Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin

Study Overview
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Brief Summary
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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.

Official Title
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Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin

Conditions
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Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: A dispensing of an oral hypoglycemic medication A diagnosis of type 2 diabetes mellitus (T2DM) Exclusion criteria: less than 18 years old missing or ambiguous age or sex information at least one diagnosis of type 1 diabetes mellitus less than 6 months enrolment in the database preceding the date of the first dispensing secondary diabetes history of cancer end-stage renal disease (ESRD) HIV organ transplant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glitazones<br> | |
| Linagliptin<br> | |
| Sulfonylurea<br> | |
| Within-class comparators<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: Coronary revascularization (elective and non-elective procedure) Acute coronary syndrome (ACS), including acute myocardial infarction (MI) Stroke (Ischemic and hemorrhagic stroke) | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |