N/A
Completed N=724
A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea
Source: ClinicalTrials.gov NCT01903356 ↗Enrolled (actual)
724
Serious AEs
2.1%
Results posted
Dec 2018
Primary outcomePrimary: Incidence Rate of Adverse Events (AE) — 11.99 Percentage of patients (%)
Summary
The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Adverse Events (AE) |
11.99 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment. |
-0.75 | <0.0001 sig |
| SECONDARY Target Effectiveness Response Rate |
33.06 | — |
| SECONDARY Relative Effectiveness Response Rate |
46.78 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment. |
-17.12 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
Potential subjets must meet all of the following inclusion criteria to enter this trial:
- No previous exposure to Trajenta, Trajenta Duo
- Should have been started on Trajenta Duo in accordance with the approved label in Korea
- No current participation in clinical trials
- No metformin is inappropriate due to contraindications
- Must sign on the data release consent form
Exclusion criteria
Individuals with any of the following characteristics will not be able to enter this study:
- Previous exposure to Trajenta, Trajenta Duo
- Current participation in clinical trials
- Patients for whom metformin is inappropriate due to contraindications
Data sourced from ClinicalTrials.gov (NCT01903356). 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.