Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/23/2019 |
| Start Date: | July 30, 2014 |
| End Date: | March 15, 2019 |
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.
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
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