Diabetes Mellitus, Type 2
Conditions
Brief summary
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.
Interventions
DRUGTrazenta
1 tablet of 5 mg Trazenta tablets once daily
Sponsors
Eli Lilly and Company
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Drug Related Adverse Events | From first drug administration until last drug administration, up to approximately 156 weeks. | Percentage of participants with drug related adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c) | Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks. | The mean change from baseline to last observation of the treatment period in Haemoglobin A1c (HbA1c). |
Countries
Japan
Participant flow
Recruitment details
An observational, non-randomised, non-interventional study (NIS) in participants diagnosed with type 2 diabetes mellitus (T2DM) who were treated as add-on therapy were included in the surveillance based on newly collected data under routine medical practice. Acronym used: Case report form (CRF)
Pre-assignment details
This non-randomized, post marketing surveillance (PMS) was a prospective study using a continuous investigation system. No specific criteria (e.g., demographics, baseline characteristics, concomitant drugs in use) were defined for participant enrolment. Participants were enrolled from July 2013 to September 2015.
Participants by arm
| Arm | Count |
|---|---|
| Trazenta® Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration. | 3,372 |
| Total | 3,372 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 271 |
| Overall Study | CRF not collected | 117 |
| Overall Study | Improvement | 141 |
| Overall Study | Lack of Efficacy | 370 |
| Overall Study | Lost to Follow-up | 674 |
| Overall Study | No patient visit after entry | 54 |
| Overall Study | Reason not listed | 147 |
Baseline characteristics
| Characteristic | Trazenta® | — |
|---|---|---|
| Age, Continuous | 66.5 Years STANDARD_DEVIATION 12.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1308 Participants | — |
| Sex: Female, Male Male | 2064 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 74 / 3,372 |
| other Total, other adverse events | 184 / 3,372 |
| serious Total, serious adverse events | 304 / 3,372 |
Outcome results
Primary
Percentage of Participants With Drug Related Adverse Events
Percentage of participants with drug related adverse events.
Time frame: From first drug administration until last drug administration, up to approximately 156 weeks.
Population: Safety set: This patient set included all patients who were dispensed Trazenta® Tablets as add-on therapy, and had at least 1 observation after treatment. The patients treated with Trazenta® Tablets as monotherapy were not included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trazenta® | Percentage of Participants With Drug Related Adverse Events | 11.39 Percentage (%) of participants |
Secondary
The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c)
The mean change from baseline to last observation of the treatment period in Haemoglobin A1c (HbA1c).
Time frame: Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks.
Population: Efficacy set: This patient set included all patients with Trazenta® Tablets in the safety set who had a baseline and at least one available on-treatment HbA1c value and had type 2 diabetes mellitus.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trazenta® | The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c) | -0.49 Percentage (%) | Standard Deviation 1.33 |