Diabetes Mellitus, Type 2
Conditions
Brief 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.
Detailed description
Study Design: Post Marketed Study- Observational study
Interventions
DRUGTrajenta duo
Linagliptin and Metformin
Sponsors
Eli Lilly and Company
Boehringer Ingelheim
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Potential subjets must meet all of the following inclusion criteria to enter this trial: 1. No previous exposure to Trajenta, Trajenta Duo 2. Should have been started on Trajenta Duo in accordance with the approved label in Korea 3. No current participation in clinical trials 4. No metformin is inappropriate due to contraindications 5. 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: 1. Previous exposure to Trajenta, Trajenta Duo 2. Current participation in clinical trials 3. Patients for whom metformin is inappropriate due to contraindications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Adverse Events (AE) | Up to 26 weeks | The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment. | Baseline and Week 24 | This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range. |
| Target Effectiveness Response Rate | 24 Weeks | Occurrence of treatment to target effectiveness response is an HbA1c under treatment of \< 6.5% after 24 weeks of treatment. This outcome measures percentage of patients achieving HbA1c \< 6.5% after 24 weeks. |
| Relative Effectiveness Response Rate | 24 Weeks | Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks. |
| Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment. | 24 Weeks | This outcome has measured difference between Fasting Plasma Glucose (FPG) values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. |
Countries
South Korea
Participant flow
Recruitment details
This is an observational study in patients with type 2 diabetes mellitus who had been administered with TrajentaDuo® Tablets. The Case Report Forms of 724 subjects investigated by 15 investigators at 14 hospitals were retrieved from November 15, 2012 up to September 13, 2017.
Pre-assignment details
All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be enrolled in the study if any one of the specific entry criteria were violated.
Participants by arm
| Arm | Count |
|---|---|
| TrajentaDuo® Tablet Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet | 709 |
| Total | 709 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Violated inclusion/exclusion criteria | 5 |
| Overall Study | Violated the dosage and administration | 3 |
Baseline characteristics
| Characteristic | TrajentaDuo® Tablet | — |
|---|---|---|
| Age, Continuous | 62.04 Years STANDARD_DEVIATION 11.56 | — |
| Hemoglobin A1c (HbA1c) at baseline | 7.78 Percentage of HbA1c (%) STANDARD_DEVIATION 1.35 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 358 Participants | — |
| Sex: Female, Male Male | 351 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 709 |
| other Total, other adverse events | 0 / 709 |
| serious Total, serious adverse events | 15 / 709 |
Outcome results
Primary
Incidence Rate of Adverse Events (AE)
The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo
Time frame: Up to 26 weeks
Population: Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TrajentaDuo® Tablet | Incidence Rate of Adverse Events (AE) | 11.99 Percentage of patients (%) |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.
This outcome has measured difference between Fasting Plasma Glucose (FPG) values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication.
Time frame: 24 Weeks
Population: Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TrajentaDuo® Tablet | Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment. | -17.12 Milligram/deciLitre (mg/dL) | Standard Deviation 52.6 |
Comparison: Comparison of FPG before and 24 weeks after administration of TrajentaDuo® Tablet treatmentp-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.
This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.
Time frame: Baseline and Week 24
Population: Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TrajentaDuo® Tablet | Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment. | -0.75 Percentage (%) of HbA1c | Standard Deviation 1.48 |
Comparison: Comparison of % of HbA1c before and 24 weeks after administration of TrajentaDuo® Tablet treatment.p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Relative Effectiveness Response Rate
Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks.
Time frame: 24 Weeks
Population: Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TrajentaDuo® Tablet | Relative Effectiveness Response Rate | 46.78 Percentage of patients (%) |
Secondary
Target Effectiveness Response Rate
Occurrence of treatment to target effectiveness response is an HbA1c under treatment of \< 6.5% after 24 weeks of treatment. This outcome measures percentage of patients achieving HbA1c \< 6.5% after 24 weeks.
Time frame: 24 Weeks
Population: Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TrajentaDuo® Tablet | Target Effectiveness Response Rate | 33.06 Percentage of Patients (%) |