N/A
Completed N=189,426
Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin
Source: ClinicalTrials.gov NCT02197078 ↗Enrolled (actual)
189,426
Serious AEs
—
Results posted
Apr 2020
Primary outcomePrimary: Number of Participants With Major Adverse Cardiovascular Event — 165; 151; 120; 102 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Adverse Cardiovascular Event |
165; 151; 120; 102; 127; 82 | — |
| PRIMARY Number of Participants With Coronary Revascularization |
82; 81; 67; 54; 67; 46 | — |
| PRIMARY Number of Participants With Acute Coronary Syndrome |
93; 72; 76; 48; 72; 43 | — |
| PRIMARY Number of Participants With Stroke |
42; 42; 30; 30; 37; 16 | — |
| SECONDARY Number of Participants With Heart Failure Hospitalization |
53; 90; 27; 51; 43; 47 | — |
| SECONDARY Number of Participants With Incident End Stage Renal Disease |
49; 75; 28; 48; 38; 43 | — |
| SECONDARY Number of Participants With Acute Renal Failure |
222; 300; 152; 198; 163; 167 | — |
| SECONDARY Number of Participants With Acute Renal Failure Requiring Dialysis |
7; 13; 6; 10; 5; 9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02197078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.