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

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

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.

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