 years and 7 months |
|
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As this is a non-interventional study with secondary use of data retrieved from a US health claims database, safety monitoring and safety reporting on an individual case level is not applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Other DPP-4I - Clinformatics | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database |
Not provided
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Pioglitazone is contraindicated among patients with heart failure and edema. This suggests pioglitazone may not be a proper comparator in the assessment of the association between linagliptin and heart failure hospitalization or renal outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2014 | Mar 19, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Number of participants with incident end stage renal disease (ESRD)
| Up to 5 years and 7 months |
| Number of Participants With Acute Renal Failure | Number of participants with acute renal failure | Up to 5 years and 7 months |
| Number of Participants With Acute Renal Failure Requiring Dialysis | Number of patients with acute renal failure requiring dialysis | Up to 5 years and 7 months |
1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database
| BG002 | Pioglitazone - Clinformatics | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database |
| BG003 | Linagliptin 2 - Clinformatics | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database |
| BG004 | 2nd Gen SUs - Clinformatics | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database |
| BG005 | Linagliptin 3 - Clinformatics | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database |
| BG006 | Other DPP-4I - MarketScan | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database |
| BG007 | Linagliptin 1 - MarketScan | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database |
| BG008 | Pioglitazone - MarketScan | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database |
| BG009 | Linagliptin 2 - MarketScan | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database |
| BG010 | 2nd Gen SUs - MarketScan | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| BG011 | Linagliptin 3 - MarketScan | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| BG012 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| Linagliptin 1 - Clinformatics |
1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database |
| OG002 | Pioglitazone - Clinformatics | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database |
| OG003 | Linagliptin 2 - Clinformatics | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database |
| OG004 | 2nd Gen SUs - Clinformatics | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database |
| OG005 | Linagliptin 3 - Clinformatics | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database |
| OG006 | Other DPP-4I - MarketScan | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database |
| OG007 | Linagliptin 1 - MarketScan | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database |
| OG008 | Pioglitazone - MarketScan | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database |
| OG009 | Linagliptin 2 - MarketScan | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database |
| OG010 | 2nd Gen SUs - MarketScan | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| OG011 | Linagliptin 3 - MarketScan | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
|
|
|
| Primary | Number of Participants With Coronary Revascularization | Number of participants with coronary revascularization (elective and non-elective procedure) | 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016. | Posted | Number | Participants | Up to 5 years and 7 month |
|
|
|
|
| Primary | Number of Participants With Acute Coronary Syndrome | Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately. | 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016. | Posted | Number | Participants | Up to 5 years and 7 months |
|
|
|
|
| Primary | Number of Participants With Stroke | Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately | 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016. | Posted | Number | Participants | Up to 5 years and 7 months |
|
|
|
|
| Secondary | Number of Participants With Heart Failure Hospitalization | Number of participants with heart failure hospitalization | 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016. | Posted | Number | Participants | Up to 5 years and 7 months |
