Active surveillance research program for the assessment of the safety and the effectiveness of linagliptin

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS5790
• Study ID:
  7474
• Official title and acronym:
  Active surveillance research program for the assessment of the safety and the effectiveness of linagliptin
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  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 status:
  Finalised

Research institutions and networks

Institutions

Brigham and Women's Hospital

Study timelines

Date when funding contract was signed

Planned:28/12/2012

Actual:28/12/2012

Study start date

Planned:28/07/2014

Actual:01/09/2014

Data analysis start date

Planned:31/07/2014

Actual:15/09/2014

Date of interim report, if expected

Planned:31/10/2014

Date of final study report

Planned:30/04/2018

Actual:27/09/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

1218.163
NCT02197078