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

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT02197078
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-22
• Study Start: 2014-07-30
• Primary Completion: 2019-02-26
• Study Completion: 2019-02-26
• Results First Submitted: 2020-02-19
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-19
• Last Update Submitted: 2020-03-19
• Results First Posted: 2020-04-02
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189426

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute Coronary Syndrome	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	Up to 5 years and 7 month	Number of participants with coronary revascularization (elective and non-elective procedure)
Number of Participants With Stroke	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	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 Outcome Measures

Name	Time	Method
Number of Participants With Acute Renal Failure	Up to 5 years and 7 months	Number of participants with acute renal failure
Number of Participants With Incident End Stage Renal Disease	Up to 5 years and 7 months	Number of participants with incident end stage renal disease (ESRD)
Number of Participants With Acute Renal Failure Requiring Dialysis	Up to 5 years and 7 months	Number of patients with acute renal failure requiring dialysis
Number of Participants With Heart Failure Hospitalization	Up to 5 years and 7 months	Number of participants with heart failure hospitalization

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States