Diabetes Mellitus, Type 2
Conditions
Brief summary
Study objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care.
Interventions
DRUGTRADIANCE® Combination Tablets AP
Fixed dose combination
DRUGTRADIANCE® Combination Tablets BP
Fixed dose combination
Sponsors
Eli Lilly and Company
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Japanese patients with Type 2 Diabetes mellitus (T2DM) who are prescribed with TRADIANCE® Combination Tablets AP or BP * Patients who have never been treated with TRADIANCE® Combination Tablets AP or BP before enrolment
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions (ADRs) | From first dose of study medication until last dose + 7 days, up to 102.1 weeks. | The number of participants with adverse drug reactions is reported. |
Countries
Japan
Participant flow
Recruitment details
This was a non-interventional study based on newly collect data of patients under routine care to confirm safety of TRADIANCE® Combination Tablets AP and BP in real-world setting in Japanese patients with Type 2 Diabetes mellitus (T2DM).
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participants by arm
| Arm | Count |
|---|---|
| All Patients With Type 2 Diabetes Mellitus TRADIANCE® Combination Tablet AP or BP (fixed dose combination of empagliflozin and linagliptin) were administered orally once daily for patients with type 2 Diabetes Mellitus (T2DM). The TRADIANCE® Combination Tablet AP contains 10 milligrams (mg) empagliflozin and 5 mg linagliptin, while Tablet BP contains 25 mg empagliflozin and 5 mg linagliptin. Patients were followed up to 52 weeks. | 1,146 |
| Total | 1,146 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 37 |
| Overall Study | Case report form (CRF) not collected | 5 |
| Overall Study | Changing hospital | 11 |
| Overall Study | Excessive alcohol intake | 1 |
| Overall Study | Improvement/remission | 6 |
| Overall Study | Insufficient effectives | 2 |
| Overall Study | Lost to Follow-up | 33 |
| Overall Study | No patient visit after entry | 13 |
| Overall Study | Postoperative therapy of esophageal cancer | 1 |
| Overall Study | Prevention for recurrence of cystitis | 1 |
| Overall Study | Switch to other diabetes medication | 10 |
| Overall Study | Withdrawal by Subject | 19 |
Baseline characteristics
| Characteristic | All Patients With Type 2 Diabetes Mellitus | — |
|---|---|---|
| Age, Continuous | 63.8 Years STANDARD_DEVIATION 12.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 394 Participants | — |
| Sex: Female, Male Male | 752 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 1,146 |
| other Total, other adverse events | 0 / 1,146 |
| serious Total, serious adverse events | 40 / 1,146 |
Outcome results
Primary
Number of Participants With Adverse Drug Reactions (ADRs)
The number of participants with adverse drug reactions is reported.
Time frame: From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Population: Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Patients With Type 2 Diabetes Mellitus | Number of Participants With Adverse Drug Reactions (ADRs) | 32 Participants |