Diabetes Mellitus, Type 2
Conditions
Brief 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.
Detailed description
Study Design: Post Marketing study- Observational study
Interventions
DRUGTrajenta tablet
Linagliptin
Sponsors
Eli Lilly and Company
Boehringer Ingelheim
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta | Up to 26 weeks (long-term surveillance) | Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c) | Baseline and Week 24 | Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c). |
| Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment | 24 Weeks | Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of \< 6.5% after 24 weeks of treatment. |
| Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment) | 24 Weeks | Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment). |
| Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG) | Baseline and Week 24 | Change from baseline after 24 weeks in fasting plasma glucose (FPG). |
Countries
South Korea
Participant flow
Recruitment details
A regulatory requirement prospective, non-interventional, open-label, multi-centre national study to monitor the safety and effectiveness of Trajenta (Linagliptin, 5 milligram (mg), once daily) in Korean patients with type 2 diabetes mellitus
Pre-assignment details
All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.
Participants by arm
| Arm | Count |
|---|---|
| Trajenta (Linagliptin) 5 mg Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally. | 3,119 |
| Total | 3,119 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administered Trajenta prior to contract | 5 |
| Overall Study | Follow-up failure | 17 |
| Overall Study | Patients who have not taken Trajenta | 1 |
| Overall Study | Violated inclusion/exclusion criteria | 77 |
Baseline characteristics
| Characteristic | Trajenta (Linagliptin) 5 mg | — |
|---|---|---|
| Age, Continuous | 61.24 Years STANDARD_DEVIATION 11.95 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1450 Participants | — |
| Sex: Female, Male Male | 1669 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 3,119 |
| other Total, other adverse events | 0 / 3,119 |
| serious Total, serious adverse events | 49 / 3,119 |
Outcome results
Primary
Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta
Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.
Time frame: Up to 26 weeks (long-term surveillance)
Population: Safety analysis set: This analysis set included all patients who were administrated Trajenta at least once, except patients violating inclusion/exclusion criteria, dosage administration or lost to follow up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trajenta (Linagliptin) 5 mg | Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta | 7.69 Percentage of patients |
Secondary
Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)
Change from baseline after 24 weeks in fasting plasma glucose (FPG).
Time frame: Baseline and Week 24
Population: Effectiveness analysis set: the patients with the data available for FPG
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trajenta (Linagliptin) 5 mg | Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG) | Before drug administration | 161.19 Milligrams per Deciliter | Standard Deviation 55.38 |
| Trajenta (Linagliptin) 5 mg | Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG) | After drug administration | 143.51 Milligrams per Deciliter | Standard Deviation 46.76 |
p-value: <0.000195% CI: [-20.98, -15.12]Paired t-test
Secondary
Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)
Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c).
Time frame: Baseline and Week 24
Population: Effectiveness analysis set: This set includes all patients of the safety analysis set for whom HbA1c values were measured at both baseline and after drug administration.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trajenta (Linagliptin) 5 mg | Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c) | Before drug administration | 7.98 Percentage of HbA1c | Standard Deviation 1.51 |
| Trajenta (Linagliptin) 5 mg | Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c) | After drug administration | 7.21 Percentage of HbA1c | Standard Deviation 1.22 |
p-value: <0.000195% CI: [-0.83, -0.71]Paired t-test
Secondary
Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)
Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment).
Time frame: 24 Weeks
Population: Effectiveness analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trajenta (Linagliptin) 5 mg | Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment) | 57.30 Percentage of patients |
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
Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of \< 6.5% after 24 weeks of treatment.
Time frame: 24 Weeks
Population: Effectiveness analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trajenta (Linagliptin) 5 mg | 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 Percentage of patients |