Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 189426
- Locations
- 1
- Primary Endpoint
- Number of Participants With Acute Coronary Syndrome
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Acute Coronary Syndrome
Time Frame: Up to 5 years and 7 months
Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately.
Number of Participants With Coronary Revascularization
Time Frame: Up to 5 years and 7 month
Number of participants with coronary revascularization (elective and non-elective procedure)
Number of Participants With Stroke
Time Frame: Up to 5 years and 7 months
Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately
Number of Participants With Major Adverse Cardiovascular Event
Time Frame: Up to 5 years and 7 months
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)
Secondary Outcomes
- Number of Participants With Acute Renal Failure(Up to 5 years and 7 months)
- Number of Participants With Incident End Stage Renal Disease(Up to 5 years and 7 months)
- Number of Participants With Acute Renal Failure Requiring Dialysis(Up to 5 years and 7 months)
- Number of Participants With Heart Failure Hospitalization(Up to 5 years and 7 months)