N/A
Completed N=4,057
PMS of Trazenta on the Long-term Use as Add-on Therapy
Source: ClinicalTrials.gov NCT01904383 ↗Enrolled (actual)
4,057
Serious AEs
9.0%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants With Drug Related Adverse Events — 11.39 Percentage (%) of participants
Summary
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Drug Related Adverse Events |
11.39 | — |
| SECONDARY The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c) |
-0.49 | — |
Eligibility Criteria
Inclusion criteria
Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.
Exclusion criteria
None
Data sourced from ClinicalTrials.gov (NCT01904383). 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.