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

N/ACompletedNCT02197078

Boehringer Ingelheim189,426 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

189,426

Conditions

Diabetes Mellitus, Type 2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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)