|
|
|
|
| Secondary | Number of Participants With Incident End Stage Renal Disease | Number of participants with incident end stage renal disease (ESRD) | 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016. For this outcome only, patients with ESRD at any time prior to and including the day of treatment initiation were excluded. | Posted | Number | Participants | Up to 5 years and 7 months |
|
|
|
|
| Secondary | Number of Participants With Acute Renal Failure | Number of participants with acute renal failure | 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016. | Posted | Number | Participants | Up to 5 years and 7 months |
|
|
|
|
| Secondary | Number of Participants With Acute Renal Failure Requiring Dialysis | Number of patients with acute renal failure requiring dialysis | 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016. | Posted | Number | Participants | Up to 5 years and 7 months |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Linagliptin 1 - Clinformatics | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Pioglitazone - Clinformatics | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Linagliptin 2 - Clinformatics | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | 2nd Gen SUs - Clinformatics | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Linagliptin 3 - Clinformatics | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | Other DPP-4I - MarketScan | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 0 | 0 | 0 | 0 | 0 | 0 |
| EG007 | Linagliptin 1 - MarketScan | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 0 | 0 | 0 | 0 | 0 | 0 |
| EG008 | Pioglitazone - MarketScan | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 0 | 0 | 0 | 0 | 0 | 0 |
| EG009 | Linagliptin 2 - MarketScan | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 0 | 0 | 0 | 0 | 0 | 0 |
| EG010 | 2nd Gen SUs - MarketScan | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 0 | 0 | 0 | 0 | 0 | 0 |
| EG011 | Linagliptin 3 - MarketScan | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| Male |
|
| Hazard Ratio (HR) |
| 0.81 |
| 2-Sided |
| 95 |
| 0.57 |
| 1.16 |
| Other |
| Hazard Ratio (HR) | 0.70 | 2-Sided | 95 | 0.48 | 1.01 | Other |
| Hazard Ratio (HR) | 1.04 | 2-Sided | 95 | 0.85 | 1.28 | Other |
| Hazard Ratio (HR) | 1.01 | 2-Sided | 95 | 0.79 | 1.28 | Other |
| Hazard Ratio (HR) | 0.81 | 2-Sided | 95 | 0.62 | 1.06 | Other |
| Hazard Ratio (HR) |
| 0.63 |
| 2-Sided |
| 95 |
| 0.44 |
| 0.90 |
| Other |
| Hazard Ratio (HR) | 0.60 | 2-Sided | 95 | 0.41 | 0.88 | Other |
| Hazard Ratio (HR) | 0.97 | 2-Sided | 95 | 0.81 | 1.17 | Other |
| Hazard Ratio (HR) | 0.96 | 2-Sided | 95 | 0.77 | 1.19 | Other |
| Hazard Ratio (HR) | 0.76 | 2-Sided | 95 | 0.60 | 0.97 | Other |
| Hazard Ratio (HR) |
| 0.99 |
| 2-Sided |
| 95 |
| 0.60 |
| 1.64 |
| Other |
| Hazard Ratio (HR) | 0.44 | 2-Sided | 95 | 0.24 | 0.78 | Other |
| Hazard Ratio (HR) | 0.96 | 2-Sided | 95 | 0.73 | 1.25 | Other |
| Hazard Ratio (HR) | 1.09 | 2-Sided | 95 | 0.78 | 1.52 | Other |
| Hazard Ratio (HR) | 0.74 | 2-Sided | 95 | 0.52 | 1.05 | Other |
| Hazard Ratio (HR) |
| 1.90 |
| 2-Sided |
| 95 |
| 1.19 |
| 3.03 |
| Other |
| Hazard Ratio (HR) | 1.11 | 2-Sided | 95 | 0.73 | 1.68 | Other |
| Hazard Ratio (HR) | 0.99 | 2-Sided | 95 | 0.76 | 1.29 | Other |
| Hazard Ratio (HR) | 1.10 | 2-Sided | 95 | 0.77 | 1.56 | Other |
| Hazard Ratio (HR) | 0.79 | 2-Sided | 95 | 0.54 | 1.14 | Other |
| Hazard Ratio (HR) |
| 1.71 |
| 2-Sided |
| 95 |
| 1.07 |
| 2.72 |
| Other |
| Hazard Ratio (HR) | 1.16 | 2-Sided | 95 | 0.75 | 1.79 | Other |
| Hazard Ratio (HR) | 1.34 | 2-Sided | 95 | 1.01 | 1.76 | Other |
| Hazard Ratio (HR) | 1.52 | 2-Sided | 95 | 1.02 | 2.27 | Other |
| Hazard Ratio (HR) | 1.17 | 2-Sided | 95 | 0.81 | 1.71 | Other |
| Hazard Ratio (HR) |
| 1.31 |
| 2-Sided |
| 95 |
| 1.06 |
| 1.61 |
| Other |
| Hazard Ratio (HR) | 1.04 | 2-Sided | 95 | 0.84 | 1.29 | Other |
| Hazard Ratio (HR) | 1.04 | 2-Sided | 95 | 0.91 | 1.19 | Other |
| Hazard Ratio (HR) | 1.07 | 2-Sided | 95 | 0.90 | 1.27 | Other |
| Hazard Ratio (HR) | 0.91 | 2-Sided | 95 | 0.75 | 1.09 | Other |
| Hazard Ratio (HR) |
| 1.67 |
| 2-Sided |
| 95 |
| 0.61 |
| 4.58 |
| Other |
| Hazard Ratio (HR) | 1.84 | 2-Sided | 95 | 0.62 | 5.48 | Other |
| Hazard Ratio (HR) | 1.17 | 2-Sided | 95 | 0.57 | 2.40 | Other |
| Hazard Ratio (HR) | 0.96 | 2-Sided | 95 | 0.38 | 2.43 | Other |
| Hazard Ratio (HR) | 1.65 | 2-Sided | 95 | 0.64 | 4.27 | Other |