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

Completed

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02197078

Run by

Boehringer Ingelheim

People needed

189426

Starts

2014-07-30

Expected to finish

2019-02-26

Last updated by the study team

2020-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A dispensing of an oral hypoglycemic medication
• A diagnosis of type 2 diabetes mellitus (T2DM)

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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