N/A
Completed N=4,876
Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01650259 ↗Enrolled (actual)
4,876
Serious AEs
5.2%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants With Adverse Drug Reactions (ADRs) — 10.74 Percentage of Participants
Summary
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs) |
10.74 | — |
| SECONDARY Change From Baseline in HbA1c at the Last Observation During the Observation Period. |
-0.67 | — |
Eligibility Criteria
Inclusion criteria
- Male and female patients with type 2 Diabetes Mellitus who have never been treated with Trazenta tablets / Linagliptin (monotherapy) before enrollment. (Trazenta group)
- Patients with type 2 Diabetes Mellitus starting any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug (OAD)) except Trazenta tablets. (OAD group)
Exclusion criteria
None
Data sourced from ClinicalTrials.gov (NCT01650259). 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.