N/A
Completed N=3,219
A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01707147 ↗Enrolled (actual)
3,219
Serious AEs
1.6%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta — 7.69 Percentage of patients
Summary
The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta |
7.69 | — |
| SECONDARY Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c) |
7.98; 7.21 | <0.0001 sig |
| SECONDARY Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment |
26.02 | — |
| SECONDARY Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment) |
57.30 | — |
| SECONDARY Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG) |
161.19; 143.51 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
Patients who have been started on Trajenta in accordance with the approved label in Korea Patients who have signed on the data release consent form
Exclusion criteria
Patients with previous exposure to Trajenta and current participation in clinical trials
Data sourced from ClinicalTrials.gov (NCT01707147). 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.