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

Boehringer Ingelheim logo

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

Trial design

189,426 participants in 4 patient groups

Glitazones
Linagliptin
Sulfonylurea
Within-class comparators

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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