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

Boehringer Ingelheim

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Study type

Observational

Funder types

Industry

Identifiers

NCT02197078

1218.163

Details and patient eligibility

About

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.

Enrollment

189,426 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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